Home NDC 70000-0694 Leader Poly Bacitracin
Product NDC 70000-0694
11-digit product format 700000694
Labeler code 70000
Product ID 70000-0694_20d75f8e-2a81-2653-e063-6394a90a88a4
Type HUMAN OTC DRUG
Nonproprietary name Bacitracin Zinc Polymixin B Sulfate
Dosage form OINTMENT
Route TOPICAL
Labeler Cardinal Health 110 dba LEADER
Application M004
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-15
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 89Y4M234ES Internal UNII lookup 19371312D4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308512 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0694-1 Leader Poly Bacitracin 1 in 1 BOX OINTMENT 1 1 70000-0694-1 Leader Poly Bacitracin 28 g in 1 TUBE OINTMENT 28 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0694 LEADER POLY BACITRACIN (BACITRACIN ZINC POLYMIXIN B SULFATE) OINTMENT [CARDINAL HEALTH 110 DBA LEADER] 1 Current NDC, 2 package rows 20240901_20d7624f-cafa-25e1-e063-6394a90a4439.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 22 of 22 · 424 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Family Wellness Antiseptic and Pain Relief BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE FRONT PHARMACEUTICAL PLC cb7fdcde-2bd8-4834-ba4e-4d6fd1512599 2023-10-26 Warnings Exact identifier application number: M004 GENUINE FIRST AID Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Nantong Health & Beyond Hygienic Products Inc. 23abfe12-5b50-4b49-878e-4fcdb6c341fd 2023-10-19 Warnings Exact identifier application number: M004 EVERLIT CARE Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Nantong Health & Beyond Hygienic Products Inc. f4921508-c32f-426f-a2f0-16c3acbd4713 2023-10-14 Warnings Exact identifier application number: M004 Cuadriderma BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE ProMex LLC 4fa99b96-ab4b-4523-82bc-343dbaf39fb6 2022-01-25 Warnings Exact identifier application number: M004
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70000-0694-1 70000069401 1 TUBE in 1 BOX (70000-0694-1) / 28 g in 1 TUBE 1 tube 2024-08-15 No No Current