Home NDC 80489-012 Drs. pharmacy triple antibiotic
Product NDC 80489-012
11-digit product format 804890012
Labeler code 80489
Product ID 80489-012_2b51ff20-db0e-8b5d-e063-6294a90a88d0
Type HUMAN OTC DRUG
Nonproprietary name bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
Dosage form OINTMENT
Route TOPICAL
Labeler OL PHARMA TECH, LLC
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-16
Substance NEOMYCIN SULFATE; BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength 3.5; 400; 5000 mg/g; [USP'U]/g; [USP'U]/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Drs. pharmacy triple antibiotic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEOMYCIN SULFATE 3.5 mg/g BACITRACIN ZINC 400 [USP'U]/g POLYMYXIN B SULFATE 5000 [USP'U]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 057Y626693 Internal UNII lookup 89Y4M234ES Internal UNII lookup 19371312D4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204602 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80489-012-01 Drs. pharmacy triple antibiotic 1 in 1 CARTON OINTMENT 1 4 80489-012-01 Drs. pharmacy triple antibiotic 14 g in 1 TUBE OINTMENT 14 4 80489-012-02 Drs. pharmacy triple antibiotic 1 in 1 CARTON OINTMENT 1 4 80489-012-02 Drs. pharmacy triple antibiotic 28.3 g in 1 TUBE OINTMENT 28.3 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-012 DRS. PHARMACY TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT) OINTMENT [OL PHARMA TECH, LLC] 4 Current NDC, Legacy NDC, 4 package rows 20250112_bb730976-0045-c0ae-e053-2a95a90af34e.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 9 of 115 · 2,286 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80489-012-01 80489001201 1 TUBE in 1 CARTON (80489-012-01) / 14 g in 1 TUBE 1 tube 2021-02-16 0000-00-00 No No Current 80489-012-02 80489001202 1 TUBE in 1 CARTON (80489-012-02) / 28.3 g in 1 TUBE 1 tube 2021-02-16 0000-00-00 No No Current