21 CFR § 346.12 - Vasoconstrictor active ingredients.

---
identifier: "/us/cfr/t21/s346.12"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 346.12 - Vasoconstrictor active ingredients."
title_number: 21
title_name: "Food and Drugs"
section_number: "346.12"
section_name: "Vasoconstrictor active ingredients."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "346"
part_name: "ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 351, 352, 353, 355, 360, 371."
regulatory_source: "55 FR 31779, Aug. 3, 1990, unless otherwise noted."
cfr_part: "346"
---


# 346.12 Vasoconstrictor active ingredients.

The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient.

(a) Ephedrine sulfate 0.1 to 1.25 percent.

(b) Epinephrine 0.005 to 0.01 percent.

(c) Epinephrine hydrochloride 0.005 to 0.01 percent.

(d) Phenylephrine hydrochloride 0.25 percent.