Home NDC 0404-0170 Bacitracin Zinc
Product NDC 0404-0170
11-digit product format 004040170
Labeler code 0404
Product ID 0404-0170_446e5a97-d7cc-b090-e063-6294a90aa7c3
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin Zinc
Dosage form OINTMENT
Route TOPICAL
Labeler Henry Schein
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-07
Substance BACITRACIN ZINC
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 over large areas of the body • If you are allergic to any of the ingredients • Longer than 1 week unless directed by a doctor When using this product there are no side effects. Ask a doctor or pharmacist before use if you have deep or punction 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 Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Additional Listing Data#
Finished product Yes
Brand name base Bacitracin Zinc
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 500 [iU]/g
Harmonized Identifiers# Field, Values table Field Values Unii 89Y4M234ES Rxcui 1366116
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0404-0170-50 Bacitracin Zinc 1 in 1 BOX OINTMENT 1 4 0404-0170-50 Bacitracin Zinc 72 in 1 CASE OINTMENT 72 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-0170 BACITRACIN ZINC OINTMENT [HENRY SCHEIN] 3 Current NDC, Legacy NDC, 2 package rows 20241129_eaf1555d-7a3d-7ccb-e053-2995a90af62e.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 0404-0170-50 00404017050 72 BOX in 1 CASE (0404-0170-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE 72 box 2022-11-07 0000-00-00 No No Current