FDA.reportPublic FDA data

Bacitracin Zinc

Product NDC
52000-059
Requested package NDC
52000-059-01
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52000-05952000-059-01IInactivated by FDA2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52000-05952000-059-01IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52000-05952000-059-01IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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 17 of 22 · 430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
careone triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEAmerican Sales Company9df0c4c2-f045-4f25-878e-4d55a99b8df42024-10-06WarningsExact identifier
application number: M004
DG Health AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLDolgencorp, LLC0a04da51-d169-4eff-b70c-352913ce39662024-10-06WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLSafeway8d5bac6b-98b6-4fc4-983a-ca5292b4c3612024-10-06WarningsExact identifier
application number: M004
antibiotic plus pain reliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEKroger Company91828614-d0d1-472f-802f-43f4738601252024-09-26WarningsExact identifier
application number: M004
DG Health AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLDolgencorp Incefaf3ea5-0a2f-414f-96eb-7e8cfba9e9012024-09-26WarningsExact identifier
application number: M004
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BA-S Medication Solutions29c223ff-3cb7-4578-a326-08516e89cd472024-09-26WarningsExact identifier
application number: M004
Signature Care First Aid AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLSafeway78ecfb28-f4c4-4f70-90c9-d6d7bf920fb52024-09-26WarningsExact identifier
application number: M004
Good Neighbor Pharmacy Antibiotic and Pain ReliefNEOMYCIN, POLYMYXIN B, PRAMOXINE HCLAmerisource Bergen3d1694ea-3f3e-45d5-8edf-8b31ac7d3a402024-09-26WarningsExact identifier
application number: M004
Rexall AntibioticBACITRACINDolgencorp, LLC7ad42602-6e42-47c8-91a8-e4785fa8d24b2024-09-23WarningsExact identifier
application number: M004
bacitracinBACITRACINH E B0a5eeef0-309b-4edd-a664-3d9c1c74a6e92024-09-23WarningsExact identifier
application number: M004
signature care first aid antibioticBACITRACINSafeway38fc0c5c-e0bc-44d2-acbd-d4d329fef1e12024-09-23WarningsExact identifier
application number: M004
AntibioticBACITRACINTopco Associates LLC3267a695-9e53-42f2-b30a-022653a0b8bb2024-09-23WarningsExact identifier
application number: M004
BacitracinBACITRACINKroger Company4490cece-0635-4ea7-91ab-324a971fef632024-09-23WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BPadagis Israel Pharmaceuticals Ltd28fff253-ddd4-4669-aa90-b4caf48c905f2024-09-22WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BSafeway044aff98-f398-40f5-8c18-2751b4ab43842024-09-18WarningsExact identifier
application number: M004
careone triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAmerican Sales Company09a0b0b9-1806-4ff9-80fa-448dabbf2cc72024-09-18WarningsExact identifier
application number: M004
equaline first aid antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BUnited Natural Foods, Inc. dba UNFI022e009e-0192-4089-86f3-4d63448e0f882024-09-18WarningsExact identifier
application number: M004
DG Health Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BDolgencorp, LLC1694f4ee-1065-4b13-b642-b8437f4735412024-09-18WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BKroger Companyc531bac4-ab15-4fde-99a7-19e20ce103872024-09-17WarningsExact identifier
application number: M004
EQUATE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWal-Mart Stores Incfa35f446-6a58-4d8c-859e-89cd631a9e8f2024-09-17WarningsExact 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