Home NDC 80489-412 Drs pharmacy triple antibiotic Pain plus itch plus Scar
Product NDC 80489-412
11-digit product format 804890412
Labeler code 80489
Product ID 80489-412_563671a0-6672-ab59-e063-6294a90a3c4f
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 BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength 500; 3.5; 10000; 10 [USP'U]/g; mg/g; [USP'U]/g; mg/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 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 Pain plus itch plus Scar
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 500 [USP'U]/g NEOMYCIN SULFATE 3.5 mg/g POLYMYXIN B SULFATE 10000 [USP'U]/g PRAMOXINE HYDROCHLORIDE 10 mg/g
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80489-412-01 Drs pharmacy triple antibiotic Pain plus itch plus Scar 1 in 1 CARTON OINTMENT 1 1 80489-412-01 Drs pharmacy triple antibiotic Pain plus itch plus Scar 14 g in 1 TUBE OINTMENT 14 1 80489-412-02 Drs pharmacy triple antibiotic Pain plus itch plus Scar 1 in 1 CARTON OINTMENT 1 1 80489-412-02 Drs pharmacy triple antibiotic Pain plus itch plus Scar 28.3 g in 1 TUBE OINTMENT 28.3 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-412 DRS PHARMACY TRIPLE ANTIBIOTIC PAIN PLUS ITCH PLUS SCAR (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENT) OINTMENT [OL PHARMA TECH, LLC] 1 Current NDC, 4 package rows 20240418_16273878-2f58-0d26-e063-6394a90a47d2.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 44 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 Sample Exclude flag Status 80489-412-01 80489041201 1 TUBE in 1 CARTON (80489-412-01) / 14 g in 1 TUBE 1 tube 2021-02-16 No No Current 80489-412-02 80489041202 1 TUBE in 1 CARTON (80489-412-02) / 28.3 g in 1 TUBE 1 tube 2021-02-16 No No Current