FDA.reportPublic FDA data

Bacitracin

Product NDC
50090-0815
11-digit product format
500900815
Labeler code
50090
Product ID
50090-0815_ded7927b-d0a3-42eb-8f36-afea1eec6b0f
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-06-20
Substance
BACITRACIN
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN500 [USP'U]/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
00747e3a-389c-46bc-b6b9-9b3d1d98dbcfAvailable 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
50090-0815-02023-02-06C16284748780-1f386c649-b05a-0266-e053-dadaa90a7c1aBacitracin Drug Facts
50090-0815-02023-01-30C16284748780-1f386c649-b05a-0266-e053-dadaa90a7c1aBacitracin Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0815-0Bacitracin1 in 1 CARTONOINTMENT120
50090-0815-0Bacitracin14 g in 1 TUBEOINTMENT1420

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0815-0GM - Gram50090-081589c6137b-4142-4a00-b8be-ace6a31d9bc112018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0815BACITRACIN OINTMENT [A-S MEDICATION SOLUTIONS]20Current NDC, Legacy NDC, 2 package rows20241107_00747e3a-389c-46bc-b6b9-9b3d1d98dbcf.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 1 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATENuCare Pharmaceutical, Inc.5b14499e-e45c-7c05-e063-6294a90a1cc22026-09-09WarningsExact identifier
application number: M004
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0df2da-1688-c477-e053-2995a90a74a22026-09-07WarningsExact identifier
application number: M004
American Safety and First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Inceb0d108f-42bf-3364-e053-2a95a90a45422026-09-07WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4d0a4-b90c-99b0-e053-2995a90ab4232026-09-04WarningsExact identifier
application number: M004
Lil Drug Store Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INCe6e5263b-328f-4775-9fac-34302f050ce02026-09-04WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e42c5c-e080-4efb-e053-2a95a90af52e2026-09-04WarningsExact identifier
application number: M004
MEDI-FIRSTBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEOrazen Incf4e4854a-ee01-df72-e053-2995a90aa8ea2026-09-04WarningsExact identifier
application number: M004
Circle K Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEORAZEN INC84c3f7e4-b28b-40bb-8d9d-7c8d679e3a3a2026-09-04WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyb982091a-5aa0-4bbc-bb1d-08016f6d0a702026-09-03WarningsExact identifier
application number: M004
SurviveX Triple AntibioticTRIPLE ANTIBIOTICNantong Health & Beyond Hygienic Products Inc.5a7cb52d-a60c-b947-e063-6394a90afb0d2026-09-02WarningsExact identifier
application number: M004
triple antibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BWalgreen Company4f3cfe39-2df8-48b4-954d-5997217c92ba2026-08-31WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINCNINGBO TIANBO FIRST AID PRODUCT CO., LTD.217aa2b8-94f5-468a-99b4-52824a77b5732026-08-28WarningsExact identifier
application number: M004
OP Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEYiwu Ori-Power Medtech Co., Ltd.03f3cce9-7e9f-90a6-e063-6294a90a660b2026-08-28WarningsExact identifier
application number: M004
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA Inc.5dc007a2-61fa-4115-a82c-1aa489a6bd392026-08-27WarningsExact identifier
application number: M004
InstantFoam Complete PUREALCOHOLSC Johnson Professional USA Inc.398ca23c-7202-4670-be14-9829675f71742026-08-27WarningsExact identifier
application number: M004
Be Smart Get Prepared Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATETotal Resources International, Inc57ed1a03-7e1b-4eb4-8001-dfd118805edc2026-08-24WarningsExact identifier
application number: M004
ClaravieBACITRACIN ZINCGentell LLC59c5a363-6d79-d07e-e063-6294a90a87532026-08-24WarningsExact identifier
application number: M004
ClaravieBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN BGentell LLC597cb2f0-ff05-a1ab-e063-6294a90acda92026-08-20WarningsExact identifier
application number: M004
Medpride First AidBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATEShield Line LLC5ba3e703-7873-4724-a0bf-bb22d8a257482026-08-18WarningsExact identifier
application number: M004
Medpride First AidBACITRACIN ZINCShield Line LLCe6a6fb0f-5ab7-4647-84a0-7b9948eed3032026-08-18WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN00747e3a-389c-46bc-b6b9-9b3d1d98dbcf20
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD00747e3a-389c-46bc-b6b9-9b3d1d98dbcf20
1648110bacitracin 500 UNT per GM Topical OintmentSY00747e3a-389c-46bc-b6b9-9b3d1d98dbcf20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0815-0500900815001 TUBE in 1 CARTON (50090-0815-0) / 14 g in 1 TUBE1 tube2014-11-280000-00-00NoNoCurrent