Is Benzoyl peroxide + Erythromycin approved by the US FDA?

Drugs@FDA lists 4 application product lines for Benzoyl peroxide + Erythromycin, including BENZAMYCIN (Prescription); ERYTHROMYCIN AND BENZOYL PEROXIDE (Prescription); AKTIPAK (Discontinued); ERYTHROMYCIN AND BENZOYL PEROXIDE (Discontinued).

Active substances

Benzoyl peroxide + Erythromycin

US FDA 4
Health Canada 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
BENZAMYCIN	5%;3%	gel · topical	VALEANT INTL	Prescription	26 Oct 1984
ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	gel · topical	RISING	Prescription	18 Sep 2015
AKTIPAK	5%;3%	gel · topical	BIOFRONTERA	Discontinued	27 Nov 2000
ERYTHROMYCIN AND BENZOYL PEROXIDE	5%;3%	gel · topical	ENCUBE	Discontinued	29 Mar 2004

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BENZAMYCIN	02225271	5 % / W/W; 3 % / W/W	GEL · TOPICAL	BAUSCH HEALTH, CANADA INC.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.