Quick answers
- What is Carbamide peroxide used for?
- The Drug Facts label of ClearCanal Ear Wax Softerner Drops (NeilMed Pharmaceuticals, Inc.) lists these uses: Ear Wax Removal Drops Directions Step 1 Ear Wax Removal Drops Directions: FOR USE IN THE EAR ONLY. Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing enclosed ear plugs in ear. Use twice daily for upto 4 days if needed or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with NeilMed ClearCanal rinsing system with special ear rinse adapter. Children under 12 years of age: consult a doctor. Ear Wax Removal Drops Directions Ear Wax Removal Drops Directions.
- Do I need a prescription for Carbamide peroxide?
- 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 Carbamide peroxide been recalled?
- FDA enforcement reports list 10 recalls of products on this page; the newest started June 25, 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.
ClearCanal Ear Wax Softerner Drops · NeilMed Pharmaceuticals, Inc.
Carbamide peroxide 65 mg/mL, solution/ drops (auricular (otic))
Active ingredient
Drug Facts Drug Facts: Active ingredient: CARBAMIDE PEROXIDE Drug Facts Drug Facts
Purpose
Softens ear wax. Ear wax removal drops
Uses
Ear Wax Removal Drops Directions Step 1 Ear Wax Removal Drops Directions: FOR USE IN THE EAR ONLY. Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing enclosed ear plugs in ear. Use twice daily for upto 4 days if needed or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with NeilMed ClearCanal rinsing system with special ear rinse adapter. Children under 12 years of age: consult a doctor. Ear Wax Removal Drops Directions Ear Wax Removal Drops Directions
Warnings
Do not use
If you have had an allergic reaction to carbamide peroxide. If you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor For more than four consecutive days
When using this product
void contact with the eyes Stop use ad ask a doctor if excessive ear wax remains after use of this product for four consecutive days. Children under 12 years of age: consult a doctor.
When using this product
* Avoid contact with the eyes
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.
Directions
Place 5 to 10 drops of 6.5% carbamide peroxide solution into e
Inactive ingredients
Glycerin, Oxyquinoline, Aloe Barbadensis, Chamomile
— FDA label of ClearCanal Ear Wax Softerner Drops, NeilMed Pharmaceuticals, Inc., effective August 17, 2026. See the official label on DailyMed →
Quality Choice Earwax Removal Drops Earwax Removal Aid · Chain Drug Marketing Association, Inc.
Carbamide peroxide 65 mg/mL, solution/ drops (topical)
Active ingredient
Carbamide peroxide 6.5% Purpose Earwax removal aid
Purpose
Earwax removal aid
Uses
for occasional use as an aid to soften, loosen, and remove excessive earwax.
Warnings
For use in the ear only
Ask a doctor before use if
you have:
- ear drainage or discharge
- ear pain
- irritation or rash in the ear
- dizziness
- an injury or perforation (hole) of the ear drum
- recently had ear surgery
When using this product
- avoid contact with the eyes.
Stop use and ask a doctor if
- you need to use for more than 4 days
- excessive earwax remains after use of this product.
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
FOR USE IN THE EAR ONLY Adults and children over 12 years of age:
- Tilt head sideways and place 5 to 10 drops into ear
- Tip of applicator should not enter ear canal
- Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear
- Use twice daily for up to 4 days if needed, or as directed by a doctor
- Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb or ear syringe Children under 12 years: Consult a doctor
Inactive ingredients
anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water
Questions?
1-800-328-5890
— FDA label of Quality Choice Earwax Removal Drops Earwax Removal Aid, Chain Drug Marketing Association, Inc., effective June 10, 2026. See the official label on DailyMed →
Good Neighbor Pharmacy Earwax Removal Drops · Preferred Pharmaceuticals Inc.
Carbamide peroxide 65 mg/mL, liquid (topical)
Active ingredient
Carbamide peroxide 6.5% Purpose Earwax removal aid
Purpose
Earwax removal aid
Uses
for occasional use as an aid to soften, loosen, and remove excessive earwax
Warnings
For use in the ear only Ask a doctor beofre use if you have
- ear drainage or discharge
- ear pain
- irritation, or rash in the ear
- dizziness
- an injury or perforation (hole) of the ear drum
- recently had ear surgery
When using this product
avoid contact with the eyes
Stop use and ask a doctor if
- you need to use for more than 4 days
- excessive earwax remains after use of this product
Keep out of reach of children
If swallowed get medical help or contact a Poison Control Center right away.
Directions
FOR USE IN THE EAR ONLY Adults and children over 12 years of age:
- Tilt head sideways and place 5 to 10 drops into ear
- Tip of applicator should not enter ear canal
- Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear
- Use twice daily for up to 4 days if needed, or as directed by a doctor
- Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe
- consult a doctor Children under 12 years:
Inactive ingredients
anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water
Questions?
