C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 341—COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE › Subpart B—Active Ingredients

21 C.F.R. § 341.14

Antitussive active ingredients

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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]
Notes of Decisions
Cited in 5 cases (2 in the last 5 years), 1989–2025 · leading case: Sandoz Pharm. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990).
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Sandoz Pharm. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990). “Demulcents have not been classified as inactive or active by the Food and Drug Administration, see 21 C.F.R. § 341.14 (1988) (not including demulcents in an approved list of antitus-sives); 41 Fed.”
Sandoz Pharm. Corp. v. Richardson-Vicks, Inc., 735 F. Supp. 597 (D. Del. 1989). “See 21 C.F.R. § 341.14 (giving list of antitussive active ingredients).”
Tobin v. Procter & Gamble Co., No. 4:23-cv-05061, 2024 WL 1560050 (N.D. Cal. Apr. 9, 2024). “See 21 C.F.R. § 341.14 (identifying menthol, but not 22 honey, among active ingredients).”
Al Haj v. Pfizer Inc, No. 1:17-cv-06730, 2019 WL 3202807 (N.D. Ill. July 16, 2019). “at ¶¶ 6, 13; 21 C.F.R. §§ 341.14 (a)(4) (DXM Hbr), 341.”
Taylor v. Reckitt Benckiser Pharm., Inc., No. 1:23-cv-08783 (E.D.N.Y. Jan. 31, 2025). “(citing 21 C.F.R. §§ 341.14 , 341.18, 341.20).) allegedly misleading statement in light of its context on the product label or advertisement as a whole.”
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