Home NDC 68001-477 Bacitracin
Product NDC 68001-477
11-digit product format 680010477
Labeler code 68001
Product ID 68001-477_097d4e93-7f8a-53f8-e063-6294a90a4e40
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin
Dosage form OINTMENT
Route TOPICAL
Labeler BluePoint Laboratories
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-11-24
Substance BACITRACIN
Active strength 500 [iU]/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 in the eyes or apply over large areas of body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor
Additional Listing Data#
Finished product Yes
Brand name base Bacitracin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN 500 [iU]/g
Harmonized Identifiers# Field, Values table Field Values Unii 58H6RWO52I Rxcui 1648110
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-477 BACITRACIN OINTMENT [BLUEPOINT LABORATORIES] 5 Current NDC, Legacy NDC, 6 package rows 20231118_b4d8ef06-6269-68f7-e053-2995a90ac8ea.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 68001-477-45 68001047745 0.9 g in 1 PACKET 0.9 g Historical 68001-477-46 68001047746 1 TUBE in 1 CARTON (68001-477-46) / 14.2 g in 1 TUBE 1 tube 2020-11-24 0000-00-00 No No Current 68001-477-47 68001047747 1 TUBE in 1 CARTON (68001-477-47) / 28.4 g in 1 TUBE 1 tube 2020-11-24 0000-00-00 No No Current 68001-477-48 68001047748 1 PACKET in 1 CARTON (68001-477-48) / .9 g in 1 PACKET (68001-477-45) 1 packet 2020-11-24 0000-00-00 No No Current