Home NDC 51316-044-01 Antibiotic
Product NDC 51316-044
Requested package NDC 51316-044-01
11-digit product format 513160044
Labeler code 51316
Product ID 51316-044_50187929-7372-4b3d-939d-d13be4dc4b51
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin Zinc, Polymyxin B Sulfate
Dosage form OINTMENT
Route TOPICAL
Labeler CVS PHARMACY, INC
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-25
Substance BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength 500; 10000 [iU]/g; [iU]/g
Pharmacologic classes 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 Antibiotic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 500 [iU]/g POLYMYXIN B SULFATE 10000 [iU]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 89Y4M234ES Internal UNII lookup 19371312D4 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 51316-044-01 Antibiotic 28 g in 1 TUBE OINTMENT 28 3 51316-044-01 Antibiotic 1 in 1 CARTON OINTMENT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-044 ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) OINTMENT [CVS PHARMACY, INC] 3 Current NDC, Legacy NDC, 2 package rows 20240316_32e92acf-2e48-4933-8e08-e1df650e7d19.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 51316-044-01 51316004401 1 TUBE in 1 CARTON (51316-044-01) / 28 g in 1 TUBE 1 tube 2022-02-25 0000-00-00 No No Current