FDA Registration for OTC Cough Drug Products
OTC cough, cold, and allergy products containing dextromethorphan, guaifenesin, or antihistamines are regulated as OTC Monograph drugs by FDA — requiring establishment registration and listing.
FDA Requirements for OTC Cough Drug Products
OTC cough drug products are regulated under FDA’s OTC Monograph system. Permitted active ingredients include dextromethorphan HBr (cough suppressant), guaifenesin (expectorant), and diphenhydramine HCl (antihistamine/cough suppressant).
- FDA Drug Establishment Registration
- NDC Labeler Code
- Drug Listing with Drug Facts labeling
- Annual renewal October 1–December 31
The Food and Drug Administration (FDA) has established a set of regulations called the “OTC monograph” for over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic drugs. This monograph outlines the conditions under which these medications are considered safe and effective for self-treatment. It ensures ingredients, dosage amounts, and labeling meet specific criteria. The goal is to make sure these common medications are helpful for mild symptoms while preventing misuse or misleading claims.
M012.12 Antihistamine active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
| Brompheniramine maleate | M012.12 (Part 341) |
| Chlorcyclizine hydrochloride | M012.12 (Part 341) |
| Chlorpheniramine maleate | M012.12 (Part 341) |
| Dexbrompheniramine maleate | M012.12 (Part 341) |
| Dexchlorpheniramine maleate | M012.12 (Part 341) |
| Diphenhydramine citrate | M012.12 (Part 341) |
| Diphenhydramine hydrochloride | M012.12 (Part 341) |
| Doxylamine succinate | M012.12 (Part 341) |
| Phenindamine tartrate | M012.12 (Part 341) |
| Pheniramine maleate | M012.12 (Part 341) |
| Pyrilamine maleate | M012.12 (Part 341) |
| Thonzylamine hydrochloride | M012.12 (Part 341) |
| Triprolidine hydrochloride | M012.12 (Part 341) |
M012.14 Antitussive active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
Oral antitussives
| M012.14 (Part 341) |
Topical antitussives
| M012.14 (Part 341 |
M012.16 Bronchodilator active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
| Ephedrine | M012.16 (Part 341) |
| Ephedrine hydrochloride | M012.16 (Part 341) |
| Ephedrine sulfate | M012.16 (Part 341) |
| Epinephrine | M012.16 (Part 341) |
| Epinephrine bitartrate | M012.16 (Part 341) |
| Racephedrine hydrochloride | M012.16 (Part 341) |
| Racepinephrine hydrochloride | M012.16 (Part 341) |
M012.18 Expectorant active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
| Guaifenesin | M012.18 (Part 341) |
M012.20 Nasal decongestant active ingredients
| Active Ingredients | OTC Monograph Number |
|---|---|
Oral nasal decongestants
| M012.20 (Part 341) |
Topical nasal decongestants
| M012.20 (Part 341) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
OTC Cough Drug Products — FAQs
Are OTC cough syrups regulated as drugs?
What active ingredients are permitted in OTC cough products?
Ready to Register Your Cough Drug Products?
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