21 C.F.R. § 341.14
Antitussive active ingredients.
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