Home NDC 80489-919 Drs. Pharmacy Triple Antibiotic AND BURN RELIEF
Product NDC 80489-919
11-digit product format 804890919
Labeler code 80489
Product ID 80489-919_4928d0c5-0313-dfd6-e063-6394a90ab798
Type HUMAN OTC DRUG
Nonproprietary name bacitracin zinc, neomycin sulfate, polymyxin b sulfate
Dosage form OINTMENT
Route TOPICAL
Labeler OL PHARMA TECH, LLC Drs PHARMACY
Application M003
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-05
Substance BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength 500; 3.5; 10000; 10 [USP'U]/1000mg; mg/1000mg; [USP'U]/1000mg; mg/1000mg
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 2027-12-31
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 AND BURN RELIEF
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 500 [USP'U]/1000mg NEOMYCIN SULFATE 3.5 mg/1000mg POLYMYXIN B SULFATE 10000 [USP'U]/1000mg PRAMOXINE HYDROCHLORIDE 10 mg/1000mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1359350 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 80489-919-01 Drs. Pharmacy Triple Antibiotic AND BURN RELIEF 14000 mg in 1 TUBE OINTMENT 14000 1 80489-919-01 Drs. Pharmacy Triple Antibiotic AND BURN RELIEF 1 in 1 CARTON OINTMENT 1 1 80489-919-02 Drs. Pharmacy Triple Antibiotic AND BURN RELIEF 28300 mg in 1 TUBE OINTMENT 28300 1 80489-919-02 Drs. Pharmacy Triple Antibiotic AND BURN RELIEF 1 in 1 CARTON OINTMENT 1 1
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 12 of 115 · 2,286 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink Sugar ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 55fd1844-bfeb-c0ef-e063-6294a90a4492 2026-07-06 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing Spray, Sugared Plum ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 559a9300-964e-ea9a-e063-6394a90a4016 2026-07-02 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Sea Salt Air ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 559a5f07-1557-c6d6-e063-6394a90a832f 2026-07-02 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber Glow ETHYL ALCOHOL 70% V/V Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 55242d92-04af-0224-e063-6394a90aee98 2026-07-02 Warnings Exact identifier application number: M003 BAK 1 750 BENZALKONIUM CHLORIDE Medical Chemical Corporation d1f06aa6-2264-4ac1-a9a4-8ca9be1c9ca8 2026-07-02 Warnings Exact identifier application number: M003 HYDROGEN PEROXIDE HYDROGEN PEROXIDE Medical Chemical Corporation b1ce5858-36fe-70dc-e053-2995a90a5913 2026-07-02 Warnings Exact identifier application number: M003 HYDROGEN PEROXIDE HYDROGEN PEROXIDE Medical Chemical Corporation f6d677b8-fa89-4efb-984a-fd98e3e590e8 2026-07-02 Warnings Exact identifier application number: M003 American Red Cross IPA 50% 6oz AMERICAN RED CROSS IPA 50% 6OZ TSM BRANDS LLC 29195bac-b096-ab8d-e063-6394a90a424a 2026-07-01 Warnings Exact identifier application number: M003 American Red Cross 6oz, 50% Isopropyl Alcohol AMERICAN RED CROSS 6 OZ, 50% ISOPROPYL ALCOHOL SPRAY MY IMPORTS USA LLC 2929d580-cfff-e2b6-e063-6394a90a79aa 2026-07-01 Warnings Exact identifier application number: M003 Medi Fect Antiseptic Hand Wash ETHYL ALCOHOL Medical Chemical Corporation dc397d9c-9c12-41e5-ab7f-196fcad5bf97 2026-07-01 Warnings Exact identifier application number: M003 AloeSafe Antiseptic Hand Sanitizer ETHYL ALCOHOL Medical Chemical Corporation 950f012e-7908-523c-e053-2995a90afa6b 2026-07-01 Warnings Exact identifier application number: M003 Compound Benzoin Tincture TINCTURE OF BENZOIN Medical Chemical Corporation 243494ee-342d-4c32-9a86-f8c6c347bd8b 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach Sandalwood ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 55984504-188f-13bc-e063-6394a90a9150 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber Glow ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 5597ed5f-ed98-ebeb-e063-6294a90a2e8d 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry Creme ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 5598c831-3986-00a5-e063-6394a90a1e66 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Apple Splash ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 55982f73-7baa-26a7-e063-6394a90ab74b 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry Crumble ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 55981d2a-d4de-af08-e063-6294a90a4b7c 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti Cupcake ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 5597ff1f-b134-0beb-e063-6394a90a39a1 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Gingerbread Cake ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 5598d6ca-39f6-ca2a-e063-6394a90abc0e 2026-07-01 Warnings Exact identifier application number: M003 Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Matcha Mist ETHYL ALCOHOL 70% V/V MY IMPORTS USA LLC 559832ca-df92-0c2d-e063-6294a90ab66f 2026-07-01 Warnings Exact identifier application number: M003
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80489-919-01 80489091901 1 TUBE in 1 CARTON (80489-919-01) / 14000 mg in 1 TUBE 1 tube 2021-09-05 No No Current 80489-919-02 80489091902 1 TUBE in 1 CARTON (80489-919-02) / 28300 mg in 1 TUBE 1 tube 2021-09-05 No No Current