Home NDC 67777-116 Bacitracin
Product NDC 67777-116
11-digit product format 677770116
Labeler code 67777
Product ID 67777-116_275e9fdf-28d0-498a-e063-6294a90a7eea
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin
Dosage form OINTMENT
Route TOPICAL
Labeler Dynarex Corporation
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-09-12
Substance BACITRACIN
Active strength 500 [USP'U]/1000mg
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 the body If you are allergic to any of the ingredients Longer than 1 week unless directed by a doctor Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns If swallowed, get medical help or contact a Poison Control Center right away.
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]/1000mg
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 67777-116 BACITRACIN OINTMENT [DYNAREX CORPORATION] 10 Current NDC, Legacy NDC, 8 package rows 20241122_7f8752c7-6839-261d-e053-2991aa0a0c30.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 67777-116-10 67777011610 1728 BOX in 1 CASE (67777-116-10) / 144 PACKET in 1 BOX (67777-116-11) / 900 mg in 1 PACKET 1728 box 2016-09-12 0000-00-00 No No Current 67777-116-11 67777011611 144 in 1 BOX Historical 67777-116-20 67777011620 72 TUBE in 1 CASE (67777-116-20) / 14000 mg in 1 TUBE (67777-116-21) 72 tube 2016-09-12 0000-00-00 No No Current 67777-116-21 67777011621 14000 mg in 1 TUBE 14000 mg Historical 67777-116-30 67777011630 72 BOX in 1 CASE (67777-116-30) / 1 TUBE in 1 BOX (67777-116-31) / 28400 mg in 1 TUBE 72 box 2016-09-12 0000-00-00 No No Current 67777-116-31 67777011631 28400 mg in 1 TUBE 28400 mg Historical