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 Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N000004-004 PAREDRINE HYDROXYAMPHETAMINE HYDROBROMIDE 1% SOLUTION/DROPS / OPHTHALMIC Approved before 1982
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join First Aid Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Hubei Changjian Medical Products Co., Ltd. 34e8776c-1f36-4e1b-9d71-727591ac904d 2024-10-11 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only. Do not use in the eyes over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor. Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if the condition persists or gets worse. a rash or other allergic reaction develops. Keep out of reach of children. lf swallowed, get medical help or contact a Poison Control Center right away.
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 Identifiers# Field, Values table Field Values Unii 89Y4M234ES, 057Y626693, 19371312D4
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
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