Home NDC 0404-0167 Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Product NDC 0404-0167
11-digit product format 004040167
Labeler code 0404
Product ID 0404-0167_446e48e8-d3d2-e6e0-e063-6394a90ad444
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Dosage form OINTMENT
Route TOPICAL
Labeler Henry Schein
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-03
Substance BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength 400; 5; 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
Listing certified through 2026-12-31
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.
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 or 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, or 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 If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Additional Listing Data#
Finished product Yes
Brand name base Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 400 [iU]/g NEOMYCIN SULFATE 5 mg/g POLYMYXIN B SULFATE 5000 [iU]/g
Harmonized Identifiers# Field, Values table Field Values Unii 89Y4M234ES, 057Y626693, 19371312D4 Rxcui 204602
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 0404-0167-50 Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate 144 in 1 BOX OINTMENT 144 4 0404-0167-50 Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate 1728 in 1 CASE OINTMENT 1728 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-0167 BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE OINTMENT [HENRY SCHEIN] 3 Current NDC, Legacy NDC, 2 package rows 20241129_ead9496b-112e-59e6-e053-2995a90a768c.zip
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 0404-0167-50 00404016750 1728 BOX in 1 CASE (0404-0167-50) / 144 PACKET in 1 BOX / .9 g in 1 PACKET 1728 box 2022-11-03 0000-00-00 No No Current