Home NDC 82996-001 First Aid Antibiotic
Product NDC 82996-001
11-digit product format 829960001
Labeler code 82996
Product ID 82996-001_2434694e-cf1d-49bc-e063-6294a90a05d3
Type HUMAN OTC DRUG
Nonproprietary name BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Dosage form GEL
Route TOPICAL
Labeler Hubei Changjian Medical Products Co., Ltd.
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-01
Marketing end 2027-04-01
Substance BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength 400; 35; 5000 [iU]/g; mg/g; [iU]/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
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 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 400 [iU]/g NEOMYCIN SULFATE 35 mg/g POLYMYXIN B SULFATE 5000 [iU]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 89Y4M234ES Internal UNII lookup 057Y626693 Internal UNII lookup 19371312D4 Internal UNII 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 82996-001-01 First Aid Antibiotic 0.5 g in 1 POUCH GEL 0.5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82996-001 FIRST AID ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) GEL [HUBEI CHANGJIAN MEDICAL PRODUCTS CO., LTD.] 4 Current NDC, Legacy NDC, 1 package rows 20241013_34e8776c-1f36-4e1b-9d71-727591ac904d.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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 82996-001-01 82996000101 .5 g in 1 POUCH (82996-001-01) 2022-11-01 2027-04-01 No No Current