Quick answers
- What is Benzocaine used for?
- The Drug Facts label of BencoCaine Topical Anesthetic (Benco Dental) lists these uses: For oral mucosal use only, as directed by dentist. For the temporary relif of pain due to minor dental procedures..
- Do I need a prescription for Benzocaine?
- No. The products on this page are sold without a prescription (over the counter).
- Is a store brand the same as the name brand?
- Products listed together below have the same active ingredient, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
- Has Benzocaine been recalled?
- FDA enforcement reports list 13 recalls of products on this page; the newest started May 21, 2026. A recall usually concerns specific products or lots, not every brand.
Drug Facts label
Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.
BencoCaine Topical Anesthetic · Benco Dental
Benzocaine 20%, gel (dental)
Active ingredient
Benzocaine 200 mg (in each g)
Purpose
Oral Anesthetic
Uses
For oral mucosal use only, as directed by dentist. For the temporary relif of pain due to minor dental procedures.
Warnings
- Warnings Methemoglolllnemla warning: Use of this product may cause methemoglobinemia, a seriouscondit~n that must be treated promptly because tt reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray or blue colored skin (cyanosis)
- headache rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy
Do not use
- for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or worsens; or if swelling, rash or fever develops,see your physician promptly.
- for teething
- in children under 2 years of age
When using this product
Avoid contact with eyes. If contact occurs, flush with water. If pregnant or breast feeding, ask a physician before use.
Keep out of reach of children
Directions
- Apply only amount needed to the oral mucosa to prevent or relieve pain.
- children under 2 years of age: do not use
Other information
Allergy Alert Allergy Alert Do not use on patients with a history of allergies to local anesthetics suchasprocaine,butacaine, benzocaine or other "caine" anesthetics.
Inactive ingredients
flavoring, PEG 3350, PEG 400, sodium saccharin.
Questions?
800.GO.BENCO or benco.com
— FDA label of BencoCaine Topical Anesthetic, Benco Dental, effective January 8, 2025. See the official label on DailyMed →
Oral Pain Relief · Geri-Care Pharmaceutical Corp
Benzocaine 20%, gel (oral)
Active ingredient
Benzocaine 20%
Purpose
Oral anesthetic
Uses
temporary relieves pain associated with the following mouth and gum irritations:
- toothache
- sore gums
- canker sores
- braces
- minor dental procedures
- dentures
Warnings
METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy Allergy alert
Do not use
this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- for teething
- in children under 2 years of age
- more than recommended
- for more than 7 days unless told to do so by a dentist or doctor
When using this product
- avoid contact with the eyes
Stop use and ask a doctor if
- sore mouth symptoms do not improve in 7 days
- irritation, pain, or redness persists or worsens
- swelling, rash or fever develops
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- do not exceed recommended dosage
- do not use for more than 7 days unless told to do so by a dentist or doctor
- adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist
- children between 2 and 12 years of age: adult supervision should be given in use of this product
- children under 2 years of age: do not use
Inactive ingredients
Flavor, PEG-6, PEG-8, PEG-32, PEG-75, Sodium Saccharin, Sorbic Acid
Questions?
1-800-540-3765
— FDA label of Oral Pain Relief, Geri-Care Pharmaceutical Corp, effective October 31, 2023. See the official label on DailyMed →
Anbesol Maximum Strength · Foundation Consumer Brands
Benzocaine 20%, gel (topical)
Active ingredient
Benzocaine 20%
Purpose
Oral pain reliever
Uses
temporarily relieves pain associated with the following mouth and gum irritations: toothache sore gums canker sores braces minor dental procedures dentures
Warnings
METHEMOGLOBINEMIA WARNING Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy Allergy alert
Do not use
this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.
Do not use
for teething in children under 2 years of age
When using this product
avoid contact with the eyes do not exceed recommended dosage do not use for more than 7 days unless directed by a doctor/dentist
Stop use and ask a doctor if
sore mouth symptoms do not improve in 7 days irritation, pain, or redness lasts or worsens swelling, rash, or fever develops
Keep out of reach of children
If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
to open tube, cut tip of the tube on score mark with scissors
| adults and children 2 years of age and over | apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist |
| children under 12 years of age | adult supervision should be given in the use of this product |
| children under 2 years of age | do not use |
for denture irritation: apply thin layer to the affected area do not reinsert dental work until irritation/pain is relieved rinse mouth well before reinserting
Inactive ingredients
benzyl alcohol, carbomer homopolymer type b, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, saccharin
Questions?
