Home NDC 69396-138 First Aid Antibiotic plus Burn Relief
Product NDC 69396-138
11-digit product format 693960138
Labeler code 69396
Product ID 69396-138_298dae2b-f42d-53a1-e063-6394a90a223b
Type HUMAN OTC DRUG
Nonproprietary name Bacitracinzinc,NeomycinSulfate,PolymxinBSulfate,PramoxineHCI
Dosage form OINTMENT
Route TOPICAL
Labeler Trifecta Pharmaceuticals USA LLC
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-09-04
Substance PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE; BACITRACIN ZINC; NEOMYCIN SULFATE
Active strength 10; 10000; 500; 3.5 mg/g; [USP'U]/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 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 First Aid Antibiotic plus Burn Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 10 mg/g POLYMYXIN B SULFATE 10000 [USP'U]/g BACITRACIN ZINC 500 [USP'U]/g NEOMYCIN SULFATE 3.5 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69396-138-02 First Aid Antibiotic plus Burn Relief 57 g in 1 TUBE OINTMENT 57 2 69396-138-02 First Aid Antibiotic plus Burn Relief 1 in 1 BOX OINTMENT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-138 FIRST AID ANTIBIOTIC PLUS BURN RELIEF (BACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCI) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC] 2 Current NDC, 2 package rows 20241220_048871e2-c917-292d-e063-6394a90af130.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 22 of 22 · 424 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Family Wellness Antiseptic and Pain Relief BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE FRONT PHARMACEUTICAL PLC cb7fdcde-2bd8-4834-ba4e-4d6fd1512599 2023-10-26 Warnings Exact identifier application number: M004 GENUINE FIRST AID Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Nantong Health & Beyond Hygienic Products Inc. 23abfe12-5b50-4b49-878e-4fcdb6c341fd 2023-10-19 Warnings Exact identifier application number: M004 EVERLIT CARE Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Nantong Health & Beyond Hygienic Products Inc. f4921508-c32f-426f-a2f0-16c3acbd4713 2023-10-14 Warnings Exact identifier application number: M004 Cuadriderma BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE ProMex LLC 4fa99b96-ab4b-4523-82bc-343dbaf39fb6 2022-01-25 Warnings Exact identifier application number: M004
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69396-138-02 69396013802 1 TUBE in 1 BOX (69396-138-02) / 57 g in 1 TUBE 1 tube 2023-09-04 No No Current