FDA — authorised 19 April 1954
- Application: ANDA060647
- Marketing authorisation holder: DOW PHARM
- Local brand name: NEO-POLYCIN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
🇺🇸 BACITRACIN ZINC in United States
FDA authorised BACITRACIN ZINC on 19 April 1954 · 320 US adverse-event reports
Marketing authorisations
FDA — authorised 10 May 1971
- Application: NDA050417
- Marketing authorisation holder: CASPER PHARMA LLC
- Local brand name: LUMI-SPORYN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 22 January 1981
- Application: ANDA060764
- Marketing authorisation holder: PADAGIS US
- Local brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 26 January 1995
- Application: ANDA064046
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: BACITRACIN ZINC AND POLYMYXIN B SULFATE
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 30 January 1995
- Application: ANDA064028
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: BACITRACIN ZINC AND POLYMYXIN B SULFATE
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 30 October 1995
- Application: ANDA064064
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 30 October 1995
- Application: ANDA064068
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 27 February 2002
- Application: ANDA065022
- Marketing authorisation holder: PADAGIS US
- Local brand name: BACITRACIN ZINC AND POLYMYXIN B SULFATE
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 6 February 2004
- Application: ANDA065088
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA062386
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA062167
- Marketing authorisation holder: PHARMADERM
- Local brand name: BACITRACIN-NEOMYCIN-POLYMYXIN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA062381
- Marketing authorisation holder: PHARMAFAIR
- Local brand name: NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA
- Application: ANDA062499
- Marketing authorisation holder: COMBE
- Local brand name: LANABIOTIC
- Indication: OINTMENT — TOPICAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 320
Most-reported reactions
- Drug Hypersensitivity — 59 reports (18.44%)
- Rash — 35 reports (10.94%)
- Off Label Use — 34 reports (10.62%)
- Nausea — 31 reports (9.69%)
- Headache — 29 reports (9.06%)
- Drug Ineffective — 28 reports (8.75%)
- Fatigue — 28 reports (8.75%)
- Pruritus — 27 reports (8.44%)
- Pain — 25 reports (7.81%)
- Diarrhoea — 24 reports (7.5%)
BACITRACIN ZINC in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is BACITRACIN ZINC approved in United States?
Yes. FDA authorised it on 19 April 1954; FDA authorised it on 10 May 1971; FDA authorised it on 22 January 1981.
Who is the marketing authorisation holder for BACITRACIN ZINC in United States?
DOW PHARM holds the US marketing authorisation.