Regulatory PathRegulatory requirements compared

Active substances

Bacitracin zinc + Polymyxin b

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMointment · ophthalmicBAUSCH AND LOMB INCPrescription26 Jan 1995
POLYSPORIN500 UNITS/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**ointment · ophthalmicMONARCH PHARMSDiscontinued16 Apr 1974
BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMointment · ophthalmicSCIEGEN PHARMSDiscontinued30 Jan 1995
BACITRACIN ZINC AND POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMointment · ophthalmicPADAGIS USDiscontinued27 Feb 2002
OCUMYCIN500 UNITS/GM;10,000 UNITS/GMointment · ophthalmicPHARMAFAIRDiscontinued
BACITRACIN ZINC-POLYMYXIN B SULFATE500 UNITS/GM;10,000 UNITS/GMointment · topicalNASKADiscontinued
POLYSPORIN10,000 UNITS/GM;2,000,000 UNITS/GMaerosol · topicalGLAXOSMITHKLINEDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ANTIBIOTIC OINTMENT USP02230251500 UNIT / G; 10000 UNIT / GOINTMENT · TOPICALTARO PHARMACEUTICALS INC
BAND-AID BRAND ADHESIVE BANDAGES PLUS ANTIBIOTIC02236954500 UNIT / G; 10000 UNIT / GPAD; OINTMENT · TOPICALKENVUE CANADA INC.
POLYDERM OINTMENT USP02181908500 UNIT / G; 10000 UNIT / GOINTMENT · TOPICALTARO PHARMACEUTICALS INC
POLYSPORIN ANTIBIOTIC OINTMENT02237227500 UNIT / G; 10000 UNIT / GOINTMENT · TOPICALKENVUE CANADA INC.
STERISPORIN0235992810000 UNIT / G; 500 UNIT / GOINTMENT · OPHTHALMICSTERI-MED PHARMA 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.