The rule layer

What the monograph permits

The ingredient pages answer what is in the products on the shelf. This answers the prior question: what an active ingredient is allowed to be. Each row is a substance the FDA OTC monograph permits in a lozenge, with the strength and the indication wording the regulation sets, quoted rather than paraphrased. Where the monograph is not written into the Code of Federal Regulations, the honest entry is that there is no strength to quote.

permitted active ingredients

with a strength codified in 21 CFR 341

under a monograph the CFR does not codify

actually present in a listed product

Two of these ingredients are not the same claim. A codified active has a strength you can read in the regulation. An uncodified one is governed by the oral health care monograph (M022), which was proposed as 21 CFR part 356 and never finalised, so there is no CFR text and this site prints no strength range for it rather than inventing one. Which is which is marked in every table below.

Antitussive

Active ingredient	Monograph category	Permitted strength	Source	On the shelf
Menthol	Topical antitussive	5 to 10 mg per lozenge	21 CFR 341	461
Dextromethorphan	Oral antitussive	10 to 20 mg per dose	21 CFR 341	16
Chlophedianol hydrochloride	Oral antitussive	25 mg per dose	21 CFR 341	None
Diphenhydramine citrate	Oral antitussive	38 mg per dose	21 CFR 341	None
Diphenhydramine hydrochloride	Oral antitussive	25 mg per dose	21 CFR 341	None
Codeine	Oral antitussive (combination only)	10 to 20 mg per dose	21 CFR 341	None
Camphor	Topical antitussive	4.7 to 5.3 %	21 CFR 341	None

Expectorant

Active ingredient	Monograph category	Permitted strength	Source	On the shelf
Guaifenesin	Expectorant	200 to 400 mg per dose	21 CFR 341	None

Oral anesthetic/analgesic

Active ingredient	Monograph category	Permitted strength	Source	On the shelf
Benzocaine	Oral anesthetic/analgesic	Not codified	M022	36
Dyclonine hydrochloride	Oral anesthetic/analgesic	Not codified	M022	3
Hexylresorcinol	Oral anesthetic/analgesic	Not codified	M022	4
Phenol	Oral anesthetic/analgesic	Not codified	M022	None

Oral demulcent

Active ingredient	Monograph category	Permitted strength	Source	On the shelf
Pectin	Oral demulcent	Not codified	M022	52

Codified strengths and indication wording are quoted from 21 CFR 341, 2025 annual edition, retrieved from govinfo on 9 September 2026. Monograph categories for the oral health care actives follow FDA's OTC monograph register; see the rules explained. The "on the shelf" count is the number of FDA-listed lozenges, pastilles, troches and gums that contain the ingredient, from the National Drug Code Directory. 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.

When the listing changes

An occasional email, sent when this site is rebuilt from a new FDA pull: what changed in the National Drug Code listing, which products were added or withdrawn, and any correction made here. It goes out when the data moves rather than on a schedule. It is not medical advice, it does not recommend products, and it will not tell you what to take.