FDA.reportPublic FDA data

Bacitracin

Product NDC
42254-031
11-digit product format
422540031
Labeler code
42254
Product ID
42254-031_fea57e0a-c472-4c83-9afd-6765a16600b9
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-06-20
Marketing end
0000-00-00
Substance
BACITRACIN
Active strength
500 [USP'U]/g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct42254-031IInactivated by FDA2026-07-31
excluded packagepackage42254-03142254-031-15IInactivated 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
42254-031-152019-09-24C16284748780-19350213a-3bff-c013-e053-90daa90a1393Bacitracin Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-031-15Bacitracin0.9 g in 1 PACKETOINTMENT0.91
42254-031-15Bacitracin144 in 1 CARTONOINTMENT1441

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-031-15GM - Gram42254-0313f9d93a5-b7fe-4e83-812f-1380eaec8b0712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IBACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1
BACITRACINACTIVE MOIETY58H6RWO52IBACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPBACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UBACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-031BACITRACIN OINTMENT [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120316_fea57e0a-c472-4c83-9afd-6765a16600b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSNfea57e0a-c472-4c83-9afd-6765a16600b91
1648110bacitracin 0.5 UNT/MG Topical OintmentSCDfea57e0a-c472-4c83-9afd-6765a16600b91
1648110bacitracin 500 UNT per GM Topical OintmentSYfea57e0a-c472-4c83-9afd-6765a16600b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
42254-031-15422540031150.9 g in 1 PACKET0.9 gHistorical