Active ingredient
Dextromethorphan Hydrobromide
16 products in the FDA listing contain Dextromethorphan Hydrobromide, at strengths from 5 to 10 mg.
A cough suppressant that acts on the part of the brain that produces the cough reflex. Unlike menthol, it is an oral antitussive: it is swallowed and works systemically.
Strengths actually on the market
| Strength | Unit | Products | Share |
|---|---|---|---|
| 5 | mg per unit | 15 | 94% |
| 10 | mg per unit | 1 | 6% |
Counted from the 16 listings on this page. Share is of all products containing Dextromethorphan Hydrobromide, including any at a different unit. Strengths that openFDA records in a different unit are not mixed into this table, because a milligram per lozenge and a percentage by weight are not the same measurement.
What the monograph says
These are the passages of 21 CFR 341 that name dextromethorphan directly, quoted rather than summarised.
Antitussive active ingredients. The active ingredients of the product consist of any of the following when used within the dosage limits and in the dosage forms established for each ingredient in § 341.74(d): (a) Oral antitussives. (1) Chlophedianol hydrochloride. (2) Codeine ingredients. The following ingredients may be used only in combination in accordance with § 290.2 and 21 CFR 1308.15(c). (i) Codeine. (ii) Codeine phosphate. (iii) Codeine sulfate. (3) Dextromethorphan. (4) Dextromethorphan hydrobromide. (5) Diphenhydramine citrate. (6) Diphenhydramine hydrochloride. (b) Topical antitussives. (1) Camphor. (2) Menthol.21 CFR 341.14
(iii) For products containing dextromethorphan or dextromethorphan hydrobromide identified in § 341.14(a) (3) and (4). The dosage is equivalent to dextromethorphan hydrobromide. Adults and children 12 years of age and over: Oral dosage is 10 to 20 milligrams every 4 hours or 30 milligrams every 6 to 8 hours, not to exceed 120 milligrams in 24 hours, or as directed by a doctor. Children 6 to under 12 years of age: Oral dosage is 5 to 10 milligrams every 4 hours or 15 milligrams every 6 to 8 hours, not to exceed 60 milligrams in 24 hours, or as directed by a doctor. Children 2 to under 6 years of age: Oral dosage is 2.5 to 5 milligrams every 4 hours or 7.5 milligrams every 6 to 8 hours, not to exceed 30 milligrams in 24 hours, or as directed by a doctor. Children under 2 years of age: Consult a doctor.21 CFR 341.74(d)(1)(iii)
21 CFR 341, Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. 2025 annual edition, retrieved from govinfo on 4 September 2026. How the monograph system works.
What these labels claim
| Stated use | Products |
|---|---|
| Cough | 16 |
| Common cold symptoms | 15 |
| Sore throat | 14 |
| Sore mouth, gums and canker sores | 14 |
| Minor throat irritation | 6 |
Read from each product's own Uses statement in its FDA label. This site does not decide what a product is for and does not recommend one for any condition.
Every listing
FDA National Drug Code Directory, retrieved 4 September 2026, openFDA data last updated 2 September 2026. A listing is a registration, not an inventory: a product here may not be on a shelf, and a product on a shelf may have a lapsed listing. See methodology.
Lozenges.com is a reference publication built from FDA product listings and drug labels. It is not medical advice, diagnosis or treatment, it does not recommend any product for any condition, and it is not a substitute for a pharmacist or a doctor.