FDA.reportPublic FDA data

MediChoice Bacitracin

Product NDC
39892-0810
11-digit product format
398920810
Labeler code
39892
Product ID
39892-0810_40b3f918-d4a6-96e3-e063-6294a90aa273
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
O&M HALYARD, INC.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-26
Substance
BACITRACIN
Active strength
500 [iU]/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 packagepackage39892-081039892-0810-3DDiscontinued by firm2026-10-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
MediChoice Bacitracin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN500 [iU]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
58H6RWO52IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1648110Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
78079b94-c6fc-4529-aaad-8186924ecba5Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39892-0810-1MediChoice Bacitracin144 in 1 BOXOINTMENT1449
39892-0810-1MediChoice Bacitracin0.9 g in 1 PACKETOINTMENT0.99
39892-0810-3MediChoice Bacitracin28.35 g in 1 TUBEOINTMENT28.359
39892-0810-3MediChoice Bacitracin1 in 1 CARTONOINTMENT19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39892-0810MEDICHOICE BACITRACIN (BACITRACIN) OINTMENT [OWENS & MINOR, INC]8Current NDC, Legacy NDC, 4 package rows20231210_78079b94-c6fc-4529-aaad-8186924ecba5.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 14 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Antibiotic plus Burn ReliefBACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCITrifecta Pharmaceuticals USA LLC048871e2-c917-292d-e063-6394a90af1302024-12-18WarningsExact identifier
application number: M004
TheraCare Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEVeridian Healthcare0c3fc798-9a97-5316-e063-6394a90a68302024-12-18WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCRugby Laboratoriesac3c9897-c812-1360-e053-2a95a90ad5912024-12-17WarningsExact identifier
application number: M004
Major BacitracinBACITRACIN ZINCMajor Pharmaceuticalsa23ce772-7078-0a4b-e053-2995a90aff0d2024-12-17WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLCeea0d90c-914b-2624-e053-2a95a90a34c92024-12-13WarningsExact identifier
application number: M004
OP First Aid Series TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.cadebf07-dd48-4855-8296-7a91e28d71232024-12-05WarningsExact identifier
application number: M004
triple antibiotic and pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDECVS Pharmacyf0864d78-23e6-4e6c-bc67-7ba3e6dd862c2024-12-03WarningsExact identifier
application number: M004
triple antibioticBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEPublix Super Markets Inc330c7b7a-d0d1-42dc-b8f7-9c96aeaf69f92024-11-25WarningsExact identifier
application number: M004
WinCo Maximum Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDEWinCo Foods, LLC01b03c7e-6c4e-43aa-8480-aff1c2688f7f2024-11-21WarningsExact identifier
application number: M004
WinCo Original Strength Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEWinCo Foods, LLCe364b623-6e20-4894-8d4c-5c739be78f862024-11-21WarningsExact identifier
application number: M004
Winco Bacitracin ZincBACITRACIN ZINCWinCo Foods, LLCdcdf647f-fa32-4b72-b714-a77e8e3323582024-11-21WarningsExact identifier
application number: M004
Walgreens Multi-Antibiotic with Pain Relief CreamPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDEWalgreens Companyf4feccc3-ac25-4d8a-9b68-9a24f755524a2024-11-20WarningsExact identifier
application number: M004
Walgreens Kids Multi-Antibiotic with Pain Relief CreamPOLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDEWalgreens Companyfbc364d7-d8b8-43f5-99cc-290438f3982b2024-11-20WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAcme United Corporationf9a48f73-aa12-cf68-e053-6294a90a8e532024-11-19WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEAcme United Corporatione55cbf7e-c955-7f1a-e053-2a95a90a3f282024-11-19WarningsExact identifier
application number: M004
First Aid Only Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEAcme United Corporationf4eba34c-ce31-3004-e053-2995a90a245b2024-11-19WarningsExact identifier
application number: M004
First Aid Only Neomycin AntibioticNEOMYCIN SULFATEAcme United Corporationc651e98e-aabe-de46-e053-2a95a90a63072024-11-19WarningsExact identifier
application number: M004
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLCf07d3bca-4312-46ed-b0c4-f886c01bd0952024-11-14WarningsExact identifier
application number: M004
Polysporin First Aid AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEKenvue Brands LLCe0fcf83e-a374-4fc0-a629-8730330543922024-11-14WarningsExact identifier
application number: M004
Neosporin Pain Itch ScarBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC55392c48-b5d8-44cd-8c10-6d86683498482024-11-13WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN78079b94-c6fc-4529-aaad-8186924ecba59
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD78079b94-c6fc-4529-aaad-8186924ecba59
1648110bacitracin 500 UNT per GM Topical OintmentSY78079b94-c6fc-4529-aaad-8186924ecba59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39892-0810-139892081001144 PACKET in 1 BOX (39892-0810-1) / .9 g in 1 PACKET144 packet2015-03-260000-00-00NoNoCurrent
39892-0810-33989208100328.35 g in 1 TUBE28.35 gHistorical