Home NDC 69396-037 Family Wellness First Aid Antibiotic
Product NDC 69396-037
11-digit product format 693960037
Labeler code 69396
Product ID 69396-037_298d8c06-7975-7cc0-e063-6394a90a3e43
Type HUMAN OTC DRUG
Nonproprietary name Family Wellness bacitracin zinc, polymyxin B sulfate
Dosage form OINTMENT
Route TOPICAL
Labeler Trifecta Pharmaceuticals USA, LLC
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-08-29
Substance POLYMYXIN B SULFATE; BACITRACIN ZINC
Active strength 10000; 500 [USP'U]/g; [USP'U]/g
Pharmacologic classes 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 Family Wellness First Aid Antibiotic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYMYXIN B SULFATE 10000 [USP'U]/g BACITRACIN ZINC 500 [USP'U]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 19371312D4 Internal UNII lookup 89Y4M234ES Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308512 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 69396-037-04 Family Wellness First Aid Antibiotic 1 in 1 BOX OINTMENT 1 9 69396-037-04 Family Wellness First Aid Antibiotic 14.2 g in 1 TUBE OINTMENT 14.2 9 69396-037-05 Family Wellness First Aid Antibiotic 15 g in 1 TUBE OINTMENT 15 9 69396-037-05 Family Wellness First Aid Antibiotic 1 in 1 BOX OINTMENT 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69396-037 FAMILY WELLNESS FIRST AID ANTIBIOTIC (FAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATE) OINTMENT [TRIFECTA PHARMACEUTICALS USA, LLC] 9 Current NDC, Legacy NDC, 4 package rows 20241220_9157681a-3ed1-096e-e053-2a95a90a05e3.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 Marketing end Sample Exclude flag Status 69396-037-04 69396003704 1 TUBE in 1 BOX (69396-037-04) / 14.2 g in 1 TUBE 1 tube 2020-01-10 0000-00-00 No No Current 69396-037-05 69396003705 1 TUBE in 1 BOX (69396-037-05) / 15 g in 1 TUBE 1 tube 2019-08-30 0000-00-00 No No Current