Quick answers
- What is Benzocaine and dextromethorphan used for?
- The Drug Facts label of Cepacol Extra Strength Sore Throat and Cough (Reckitt Benckiser LLC) lists these uses: Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold pain associated with canker sores occasional irritation and pain due to a sore mouth or sore throat.
- Do I need a prescription for Benzocaine and dextromethorphan?
- 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 ingredients, 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 and dextromethorphan been recalled?
- No recall linked to these products appears in the FDA enforcement reports we use.
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.
Cepacol Extra Strength Sore Throat and Cough · Reckitt Benckiser LLC
Benzocaine 7.5 mg · Dextromethorphan hydrobromide 5 mg, lozenge (oral)
Active ingredient (in each lozenge)
Purposes Benzocaine 7.5 mg Oral pain reliever Dextromethorphan HBr 5 mg Cough suppressant
Purpose
Active ingredients (in each lozenge) Purposes Benzocaine 7.5 mg Oral pain reliever Dextromethorphan HBr 5 mg Cough suppressant
Uses
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold pain associated with canker sores occasional irritation and pain due to a sore mouth or sore throat
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. 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.
Do not use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. for teething in children under 6 years of age
Ask a doctor before use if
you have persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Stop use and ask a doctor or dentist if sore mouth symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling develops cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding
ask a health professional before use.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage.
Directions
| adults and children 12 years of age and older | take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 12 lozenges in 24 hours, or as directed by a doctor or dentist |
| children 6 to under 12 years of age | take 1 lozenge and allow product to dissolve slowly in the mouth; may be repeated every 4 hours as needed, not to exceed 6 lozenges in 24 hours, or as directed by a doctor or dentist |
| children under 6 years of age | do not use |
Inactive ingredients
FD&C blue no. 1, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose
Questions?
1-866-682-4639
— FDA label of Cepacol Extra Strength Sore Throat and Cough, Reckitt Benckiser LLC, effective May 13, 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 ingredients, 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 7.5 mg · Dextromethorphan hydrobromide 5 mg · lozenge (oral) · 7 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Cepacol Extra Strength Sore Throat and Cough | Reckitt Benckiser LLC | DailyMed |
| Equate Benz-Dex Cough and Throat Lozenges | Walmart | DailyMed |
| Mixed Berry Sore Throat and Cough lozenge | Meijer Distribution, Inc. | DailyMed |
| Mixed Berry Sore Throat and Cough Lozenges | Heb | DailyMed |
| Mixed Berry Sore Throat Lozenges | Topco Associates | DailyMed |
| Mixed Berry Throat and Cough Lozenges | CVS Pharmacy | DailyMed |
| Walgreens Mixed Berry Benz-Dex Lozenges | Walgreen | DailyMed |
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.
- Topco Associates1 product
- Walmart1 product
- Meijer Distribution, Inc.1 product
- Reckitt Benckiser LLC1 product
- Walgreen1 product
- Heb1 product
- CVS Pharmacy1 product
Recalls
No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.
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.