Active ingredient
Menthol, Unspecified Form
35 products in the FDA listing contain Menthol, Unspecified Form, at strengths from 2.5 to 7.6 mg.
A listing that names menthol without specifying which form. FDA keeps it as a distinct substance record.
This is a labelling choice by the company filing the listing, not a different ingredient in the box.
FDA records these as separate substances
Strengths actually on the market
| Strength | Unit | Products | Share |
|---|---|---|---|
| 2.5 | mg per unit | 6 | 17% |
| 5 | mg per unit | 6 | 17% |
| 5.8 | mg per unit | 6 | 17% |
| 6 | mg per unit | 4 | 11% |
| 7.6 | mg per unit | 4 | 11% |
| 7 | mg per unit | 3 | 9% |
| 5.4 | mg per unit | 2 | 6% |
| 2.6 | mg per unit | 1 | 3% |
Counted from the 35 listings on this page. Share is of all products containing Menthol, Unspecified Form, 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.
All units in the listing
| Unit | Range | Listings |
|---|---|---|
| mg per unit | 2.5 to 7.6 mg | 29 |
| mg / 4.2 g | 5 to 6 mg / 4.2 g | 3 |
| g / 1 g | 0.7 to 0.86 g / 1 g | 2 |
| mg / 100 mg | 7.6 mg / 100 mg | 1 |
What the monograph says
These are the passages of 21 CFR 341 that name menthol 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 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)
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 |
|---|---|
| Sore throat | 30 |
| Cough | 26 |
| Minor throat irritation | 24 |
| Sore mouth, gums and canker sores | 17 |
| Common cold symptoms | 7 |
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.
Menthol, Unspecified Form products on Amazon
Affiliate linksAmazon listings returned for "Menthol, Unspecified Form lozenge". They are in Amazon's own search order and are not ranked, selected or endorsed by this site. Check the strength on the package against the table above.
As an Amazon Associate we earn from qualifying purchases, at no extra cost to you. These listings come from Amazon's catalogue in its own search order. No manufacturer pays for a place here, and nothing about a product's entry on this site depends on whether it can be bought. Prices were retrieved on 4 September 2026 and will have changed; the price on Amazon when you buy is the one that applies. This is not a recommendation for any condition.
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.
