FDA.reportPublic FDA data

Bacitracin Zinc

Product NDC
52000-059
Requested package NDC
52000-059-03
11-digit product format
520000059
Labeler code
52000
Product ID
52000-059_4ed8ba41-9e6d-4155-92cf-9bf44a70a169
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-09
Substance
BACITRACIN ZINC
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bacitracin Zinc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1366116Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
186b2750-5bf6-1702-e063-6294a90a62b3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-059-012025-07-29C16284748780-13b156c62-2ace-fb37-e063-e6dba90a4e07Bacitracin Zinc Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-059-01Bacitracin Zinc1 in 1 CARTONOINTMENT14
52000-059-01Bacitracin Zinc14 g in 1 TUBEOINTMENT144
52000-059-03Bacitracin Zinc1 in 1 CARTONOINTMENT13
52000-059-03Bacitracin Zinc14 g in 1 TUBEOINTMENT143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-059BACITRACIN ZINC OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]4Current NDC, Legacy NDC, 2 package rows20241212_39ec0cee-7d19-464d-9ac8-ba2d736bd186.zip
52000-059BACITRACIN ZINC OINTMENT [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 2 package rows20241218_186b2750-5bf6-1702-e063-6294a90a62b3.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 5 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thera Plus Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEFourstar Group USA, Inc2f916502-4daf-4cb9-a638-f37bb96c80772025-12-02WarningsExact identifier
application number: M004
CAREALL BacitracinBACITRACIN ZINCNew World Imports, Incea16e1de-0100-456b-abe6-d33de78221da2025-12-02WarningsExact identifier
application number: M004
Triple Antibiotic Ointment, Circle KTRIPLE ANTIBIOTIC OINTMENTLil' Drug Store Products, Inc.44e5107e-832a-2ce6-e063-6294a90a711d2025-12-01WarningsExact identifier
application number: M004
Viaderma Care First Aid AntibioticBACITRACIN ZINCVIADERMA DISTRIBUTION INC0f36f396-e479-486c-b047-2760477609e22025-12-01WarningsExact identifier
application number: M004
CareALL Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLNew World Imports, Inc1982b664-e8fd-4030-aa89-f7543e1b487b2025-12-01WarningsExact identifier
application number: M004
CareALL Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENew World Imports, Inc9c2d417e-6fec-42f4-9f0c-2ec79de9342d2025-12-01WarningsExact identifier
application number: M004
BacitracinBACITRACINBryant Ranch Prepack5b0249c0-c196-4d3c-973f-49bd2d3d4a752025-12-01WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCHenry Scheineaf03943-c7a5-724e-e053-2995a90a3e6c2025-11-25WarningsExact identifier
application number: M004
Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B SulfateBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEHenry Scheinead9496b-112e-59e6-e053-2995a90a768c2025-11-25WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCHenry Scheineaf1555d-7a3d-7ccb-e053-2995a90af62e2025-11-25WarningsExact identifier
application number: M004
Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin SulfateBACITRACIN ZINC, POLYMYXIN B SULFATE, AND NEOMYCIN SULFATEHenry Scheineadb847e-aefe-41cf-e053-2995a90af2cd2025-11-25WarningsExact identifier
application number: M004
Neosporin Plus LidocaineBACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINEKenvue Brands LLCe450b6a1-a8da-e5db-e053-2995a90a0ef02025-11-24WarningsExact identifier
application number: M004
ElixirZincoCareZINC OXIDE 20%ELIXIR HEALTHCARE USA, LLC.bac18496-3b76-4faf-abde-968d79b718d82025-11-22WarningsExact identifier
application number: M004
Hand-AidALCOHOLABC Compounding Co., Inc.788d7584-bc33-49e8-90fd-767045ea29142025-11-19WarningsExact identifier
application number: M004
VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTICNEOMYCIN SULFATECompania Internacional de Comercio, S.A.P.I de C.V.ba7a3331-466e-496f-bebd-9ee7067bcdb22025-11-19WarningsExact identifier
application number: M004
dabur First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEDabur India Limited229170a3-ef9e-597d-e063-6394a90acf8b2025-11-18WarningsExact identifier
application number: M004
QS Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDERomaine Companies5e16f52d-3bf3-4897-bd3a-cf4e117583c92025-11-18WarningsExact identifier
application number: M004
Hand Guard Foaming Instant Hand SanitizerALCOHOLWechem, Inc.d9b89f90-aece-48a2-862a-c524d3c908412025-11-18WarningsExact identifier
application number: M004
Puri-San Plus Instant Hand SanitizerBENZEALKONIUM CHLORIDEPeople's Janitorial Supplyf0726bdd-9d2b-4383-af10-e2e0c5460e1e2025-11-18WarningsExact identifier
application number: M004
Lynx san a foamALCOHOLABC Compounding Co., Inc.2b987ebc-c73b-edbd-e063-6394a90a1d2d2025-11-18WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN39ec0cee-7d19-464d-9ac8-ba2d736bd1864
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD39ec0cee-7d19-464d-9ac8-ba2d736bd1864
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY39ec0cee-7d19-464d-9ac8-ba2d736bd1864
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN186b2750-5bf6-1702-e063-6294a90a62b33
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD186b2750-5bf6-1702-e063-6294a90a62b33
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY186b2750-5bf6-1702-e063-6294a90a62b33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52000-059-03520000059031 TUBE in 1 CARTON (52000-059-03) / 14 g in 1 TUBE1 tube2020-12-09NoNoCurrent