Menthol
Monograph active ingredient
Menthol
Topical antitussive under FDA monograph M012. Its permitted strength and indication are set by 21 CFR 341 and quoted here from the regulation.
What the monograph permits
Every figure below is the regulation's own sentence, quoted rather than summarised, with the paragraph it comes from.
Lozenge — 5 to 10 mg per 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)
Suitable ointment vehicle — 2.6 to 2.8 %
(ii) For products containing menthol identified in § 341.14(b)(2) in a suitable ointment vehicle. The product contains 2.6 to 2.8 percent menthol. "[bullet] see important warnings under 'When using this product' " [appears as the first statement under the heading "Directions" and is highlighted in bold type] [bullet] adults and children 2 years and older: [bullet] rub on the throat and chest in a thick layer [bullet] cover with a warm, dry cloth if desired [bullet] clothing should be loose about throat and chest to help vapors reach the nose and mouth [bullet] use up to three times daily or as directed by a doctor [bullet] children under 2 years of age: Ask a doctor.21 CFR 341.74(d)(2)(ii)
21 CFR 341, 2025 annual edition, retrieved from govinfo on 9 September 2026. How the monograph system works.
What the label may say
The monograph fixes both what the product must call itself and the indication wording it may use. These are the permitted phrases, verbatim; a product may not claim more than this.
Statement of identity
(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)
Permitted indication
(2) "Temporarily" (select one of the following: "alleviates," "calms," "controls," "decreases," "quiets," "reduces," "relieves," or "suppresses") "cough" (select one of the following: "as may occur with," "associated with," or "occurring with") (select one of the following: "A cold," "the common cold," or "inhaled irritants").21 CFR 341.74(b)(2)
The warning the 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)
Menthol is the only active ingredient the CFR gives a codified per-lozenge strength: 5 to 10 mg in a lozenge marketed as a cough suppressant. A menthol lozenge outside that range is not a weaker or stronger cough drop, it is a different kind of product, most often an oral anaesthetic filed under the oral health care monograph, where menthol also appears as an oral analgesic that the CFR does not codify. This page reports only the codified cough-suppressant use.
On the shelf
461 FDA-listed products in a lozenge, pastille, troche or gum contain menthol. What they weigh, who makes them and how they are marketed is on the Menthol product page, which is built from the FDA National Drug Code Directory rather than from the monograph.
This page reports what the FDA monograph permits, not what you should take. It is not medical advice, and it makes no claim that menthol is effective for any condition. Always follow the product label, and ask a pharmacist or a doctor.
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.