Home NDC 80489-919-01 Drs. Pharmacy Triple Antibiotic AND BURN RELIEF
Product NDC 80489-919
Requested package NDC 80489-919-01
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 102 of 114 · 2,277 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join STRAWBERRY SHORTCAKE SCENTED HAND SANITIZER ALCOHOL Ganzhou Olivee Cosmetic Co., Ltd. 997d0ff0-96b4-4b91-87fc-8f67d9b5013c 2024-08-28 Warnings Exact identifier application number: M003 hand sanitizer 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. 202dfeac-6e69-8667-e063-6294a90a26d2 2024-08-21 Warnings Exact identifier application number: M003 antibacterial hand sanitizer gel 01 ALCOHOL Cosmuses Cosmetics (Ningbo) Co., Ltd. 202e5c15-8749-0a76-e063-6294a90a2720 2024-08-21 Warnings Exact identifier application number: M003 Be Smart Get Prepared Burn Cream BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS Total Resources International, Inc eacb5138-4af8-4550-b883-5603ad96ed7d 2024-08-16 Warnings Exact identifier application number: M003 First Aid Only Povidone-Iodine Antiseptic POVIDONE-IODINE Acme United Corporation e0052ac2-4f74-32a4-e053-2995a90a94c6 2024-08-13 Warnings Exact identifier application number: M003 Keep Going Sting Relief Pad BENZOCAINE AND ISOPROPYL ALCOHOL JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 36c11178-b70f-4355-8823-c2b72598dae5 2024-08-08 Warnings Exact identifier application number: M003 Keep Going Non Sting Cleaning Wipe BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 6b7400d5-d4b8-4b68-b048-c1917cdf3ce3 2024-08-08 Warnings Exact identifier application number: M003 Keep Going Alcohol Prep Pad ISOPROPYL ALCOHOL JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. f67dd10c-746f-4c21-92f1-741f86218a69 2024-08-08 Warnings Exact identifier application number: M003 Sugar Cookie Sanitizer 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1efc0e9e-b4eb-d2b0-e063-6394a90a7779 2024-08-06 Warnings Exact identifier application number: M003 Lemon Lime Hand Sanitizer Spray. 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1efe7236-d7bd-2a1c-e063-6294a90a736e 2024-08-06 Warnings Exact identifier application number: M003 Maokang Medical 10 Povidone Iodine POVIDONE-IODINE Changzhou Maokang Medical Products Co., Ltd 644e92c3-3043-4a76-9845-7e0482cf9f62 2024-07-19 Warnings Exact identifier application number: M003 Dermal Wound Cleanser BENZETHONIUM CHLORIDE Smith & Nephew Medical Ltd. 18704cd5-1ecf-4e8c-9897-7e45394e68c8 2024-07-15 Warnings Exact identifier application number: M003 Novex Anti-Bacterial Hand Sanitizer Wipe BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 7832a0be-a8ce-4b56-a9bb-a375b97df287 2024-07-10 Warnings Exact identifier application number: M003 Callington Anti-Bacterial Hand Sanitizer Wipe BENZALKONIUM CHLORIDE JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD. 00ca48ca-893d-4a3f-ad90-119522664e08 2024-07-10 Warnings Exact identifier application number: M003 Assorted Licensed Hand Sanitizer Grape 01 ALCOHOL Shenzhen Lantern Scicence Co.,Ltd. 1c9095ad-ce19-3666-e063-6394a90ae22d 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS ETHYL ALCOHOL MY IMPORTS USA LLC 1ccb78ed-36f9-a7d2-e063-6394a90a6477 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER ETHYL ALCOHOL MY IMPORTS USA LLC 1ccb9671-1970-39f9-e063-6294a90ac079 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY ETHYL ALCOHOL MY IMPORTS USA LLC 1ccbc68e-2b6b-768c-e063-6294a90a643b 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL ETHYL ALCOHOL MY IMPORTS USA LLC 1ccbbc55-3f7d-76d1-e063-6294a90a5590 2024-07-09 Warnings Exact identifier application number: M003 AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER ETHYL ALCOHOL Zhejiang Guoyao Jingyue Aerosol Co., Ltd. 1cb701f7-61c8-e5f4-e063-6294a90a0c3c 2024-07-08 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