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_5d41a879-712e-ebe9-e063-6294a90a554c
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 2027-12-31
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 Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 400 [iU]/g NEOMYCIN SULFATE 5 mg/g POLYMYXIN B SULFATE 5000 [iU]/g
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
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 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