FDA.reportPublic FDA data

Bacitracin Zinc

Product NDC
52000-059
11-digit product format
520000059
Labeler code
52000
Product ID
52000-059_f1fda823-b34b-4749-b179-6b8f81e91a2c
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52000-059IInactivated by FDA2026-10-28
excluded packagepackage52000-05952000-059-01IInactivated by FDA2026-10-28

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52000-059-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52000-059-01f5e01cc5f278…a2eaf40c39c3…

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
Bacitracin Zinc
Listing expiration
2027-12-31

Active Ingredients#

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

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 6 of 21 · 420 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Caring Mills Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEVeridian Healthcarefbd11419-4513-10d7-e053-6394a90ac82b2025-12-27WarningsExact identifier
application number: M004
Caring Mill Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVeridian Healthcare8cd0cd64-fe62-4225-8986-5e8641dd6df22025-12-22WarningsExact identifier
application number: M004
PS-2261 Triple Antibiotic, 0.5gPS-2261 TRIPLE ANTIBIOTIC, 0.5GProStat First Aid LLC0072f8de-fc06-d529-e063-6294a90a08db2025-12-15WarningsExact identifier
application number: M004
PS - 2895 Triple Antibiotic , 0.5gPS - 2895 TRIPLE ANTIBIOTIC , 0.5GProstat First Aid LLC0050de33-914b-f76d-e063-6394a90a7fab2025-12-15WarningsExact identifier
application number: M004
Triple AntibioticTRIPLE ANTIBIOTICProStat First Aidf76d7d18-0fa1-d943-e053-6294a90ac20a2025-12-15WarningsExact identifier
application number: M004
Triple AntibioticTRIPLE ANTIBIOTICFront Line Safety0f509f96-a083-37d1-e063-6394a90a622c2025-12-15WarningsExact identifier
application number: M004
ElixirTripleGuard Triple AntibioticBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN BELIXIR HEALTHCARE USA, LLC.43edfb80-4d50-9362-e063-6394a90a21992025-12-13WarningsExact identifier
application number: M004
El Valle Decolorized IodineALCOHOLPharmadel LLCfd7a227b-536c-b3f7-e053-6394a90a41582025-12-04WarningsExact identifier
application number: M004
Vitastem First Aid AntibioticTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC3970ac49-ab0f-4492-ba61-95a12faed5002025-12-02WarningsExact identifier
application number: M004
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
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

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 startMarketing endSampleExclude flagStatus
52000-059-01520000059011 TUBE in 1 CARTON (52000-059-01) > 14 g in 1 TUBE1 tube2020-12-090000-00-00NoNoCurrent
52000-059-03520000059031 TUBE in 1 CARTON (52000-059-03) / 14 g in 1 TUBE1 tube2020-12-09NoNoCurrent