1-800-328-5890
— FDA label of Good Neighbor Pharmacy Earwax Removal Drops, Preferred Pharmaceuticals Inc., effective April 9, 2026. See the official label on DailyMed →
Ear Wax Removal Aid Drops · Pharmacy Value Alliance, LLC
Carbamide peroxide 0.065 mg/mL, liquid (auricular (otic))
Active ingredient
Carbamide Peroxide 6.5%
Purpose
Earwax removal aid
Uses
For occasional use as an aid to soften, loosen and remove excessive ear wax
Warnings
Ask a doctor before use if
you have
- ear drainage or discharge
- ear pain
- irritation or rash in the ear
- dizziness
- an injury or perforation (hole) of the eardrum
- recently had ear surgery
When using this product
avoid contact with the eyes
Stop use and ask a doctor if
- you need to use for more than four days
- excessive ear wax remains after use this product
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222).
Directions
FOR USE IN THE EAR ONLY.
- Adults and children over 12 years of age:
- tilt head sideways
- place 5 to 10 drops into ear canal.
- tip of applicator should not enter ear canal.
- keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear.
- use twice daily for up to four days if needed, or as directed by a doctor.
- any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. Children under 12 years of age: consult a doctor.
Inactive ingredients
adipic acid, anhydrous glycerin, polysorbate 80.
Questions?
1-866-467-2748
— FDA label of Ear Wax Removal Aid Drops, Pharmacy Value Alliance, LLC, effective October 28, 2024. See the official label on DailyMed →
Ear Drops Major · A-S Medication Solutions
Carbamide peroxide 6.5%, liquid (auricular (otic))
Active ingredient
Carbamide Peroxide 6.5%
Purpose
Earwax Removal Aid
Uses
For occasional use as an aid to soften. loosen and remove excessive earwax.
Warnings
Ask doctor before use if you have
- ear drainage or discharge
- ear pain
- irritation or rash in ear
- dizziness
- an injury or perforation (hole) of the eardrum
- recently had ear surgery
When using this product
avoid contact with eyes Stop and ask doctor before use if
- you need to use for more than four days
- excessive earwax remains after use of this product
Stop use and ask a doctor if
you need to use for more than four days
- excessive earwax remains after use of this product Keep out of reach of the children If product is swallowed, get medical help or contact a Poison Control Center right away If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- For use in the ear only. Adults and children over 12 years of age:
- tilt head sideways and place 5 to 10 drops into ear
- tip of applicator should not enter ear canal
- keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear
- use twice daily for up to 4 days if needed, or as directed by a doctor
- any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe Children under 12 years of age: consult a doctor.
Inactive ingredients
Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water
— FDA label of Ear Drops Major, A-S Medication Solutions, effective January 8, 2024. See the official label on DailyMed →
GoodSense Ear Wax Removal Kit · Preferred Pharmaceuticals Inc.
Carbamide peroxide 6.5%, liquid (topical)
Active ingredient
Carbamide Peroxide 6.5%
Purpose
Earwax removal aid
Uses
For occasional use as an aid to soften, loosen, and remove excessive earwax.
Warnings
Do not use
- if you have ear drainage or discharge, ear pain, irritation or rash in the ear or are dizzy; consult a doctor
- if you have an injury or perforation (hole) in the ear drum or after ear surgery, unless directed by a doctor
- for more than 4 days; if excessive earwax remains after use of this product, consult a doctor
When using this product
avoid contact with yes. If accidental contact with yes occurs, flush eyes with water and consult a doctor.
Keep out of reach of children
If the product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
FOR USE IN EAR ONLY. Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to 4 days if needed, or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. Children under 12 years of age: consult a doctor.
Inactive ingredients
Citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid Relabeled By: Preferred Pharmaceuticals Inc.
— FDA label of GoodSense Ear Wax Removal Kit, Preferred Pharmaceuticals Inc., effective April 9, 2026. 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.
