21 CFR 341.20 - Nasal decongestant active ingredients.

Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

View all text of Subpart B [§ 341.12 - § 341.40]

§ 341.20 - Nasal decongestant active ingredients.

The active ingredient of the product consists of any of the following when used within the dosage limits and in the dosage forms established for each ingredient:

(a) Oral nasal decongestants. (1) Phenylephrine hydrochloride.

(2) Pseudoephedrine hydrochloride.

(3) Pseudoephedrine sulfate.

(4) Phenylephrine bitartrate in an effervescent dosage form.

(b) Topical nasal decongestants. (1) Levmetamfetamine.

(2) Ephedrine.

(3) Ephedrine hydrochloride.

(4) Ephedrine sulfate.

(5) [Reserved]

(6) Naphazoline hydrochloride.

(7) Oxymetazoline hydrochloride.

(8) Phenylephrine hydrochloride.

(9) Propylhexedrine.

(10) Xylometazoline hydrochloride.

[59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998; 71 FR 43362, Aug. 1, 2006]

authority: 21 U.S.C. 321,351,352,353,355,360,371

cite as: 21 CFR 341.20