Call 1-888-594-0673 weekdays 9 AM to 5 PM EST
— FDA label of Anbesol Maximum Strength, Foundation Consumer Brands, effective June 22, 2026. See the official label on DailyMed →
BODY ACTION PRODUCTS Anal Glide Extra · Product Max Group Inc
Benzocaine 50 mg/mL, gel (topical)
Active ingredient
Benzocaine 5% Purpose Anorectal (Hemorrhoidal) Gel
Purpose
Anorectal (Hemorrhoidal) Gel
Uses
For temporary relief of pain or soreness in the perianal area.
Warnings
For external use only. Avoid contact with the eyes. Certain persons can develop allergic reactions from ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
Keep out of reach of children
If swallowed get medical help or contact a Poison Control Center right away.
Directions
When practial, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Apply to the affected area up to 6 times daily.
Inactive ingredients
Hydroxyethylcellulose, Methylparaben, PEG-8, Propylene Glycol, Propylparaben, Water.
— FDA label of BODY ACTION PRODUCTS Anal Glide Extra, Product Max Group Inc, effective April 3, 2025. See the official label on DailyMed →
HurriCaine Topical Anesthetic Gel · Beutlich Pharmaceuticals, LLC
Benzocaine 20%, gel (dental, oral, periodontal)
Active ingredient
Benzocaine 20%
Purpose
Oral Anesthetic
Uses
for the temporary relief of occasional minor irritation and pain associated with: canker sores sore mouth and throat minor injury of the mouth and gums minor dental procedures minor irritation of the mouth and gums caused by dentures or orthodontic appliances
Warnings
- Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy Allergy alert
Do not use
if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.
- Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.
When using this product
When using this product
avoid contact with eyes
Do not use
Do not use
- if product film is punctured or damaged
- for teething
- in children under 2 years of age
Keep out of reach of children
Keep out of reach of children
If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Directions
- do not exceed recommended dosage adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor. children under 12 years of age: should be supervised in the use of the product children under 2 years of age: do not use
Inactive ingredients
flavor, polyethylene glycol, sodium saccharin
Questions?
1-800-238-8542 M-F: 8:00 a.m. to 4:30 p.m. ET
— FDA label of HurriCaine Topical Anesthetic Gel, Beutlich Pharmaceuticals, LLC, effective January 8, 2025. See the official label on DailyMed →
Iolite · Dharma Research, Inc.
Benzocaine 6.4%, gel (dental, oral)
Active ingredient
Benzocaine, 20%
Purpose
Oral anesthetic
Uses
For the temporary relief of pain associated with canker sores and minor dental procedures.
Warnings
Methemoglobinemia warning Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek medical attention if you or a child in your care develops:
- pale, gray, or blue colored skin (cyanosis)
- headache
- rapid heart rate
- shortness of breath
- dizziness or lightheadedness
- fatigue or lack of energy Alergy alert
Do not use
this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "-caine" anesthetics.
Do not use
this product for more than 7 days unless directed by a dentist or a doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly. Do not exceed recommended dosage. Keep Out of Reach of Children. If more than used for pain is accidentially swallowed, get medical help or contact a Poison Control center right away.
Directions
Adults and children 2 years of age and older: Apply to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product Children under 2 years of age: Consult a dentist or doctor.
Inactive ingredients
FD&C Red #40, FD&C Yellow #5, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol
— FDA label of Iolite, Dharma Research, Inc., effective October 10, 2023. See the official label on DailyMed →
This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.
Same medicine, other brands
Each group lists the products that have exactly the same active ingredient, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.
