Home NDC 0713-0280 Bacitracin
Product NDC 0713-0280
11-digit product format 007130280
Labeler code 0713
Product ID 0713-0280_0cee4d1f-c118-adbd-e063-6294a90a74d8
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin
Dosage form OINTMENT
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 1995-01-10
Substance BACITRACIN
Active strength 500 [USP'U]/g
Pharmacologic classes Decreased Cell Wall Synthesis & Repair [PE]
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 • if you are allergic to any of the ingredients • in the eyes • over large areas of the body • longer than 1 week unless directed by a doctor Ask a doctor before use in case of 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
Additional Listing Data#
Finished product Yes
Brand name base Bacitracin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN 500 [USP'U]/g
Harmonized Identifiers# Field, Values table Field Values Unii 58H6RWO52I Rxcui 1648110
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0713-0280-31 Bacitracin 28.4 g in 1 TUBE OINTMENT 28.4 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Bacitracin ACTIVE INGREDIENT 58H6RWO52I BACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC] 2 Bacitracin ACTIVE MOIETY 58H6RWO52I BACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC] 2 Light Mineral Oil INACTIVE INGREDIENT N6K5787QVP BACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC] 2 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U BACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC] 2 Bacitracin ACTIVE INGREDIENT 58H6RWO52I BACITRACIN (BACITRACIN) OINTMENT [G&W LABORATORIES, INC.] 1 Bacitracin ACTIVE MOIETY 58H6RWO52I BACITRACIN (BACITRACIN) OINTMENT [G&W LABORATORIES, INC.] 1 Light Mineral Oil INACTIVE INGREDIENT N6K5787QVP BACITRACIN (BACITRACIN) OINTMENT [G&W LABORATORIES, INC.] 1 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U BACITRACIN (BACITRACIN) OINTMENT [G&W LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0280 BACITRACIN OINTMENT [COSETTE PHARMACEUTICALS, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20231221_630e0841-baf2-e9fa-b309-ad1a5f95da3b.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 0713-0280-31 00713028031 28.4 g in 1 TUBE (0713-0280-31) 28.4 g 1995-01-10 0000-00-00 No No Current