Home NDC 70000-0093 Leader Poly Bacitracin
Product NDC 70000-0093
11-digit product format 700000093
Labeler code 70000
Product ID 70000-0093_b1969426-55b8-4cae-9bb7-f641c971667e
Type HUMAN OTC DRUG
Nonproprietary name FIRST AID ANTIBIOTIC
Dosage form OINTMENT
Route TOPICAL
Labeler Cardinal Health 110, Inc.
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-06-01
Substance BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength 500; 10000 [USP'U]/g; [USP'U]/g
Pharmacologic classes Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
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 Allergy alert: do not use if you are allergic to any of the ingredients Do not use in or near the eyes on large areas of the body Consult a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not use longer than 1 week Stop use and consult a doctor if condition persists or gets worse symptoms last for more than 7 days or clear up and come back within a few days a rash or other allergic reaction develops Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.
Additional Listing Data#
Finished product Yes
Brand name base Leader Poly Bacitracin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BACITRACIN ZINC 500 [USP'U]/g POLYMYXIN B SULFATE 10000 [USP'U]/g
Harmonized Identifiers# Field, Values table Field Values Unii 89Y4M234ES, 19371312D4 Rxcui 308512
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0093-1 Leader Poly Bacitracin 14 g in 1 TUBE OINTMENT 14 2 70000-0093-1 Leader Poly Bacitracin 1 in 1 CARTON OINTMENT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0093 LEADER POLY BACITRACIN (FIRST AID ANTIBIOTIC) OINTMENT [CARDINAL HEALTH 110, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240119_442e11aa-7d14-44f9-bf14-446018f1de0d.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 70000-0093-1 70000009301 1 TUBE in 1 CARTON (70000-0093-1) / 14 g in 1 TUBE 1 tube 2021-06-01 0000-00-00 No No Current