Benzocaine 20% · gel (dental) · 186 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Advance Topical Anesthetic Gel | The Atlanta Dental Supply Company DBA Advanced Dental Products | DailyMed |
| Anadent Kanka Gel | Belmora LLC | DailyMed |
| Astra-dent Topical Anesthetic Gel | Zag USA Inc | DailyMed |
| BencoCaine Topical Anesthetic | Benco Dental | DailyMed |
| Benzo-Jel | Henry Schein Inc. | DailyMed |
| Burkhart Topical Anesthetic | Burkhart Dental Supply Inc | DailyMed |
| Candee Caine Topical Anesthetic | American Medical & Hospital Supply Co., Inc. | DailyMed |
| Candee Caine Topical Anesthetic | Top Quality Manufacturing, Inc. | DailyMed |
| Comfortcaine Topical Anesthetic | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | DailyMed |
| Defend | Mydent International | DailyMed |
| Dental City Topical Anesthetic | ICP Inc DBA Dental City | DailyMed |
| Gelato Topical Anesthetic | Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc | DailyMed |
| GPS Topical Anesthetic | Group Practice Solutions, Inc. | DailyMed |
| Health-Tec Topical Anesthetic | Dental Health Products, Inc. | DailyMed |
| Ipana 20% Benzocaine Topical | Maxill Inc. | DailyMed |
| iSmile Topical Anesthetic | iSmile Dental Products, Inc. | DailyMed |
| Kolorz Topical Anesthetic Blue Rasberry | Dmg America, LLC | DailyMed |
| Kolorz Topical Anesthetic Cherry Burst | Dmg America, LLC | DailyMed |
| Kolorz Topical Anesthetic Cotton Candy | Dmg America, LLC | DailyMed |
| Kolorz Topical Anesthetic Pina Colada | Dmg America, LLC | DailyMed |
| Kolorz Topical Anesthetic Triple Mint | Dmg America, LLC | DailyMed |
| NRG Topical Anesthetic | IQ Dental Supply, LLC | DailyMed |
| Patterson Dental Topical Anesthetic | Patterson Dental | DailyMed |
| Pearson Topical Anesthetic | Pearson Dental Supplies Inc. | DailyMed |
| Primo Topical Anesthetic | Tri State Dental | DailyMed |
Showing 25 of 30 brands.
Benzocaine 20% · gel (oral) · 12 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Equate Orasol | Wal-Mart Stores Inc. | DailyMed |
| Family Wellness Pain Relief | FAMILY DOLLAR (Family Wellness) | DailyMed |
| NBE Anbesol | Walgreens | DailyMed |
| Oral pain relief | Alaina Healthcare Private Limited | DailyMed |
| Oral Pain Relief | Geri-Care Pharmaceutical Corp | DailyMed |
| Oral Pain Relief | Nantong Health & Beyond Hygienic Products Inc. | DailyMed |
| Oral Pain Relief | Universal Distribution Center LLC | DailyMed |
| Sheffield Pain Relief | Sheffield Pharmaceuticals LLC | DailyMed |
| Topicale Xtra | Medical Products Laboratories, Inc. | DailyMed |
| Walgreens Pain Relief | Walgreens Company | DailyMed |
Benzocaine 20% · gel (topical) · 12 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| 7 Select Oral Pain Maximum Strength Relief | 7-Eleven, Inc. | DailyMed |
| Anbesol Maximum Strength | Foundation Consumer Brands | DailyMed |
| Family Wellness Oral Pain Relief | Family Dollar Services Inc | DailyMed |
| Goodsense Oral Pain Relief | Geiss, Destin and Dunn, Inc. | DailyMed |
| Iodent Oral Analgesic | United Exchange Corp. | — |
| McKesson Orasol Gel | McKesson Medical-Surgical | DailyMed |
| MyMedic Oral Pain Relief Gel | Nantong Health & Beyond Hygienic Products Inc. | — |
| Oral Pain Relief Gel | Sled Distribution, LLC | DailyMed |
| Quality Choice | Chain Drug Marketing Association, Inc. | DailyMed |
| Quality Choice Maximum Strength Oral Pain Relieving | Chain Drug Marketing Association Inc | DailyMed |
| TopCare Oral Pain Relief Maximum Strength | Topco Associates LLC | DailyMed |
| WinCo Foods Maximum Strength Oral Analgesic | WinCo Foods, LLC | DailyMed |
Benzocaine 50 mg/mL · gel (topical) · 11 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| BODY ACTION PRODUCTS Anal Glide Extra | Product Max Group Inc | DailyMed |
| BODY ACTION PRODUCTS Butt Eze Benzocaine | Product Max Group Inc | DailyMed |
| BODY ACTION PRODUCTS Climax Control Gel | Product Max Group Inc | DailyMed |
| BODY ACTION PRODUCTS Endless Love for Men | Product Max Group Inc | DailyMed |
| BODY ACTION PRODUCTS Higher Control Male Climax | Product Max Group Inc | DailyMed |