Carbamide peroxide 65 mg/mL · solution/ drops (auricular (otic)) · 17 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Audiologists Choice Earwax Removal Aid Drops | Oaktree Products Inc | DailyMed |
| Best Choice Earwax Removal Drops | Valu Merchandisers Company | DailyMed |
| Carbamide peroxide 6.5% | Allegiant Health | DailyMed |
| CareOne Earwax Removal Drops | Retail Business Services, LLC | — |
| Clearcanal Ear Wax Softerner Drops | A-S Medication Solutions | DailyMed |
| ClearCanal Ear Wax Softerner Drops | NeilMed Pharmaceuticals, Inc. | DailyMed |
| Discount Drug Mart Earwax Removal Drops | Discount Drug Mart | DailyMed |
| Meijer Earwax Removal Drops | Meijer Distribution Inc | DailyMed |
| NeilMed Clear Canal Earwax Removal kit | Neilmed Pharmaceuticals Inc | DailyMed |
| Otix Ear wax Removal Drops | Bell Pharmaceuticals, Inc. | DailyMed |
| ProRinse Earwax Removal System | McKeon Products Inc | DailyMed |
| SuavEar Earwax Removal Aid | Neilmed Pharmaceuticals Inc | DailyMed |
| Tech Care Earwax Removal Drops | Warner Tech-care Products, LLC | DailyMed |
| TopCare Earwax Removal Drops | Topco Associates LLC | DailyMed |
| Wax Away Earwax Removal Aid | McKeon Products Inc | DailyMed |
| Wax Away Earwax Removal System | McKeon Products Inc | DailyMed |
| Wax Out Plus | Neilmed Pharmaceuticals Inc | DailyMed |
Carbamide peroxide 65 mg/mL · solution/ drops (topical) · 12 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| CVS Health Earwax Removal Drops Earwax Removal Aid | CVS Pharmacy, Inc. | DailyMed |
| DG Health Earwax Removal kit | Dollar General Corporation | DailyMed |
| Ear Wax Removal Drops | GeriCare Pharmaceutical Corp | DailyMed |
| Ear Wax Removal Drops | Sheffield Pharmaceuticals LLC | DailyMed |
| Ear Wax Removal Drops Equate | Walmart Stores Inc | DailyMed |
| Ear Wax Removal Drops Up and Up | Target Corporation | DailyMed |
| Foster and Thrive Earwax Removal Drops | A-S Medication Solutions | DailyMed |
| Foster and Thrive Earwax Removal Drops | McKesson Corp. Via Strategic Sourcing Services | DailyMed |
| Leader Earwax Removal Drops Earwax Removal Aid | Cardinal Health, Inc. | DailyMed |
| Major Earwax Removal Drops Earwax Removal Aid | Major Pharmaceuticals | DailyMed |
| Quality Choice Earwax Removal Drops Earwax Removal Aid | Chain Drug Marketing Association, Inc. | DailyMed |
| Wax B Gone Ear Wax Removal Drops | Sigmar, LLC | DailyMed |
Carbamide peroxide 65 mg/mL · liquid (topical) · 9 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Audiologists Choice Earwax Removal System | Oaktree Products Inc. | DailyMed |
| Best Choice Earwax Removal Kit | Valu Merchandisers, Co. | DailyMed |
| Equaline Earwax Removal Drops | United Natural Foods | DailyMed |
| Good Neighbor Pharmacy Earwax Removal Drops | Amerisource Bergen | DailyMed |
| Good Neighbor Pharmacy Earwax Removal Drops | Preferred Pharmaceuticals Inc. | DailyMed |
| Good Neighbor Pharmacy Earwax Removal Drops | Proficient Rx LP | DailyMed |
| Meijer Earwax Removal Kit | Meijer Distribution Inc. | DailyMed |
| Quality Choice Earwax Removal Drops | Chain Drug Marketing Association, Inc. | DailyMed |
| Quality Choice Earwax Removal Kit | Chain Drug Marketing Association, Inc. | DailyMed |
Carbamide peroxide 0.065 mg/mL · liquid (auricular (otic)) · 9 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Ear Drops | Bionpharma Inc. | — |
| Ear Drops | CVS Pharmacy | DailyMed |
| Ear Wax Removal Aid Drops | Pharmacy Value Alliance, LLC | DailyMed |
| Ear Wax Removal Aid Drops | Target Corporation | DailyMed |
| Earwax Removal Drops | Humco Holding Group, Inc | DailyMed |
| Earwax Removal Drops | Pharma Nobis, LLC | DailyMed |
| Earwax Removal Drops | Randob Labs, Ltd. | DailyMed |
| Family Care Earwax Removal | United Exchange Corp. | DailyMed |
| Walgreens Ear Wax Remover | Walgreens Company | DailyMed |
Carbamide peroxide 6.5% · liquid (auricular (otic)) · 6 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| DoloEar | Pharmadel LLC | DailyMed |
| Ear Drops Major | A-S Medication Solutions | DailyMed |
| EAR WAX RMVL Rite Aid | Rite Aid | DailyMed |
| ENT Essentials Ear Wax Remvoer | Wisconsin Pharmacal Company | DailyMed |
| Freskaro Earwax Removal Aid | Pharma Nobis, LLC | DailyMed |
| WaxRx Ear Wax Removal Aid Drops | Doctor Easy Medical Products, LLC | DailyMed |
Carbamide peroxide 6.5% · liquid (topical) · 5 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| ERO Ear Wax Removal Kit | Randob Labs | DailyMed |
