The rule layer
The rules a cough drop has to follow
Nobody at FDA approved your packet of cough drops. That is not an oversight. Most over-the-counter medicine is sold under a monograph, which is a standing rule book for a whole category: stay inside it and you may sell the product without an individual approval. The monograph is why every menthol lozenge in America is roughly the same strength, and it is worth knowing which one your lozenge is filed under.
Which monographs turn up on a lozenge
| Identifier | Title | Former CFR part | Products here |
|---|---|---|---|
| M012 | Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use The cough drop monograph. It is the one that sets what a menthol or dextromethorphan lozenge may contain, and its text is still published as 21 CFR 341. | 21 CFR 341 | 449 |
| M022 | Oral Healthcare Drug Products for Over-the-Counter Human Use The monograph most sore throat and mouth pain lozenges are marketed under. Benzocaine, dyclonine, hexylresorcinol, phenol and the oral demulcents sit here rather than in the cough and cold monograph. | None | 97 |
| M001 | Antacid Products for Over-the-Counter Human Use Chewable antacids are listed as chewing gum or as lozenges, so they appear in this dataset even though they act on the stomach rather than the mouth. | 21 CFR 331 | 7 |
| M013 | Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use Cited by the small number of listings whose active ingredient is a systemic pain reliever presented in a lozenge or gum. | 21 CFR 343 | 2 |
Identifiers taken from the application number on each FDA listing, retrieved 4 September 2026. Titles and CFR mappings from FDA's OTC Monographs register and from FDA's own crosswalk table in the Federal Register, both linked at the foot of this page.
There is no 21 CFR 356
Most sore throat lozenges are oral anaesthetics or demulcents, and the obvious place to look for their rules is the oral health care monograph. It is not in the Code of Federal Regulations at all.
There is no 21 CFR part for oral health care drug products. It was proposed as part 356 in 1988 and again in 1994 and never finalised, so the tentative final monograph became a deemed final order under the CARES Act without ever being codified. A citation to 21 CFR 356 is a citation to something that does not exist.
This is worth stating plainly because the citation is easy to find in older writing and looks authoritative. Part 350, 352, 355, 357 and 358 exist. Part 356 does not. A reference that cited it would be citing a proposal that was abandoned.
And 21 CFR 341 is in an odd position too
The cough and cold monograph is codified, published and quotable, and it is the text quoted below. But under section 505G of the Federal Food, Drug, and Cosmetic Act the monographs in force when the CARES Act was enacted in March 2020 became final administrative orders, and FDA has said the regulations will be withdrawn or revised. That has not happened. So part 341 is neither superseded nor the controlling instrument. Both statements are true at the same time, and a reference that picked the tidier one would be wrong.
What the monograph actually says
Seven passages, quoted rather than summarised. The strength limits are the interesting part: they are why a cough drop is the size it is.
What the regulation calls an oral antitussive
(b) Oral antitussive drug. A drug that either is taken by mouth or is dissolved in the mouth in the form of a lozenge and acts systemically to relieve cough.21 CFR 341.3(b)
What the regulation calls a topical antitussive
(c) Topical antitussive drug. A drug that relieves cough when inhaled after being applied topically to the throat or chest in the form of an ointment or from a steam vaporizer, or when dissolved in the mouth in the form of a lozenge for a local effect.21 CFR 341.3(c)
Antitussive active ingredients the monograph permits
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
The permitted strength of a menthol lozenge
(iii) For products containing menthol identified in § 341.14(b)(2) in a lozenge. The product contains 5 to 10 milligrams menthol. Adults and children 2 to under 12 years of age: Allow lozenge to dissolve slowly in the mouth. May be repeated every hour as needed or as directed by a doctor. Children under 2 years of age: Consult a doctor.21 CFR 341.74(d)(2)(iii)
The permitted dose of dextromethorphan
(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)
The warning every cough suppressant label must carry
(1) For oral and topical antitussives. "A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor."21 CFR 341.74(c)(1)
What a cough suppressant must call itself
(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a "cough suppressant" or an "antitussive (cough suppressant)."21 CFR 341.74(a)
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. The source XML. Ellipses mark nothing: each quotation is a complete paragraph as published, trimmed only at its own boundaries.
What this means when you are holding a packet
- A menthol lozenge sold as a cough suppressant contains 5 to 10 mg of menthol. If yours contains 2.7 mg, it is not a weaker cough drop, it is a different kind of product filed under a different monograph.
- "Oral anesthetic" on the Purpose line is a category, not a promise. It means the ingredient numbs the surface it touches.
- A nicotine lozenge is not a monograph product at all. It is filed under an approved drug application, which is a different and more demanding route.
- Unapproved homeopathic in the marketing category means FDA has not reviewed the product for effectiveness before sale.
Each of these is checkable on the relevant page: see menthol, nicotine and zinc gluconate.
Sources
- OTC Monographs@FDAFDA's register of every deemed final and reformed OTC monograph order.
- Final Administrative Orders for Over-the-Counter Monographs; Availability, 86 FR 52474 (21 September 2021)Table 1 is FDA's crosswalk from each monograph identifier to its former CFR part.
- Rulemaking History for OTC Oral Healthcare Drug ProductsFDA's own record that the oral health care monograph was pending as 21 CFR part 356 and never finalised.
- 21 CFR Part 341 on eCFRThe cough and cold monograph as codified, still published.