| BODY ACTION PRODUCTS Prolong Lubricating | Product Max Group Inc | DailyMed |
| Endless Love For Men | Body Action Products, Inc | DailyMed |
| HIGHER CONTROL Male Climax Control Lubricating | Product Max Group Inc | DailyMed |
| INTIMALE Benzocaine Delay Gel | Skins Sexual Health Limited | DailyMed |
| POWERECT Benzocaine Male Delay Gel | Skins Sexual Health Limited | DailyMed |
| SKINS DELAY Climax Control Benzocaine Gel | Skins Sexual Health Limited | DailyMed |
Benzocaine 20% · gel (dental, oral, periodontal) · 10 products
Benzocaine 6.4% · gel (dental, oral) · 9 products
Benzocaine 200 mg · gel (dental, oral, periodontal) · 8 products
| Brand or product name | Company on the label | Label |
|---|---|---|
| GingiCaine Gel | Gingi-Pak a Division of the Belport | DailyMed |
| Gingicaine Gel Strawberry | Gingi-Pak a Division of the Belport | DailyMed |
| Gingicaine Gel Variety Pak | Gingi-Pak a Division of the Belport | DailyMed |
| GingiCaine gel, Cherry | Gingi-Pak a Division of the Belport | DailyMed |
| GingiCaine Gel, Chocolate Mint | Gingi-Pak a Division of the Belport | DailyMed |
| GingiCaine Gel, Cotton Candy Flavor | Gingi-Pak a Division of the Belport | DailyMed |
| GingiCaine Gel, Mint Julep | Gingi-Pak a Division of the Belport | DailyMed |
| GingiCaine Gel, Pina Colada | Gingi-Pak a Division of the Belport | DailyMed |
Benzocaine 7.5% · cream (topical) · 7 products
| Brand or product name | Company on the label | Label |
|---|---|---|
| Alphamale Delay Cream | Prodigy Media Inc | DailyMed |
| Anal Blu | Novelties by Nasswalk, Inc. | DailyMed |
| Anal-Ese | Novelties by Nasswalk, Inc. | DailyMed |
| Bravado Labs Delay Cream | Prodigy Media Inc | DailyMed |
| Do Me Delay Cream | Prodigy Media | DailyMed |
| Pure Primal Delay Cream | Prodigy Media Inc | DailyMed |
Benzocaine 6.4% · gel (dental) · 7 products
| Brand or product name | Company on the label | Label |
|---|---|---|
| Avant | Dharma Research, Inc. | DailyMed |
Benzocaine 20% · liquid (oral) · 7 products
| Brand or product name | Company on the label | Label |
|---|---|---|
| Mouth Sore Relief Professional Strength | CVS Pharmacy | DailyMed |
| Oral Anesthetic Liquid | Meijer, Inc. | DailyMed |
| Rexall Maximum Strength | Rexall | DailyMed |
| Rite Aid Maximum Strength | Rite Aid | DailyMed |
| Rite Aid Professional Strength | Rite Aid | DailyMed |
| Topcare Maximum Strength | Topco Associates LLC | DailyMed |
| Walgreens Maximum Strength | Walgreens | DailyMed |
Benzocaine 22% · gel (dental) · 6 products
| Brand or product name | Company on the label | Label |
|---|---|---|
| BENZOCAINE Bubble Gum | Darby Dental Supply, LLC | DailyMed |
| BENZOCAINE Cherry | Darby Dental Supply, LLC | DailyMed |
| BENZOCAINE Mint | Darby Dental Supply, LLC | DailyMed |
| BENZOCAINE Pina Colada | Darby Dental Supply, LLC | DailyMed |
| BENZOCAINE Raspberry | Darby Dental Supply, LLC | DailyMed |
| BENZOCAINE Strawberry | Darby Dental Supply, LLC | DailyMed |
Benzocaine 18% · gel (oral) · 5 products
| Brand or product name | Company on the label | Label |
|---|---|---|
| Topicale | Medical Products Laboratories, Inc. | DailyMed |
Benzocaine 20% · gel (dental, periodontal) · 5 products
Benzocaine 20% · ointment (topical) · 5 products
| Brand or product name | Company on the label | Label |
|---|---|---|
| Blt 1 | Centura Pharmaceuticals Inc | DailyMed |
| Boil Ease | Insight Pharmaceuticals LLC | DailyMed |
| CVS Maximum Strength Boil Relief | CVS Pharmacy, Inc. | DailyMed |
| Red Cross Canker Sore | The Mentholatum Company | DailyMed |
| Walgreens Boil Pain Relief | Walgreens Company | DailyMed |
Benzocaine 7.5% · spray (topical) · 4 products
Benzocaine 20% · gel, dentifrice (dental) · 4 products
Benzocaine 5% · cream (topical) · 4 products
Benzocaine 200 mg/mL · liquid (topical) · 3 products
Benzocaine 20% · liquid (dental, oral, periodontal) · 3 products
| Brand or product name | Company on the label | Label |
|---|---|---|
| HurriCaine Topical Anesthetic Liquid | Beutlich Pharmaceuticals, LLC | DailyMed |
Benzocaine 20% · liquid (topical) · 3 products
60 more strengths and forms are listed in the FDA NDC Directory.
