21 C.F.R. § 341.14

Antitussive active ingredients.

Last amended: 2016Year: 2026Length: 104 wordsSubsections: 3Official source

Cite as 21 C.F.R. § 341.14 (2026)

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. [52 FR 30055, Aug. 12, 1987, as amended at 59 FR 29174, June 3, 1994; 67 FR 4907, Feb. 1, 2002]
Cross-references to the CFR
21:1308.15290.2341.74
21 C.F.R. § 341.14: Antitussive active ingredients. | Justis AI