§341.20. Nasal decongestant active ingredients.
21 C.F.R. § 341.20
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:
Oral nasal decongestants.
Phenylephrine hydrochloride.
Pseudoephedrine hydrochloride.
Pseudoephedrine sulfate.
Phenylephrine bitartrate in an effervescent dosage form.
Topical nasal decongestants.
Levmetamfetamine.
Ephedrine.
Ephedrine hydrochloride.
Ephedrine sulfate.
[Reserved]
Naphazoline hydrochloride.
Oxymetazoline hydrochloride.
Phenylephrine hydrochloride.
Propylhexedrine.
Xylometazoline hydrochloride.
Notes, amendments, and revision history
Amendments
[59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998; 71 FR 43362, Aug. 1, 2006]
Authority
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
Amendments
[59 FR 43409, Aug. 23, 1994, as amended at 63 FR 40650, July 30, 1998; 71 FR 43362, Aug. 1, 2006]