Companies that sell this medicine
The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.
- Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc18 products
- Dharma Research, Inc.17 products
- Beutlich Pharmaceuticals, LLC17 products
- Benco Dental13 products
- Patterson Dental12 products
- Medical Products Laboratories, Inc.10 products
- Pearson Dental Supplies Inc.10 products
- Burkhart Dental Supply Inc10 products
- Product Max Group Inc10 products
- IQ Dental Supply, LLC9 products
- ICP Inc DBA Dental City9 products
- Tri State Dental9 products
- Henry Schein Inc.9 products
- Dental Health Products, Inc.8 products
- Zag USA Inc8 products
- PureLife Dental8 products
- Gingi-Pak a Division of the Belport8 products
- Mydent International7 products
- American Medical & Hospital Supply Co., Inc.6 products
- Novelties by Nasswalk, Inc.6 products
- Darby Dental Supply, LLC6 products
- Group Practice Solutions, Inc.6 products
- Top Quality Manufacturing, Inc.6 products
- Tiger Supply Inc.6 products
- The Atlanta Dental Supply Company DBA Advanced Dental Products6 products
- National Distribution & Contracting, Inc6 products
- iSmile Dental Products, Inc.6 products
- Safco Dental Supply Co.6 products
- CC Wellness LLC5 products
- Dmg America, LLC5 products
Showing the 30 companies with the most products, of 123.
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific products or lots: check the name and lot number on your package.
-
May 21, 2026 · Class II · Ongoing · D-0602-2026
Defective container:may contain bottles with incomplete seals
DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30 — Keystone Industries
-
May 21, 2026 · Class II · Ongoing · D-0601-2026
Defective container:may contain bottles with incomplete seals
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30. — Keystone Industries
-
May 21, 2026 · Class II · Ongoing · D-0603-2026
Defective container:may contain bottles with incomplete seals
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30 — Keystone Industries
-
May 21, 2026 · Class II · Ongoing · D-0600-2026
Defective container:may contain bottles with incomplete seals
Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3. — Keystone Industries
-
May 21, 2026 · Class II · Ongoing · D-0605-2026
Defective container:may contain bottles with incomplete seals
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30 — Keystone Industries
-
May 21, 2026 · Class II · Ongoing · D-0606-2026
Defective container:may contain bottles with incomplete seals
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1. — Keystone Industries
-
May 21, 2026 · Class II · Ongoing · D-0604-2026
Defective container:may contain bottles with incomplete seals
Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30 — Keystone Industries
-
November 14, 2024 · Class II · Terminated · D-0142-2025
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30. — Keystone Industries
-
November 14, 2024 · Class II · Terminated · D-0141-2025
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint Paul, MN 55120, NDC 50227-1002-3. — Keystone Industries
-
November 14, 2024 · Class II · Terminated · D-0137-2025
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30. — Keystone Industries
-
November 14, 2024 · Class II · Terminated · D-0145-2025
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professi — Keystone Industries
-
December 21, 2023 · Class I · Completed · D-0236-2024
Chemical Contamination: presence of benzene
Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made in India. NDC 63736 — Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
-
July 31, 2020 · Class III · Terminated · D-1541-2020
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. Oz. (3.7 mL) bottle with Cotton Pellets box packaged in a blister pack, Distributed by: Mentholatum Company, Orchard Park, NY 14127 NDC 1074 — The Mentholatum Company
Sources
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- FDA rule for the Drug Facts label (21 CFR 201.66)
Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.