FDA.reportPublic FDA data

Bacitracin

Product NDC
50090-0846
11-digit product format
500900846
Labeler code
50090
Product ID
50090-0846_e23d20e0-1036-4579-9dfe-17901040bf86
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1995-01-10
Marketing end
0000-00-00
Substance
BACITRACIN
Active strength
500 [USP'U]/g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0846IInactivated by FDA2026-07-31
excluded packagepackage50090-084650090-0846-0IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Water-Jel 3-in-1 AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATEWater-Jel Technologiesd5fcaffd-af38-4285-a79c-6df7424c76fa2017-11-16WarningsExact identifier
CVS Triple AntibioticBACITRACIN, NEOMYCIN, POLYMYXIN BCVS Pharmacy454bfeed-f58f-003a-e054-00144ff8d46c2017-01-04WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Do not use in the eyes or over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor Ask a doctor before use if you have a deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.

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
50090-0846-02023-01-30C16284748780-1f386c64a-3f46-0266-e053-dadaa90a7c1aBacitracin Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0846-0Bacitracin28.4 g in 1 TUBEOINTMENT28.47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0846-0GM - Gram50090-08465b6122be-98a2-4aae-bbd9-65015c29556012018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0846BACITRACIN (BACITRACIN) OINTMENT [A-S MEDICATION SOLUTIONS]7Legacy NDC, 1 package rows20210211_19007db7-fc17-4e31-9ce9-c9e7d3584961.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN19007db7-fc17-4e31-9ce9-c9e7d35849617
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD19007db7-fc17-4e31-9ce9-c9e7d35849617
1648110bacitracin 500 UNT per GM Topical OintmentSY19007db7-fc17-4e31-9ce9-c9e7d35849617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0846-05009008460028.4 g in 1 TUBE (50090-0846-0) 28.4 g2014-11-280000-00-00NoNoCurrent