21 C.F.R. § 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.
Notes of Decisions
Cited in 2
cases, 2004–2008 · leading case: Prince v. BF Ascher Co., Inc., 2004 OK CIV APP 39 (Okla. Civ. App. 2004).
Prince v. BF Ascher Co., Inc., 2004 OK CIV APP 39 (Okla. Civ. App. 2004). “21 C.F.R. § 341.20 (b)(9). It classifies Benze-drex® a nonnareotic product that may be sold without a prescription.”
Indep. Cnty. v. Pfizer, Inc., 534 F. Supp. 2d 882 (E.D. Ark. 2008). “(B) Subdivision (a)(l!)(A) of this section does not apply to the transmission of a caller identification service by a telecommunications provider, (b) The deceptive and unconscionable trade practices listed in this section are in addition to and do not limit the types of unfair…”
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