Home NDC 61010-5601 Single Antibiotic with bacitracin
Product NDC 61010-5601
11-digit product format 610105601
Labeler code 61010
Product ID 61010-5601_55135000-91eb-c54b-e063-6394a90afdcd
Type HUMAN OTC DRUG
Nonproprietary name bacitracin zinc
Dosage form OINTMENT
Route TOPICAL
Labeler Safetec of America
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-11-13
Substance BACITRACIN ZINC
Active strength 400 [USP'U]/g
Pharmacologic classes Decreased Cell Wall Synthesis & Repair [PE]
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 Single Antibiotic with bacitracin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 400 [USP'U]/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 89Y4M234ES Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 61010-5601-2 2024-02-13 61010-5601, Single antibiotic with Bacitracin 61010-5601-2 2024-02-13 61010-5601, Single antibiotic with Bacitracin 61010-5601-3 2024-02-13 61010-5601, Single antibiotic with Bacitracin 61010-5601-3 2024-02-13 61010-5601, Single antibiotic with Bacitracin 61010-5601-2 2024-01-30 61010-5601, Single antibiotic with Bacitracin 61010-5601-2 2024-01-30 61010-5601, Single antibiotic with Bacitracin 61010-5601-3 2024-01-30 61010-5601, Single antibiotic with Bacitracin 61010-5601-3 2024-01-30 61010-5601, Single antibiotic with Bacitracin
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61010-5601-1 Single Antibiotic with bacitracin 0.9 g in 1 POUCH OINTMENT 0.9 5 61010-5601-2 Single Antibiotic with bacitracin 144 in 1 BOX OINTMENT 144 5 61010-5601-3 Single Antibiotic with bacitracin 25 in 1 BOX OINTMENT 25 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61010-5601 SINGLE ANTIBIOTIC WITH BACITRACIN (BACITRACIN ZINC) OINTMENT [SAFETEC OF AMERICA] 5 Current NDC, Legacy NDC, 3 package rows 20240215_4ae9a105-e3f9-4015-8844-085e0b34cdb6.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 Units Marketing start Marketing end Sample Exclude flag Status 61010-5601-1 61010560101 0.9 g in 1 POUCH 0.9 g Historical 61010-5601-2 61010560102 144 POUCH in 1 BOX (61010-5601-2) / .9 g in 1 POUCH (61010-5601-1) 144 pouch 2008-11-13 0000-00-00 No No Current 61010-5601-3 61010560103 25 POUCH in 1 BOX (61010-5601-3) / .9 g in 1 POUCH (61010-5601-1) 25 pouch 2008-11-13 0000-00-00 No No Current