| GoodSense Ear Wax Removal Kit | Geiss, Destin & Dunn, Inc | DailyMed |
| GoodSense Ear Wax Removal Kit | Preferred Pharmaceuticals Inc. | DailyMed |
| Harris Teeter Earwax Removal Drops | Harris Teeter LLC | DailyMed |
| Rite Aid Earwax Removal Drops | Rite Aid | DailyMed |
Carbamide peroxide 65 mg/mL · liquid (auricular (otic)) · 4 products
| Brand or product name | Company on the label | Label |
|---|---|---|
| Debrox | A-S Medication Solutions | DailyMed |
| Debrox | Medtech Products Inc. | DailyMed |
| Ear Wax Removal Aid Drops | Better Living Brands, LLC | DailyMed |
| TopCare Earwax Removal Kit | Topco Associates LLC | DailyMed |
Carbamide peroxide 100 mg/mL · liquid (oral) · 1 product
| Brand or product name | Company on the label | Label |
|---|---|---|
| Gly-Oxide | Medtech Products Inc. | DailyMed |
Carbamide peroxide 0.065 g/mL · liquid (auricular (otic)) · 1 product
| Brand or product name | Company on the label | Label |
|---|---|---|
| Clinere Ear Wax Remover | Quest Products | DailyMed |
Carbamide peroxide 7.8 mg/12 mL · liquid (topical) · 1 product
| Brand or product name | Company on the label | Label |
|---|---|---|
| Auralyt | Menper Distributors, Inc | DailyMed |
Carbamide peroxide 6.5 mg/mL · solution (auricular (otic)) · 1 product
| Brand or product name | Company on the label | Label |
|---|---|---|
| Healthy Ears | Vitamex USA, Corp | DailyMed |
Carbamide peroxide 65 mg/mL · solution (topical) · 1 product
| Brand or product name | Company on the label | Label |
|---|---|---|
| DISCOUNT drug mart FOOD FAIR earwax removal kit | Discount Drug Mart | DailyMed |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| carbamide peroxide 65 mg/mL liquid | Generic | $0.1631 per mL |
| carbamide peroxide 65 mg/mL solution/ drops | Generic | $0.1631 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- A-S Medication Solutions4 products
- NeilMed Pharmaceuticals, Inc.4 products
- McKeon Products Inc3 products
- Chain Drug Marketing Association, Inc.3 products
- Topco Associates LLC2 products
- Medtech Products Inc.2 products
- Preferred Pharmaceuticals Inc.2 products
- Oaktree Products Inc2 products
- Pharma Nobis, LLC2 products
- Target Corporation2 products
- Meijer Distribution Inc2 products
- Rite Aid2 products
- Discount Drug Mart2 products
- Doctor Easy Medical Products, LLC1 product
- Walmart Stores Inc1 product
- Valu Merchandisers, Co.1 product
- United Natural Foods1 product
- Humco Holding Group, Inc1 product
- Quest Products1 product
- Dollar General Corporation1 product
- Menper Distributors, Inc1 product
- Pharmadel LLC1 product
- Vitamex USA, Corp1 product
- Proficient Rx LP1 product
- Pharmacy Value Alliance, LLC1 product
- Wisconsin Pharmacal Company1 product
- Walgreens Company1 product
- Cardinal Health, Inc.1 product
- Major Pharmaceuticals1 product
- Sheffield Pharmaceuticals LLC1 product
Showing the 30 companies with the most products, of 48.
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.
-
June 25, 2026 · Class II · Ongoing · D-0682-2026
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005. — Bell Pharmaceuticals, Inc
-
June 25, 2026 · Class II · Ongoing · D-0680-2026
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376. — Bell Pharmaceuticals, Inc
-
June 25, 2026 · Class II · Ongoing · D-0679-2026
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Pra — Bell Pharmaceuticals, Inc
-
June 25, 2026 · Class II · Ongoing · D-0678-2026
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895, — Bell Pharmaceuticals, Inc
-
June 25, 2026 · Class II · Ongoing · D-0687-2026
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. — Bell Pharmaceuticals, Inc
-
June 25, 2026 · Class II · Ongoing · D-0681-2026
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. — Bell Pharmaceuticals, Inc
-
June 25, 2026 · Class II · Ongoing · D-0684-2026
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, — Bell Pharmaceuticals, Inc
-
June 25, 2026 · Class II · Ongoing · D-0685-2026
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017. — Bell Pharmaceuticals, Inc
-
June 25, 2026 · Class II · Ongoing · D-0688-2026
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785. — Bell Pharmaceuticals, Inc
-
June 29, 2022 · Class II · Terminated · D-1318-2022
CGMP Deviations: products were stored outside the drug label specifications.
Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per box), MedTech Products Inc., NDC 63029-321-01. — Mckesson Medical-Surgical Inc. Corporate Office
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.