FDA.reportPublic FDA data

Bacitracin

Product NDC
0363-0075
11-digit product format
003630075
Labeler code
0363
Product ID
0363-0075_5fe2079a-2e5d-4a55-8f26-3e94a3b32f88
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Walgreen Company
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-10-24
Marketing end
0000-00-00
Substance
BACITRACIN
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct0363-0075IInactivated by FDA2026-07-31
excluded packagepackage0363-00750363-0075-64IInactivated 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
0363-0075-642025-01-30C16284748780-12cef2736-7c98-d83d-e063-dadaa90ab31fWalgreen Co. Bacitracin Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0075-64Bacitracin1 in 1 CARTONOINTMENT14
0363-0075-64Bacitracin28 g in 1 TUBEOINTMENT284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0075-64GM - Gram0363-0075c0663ed4-dcbb-45b8-9040-759cd2b84b9912024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0075BACITRACIN OINTMENT [WALGREEN COMPANY]4Legacy NDC, 2 package rows20220121_4bf2dbef-67e8-4e99-be31-f9b838cd06b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN4bf2dbef-67e8-4e99-be31-f9b838cd06b94
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD4bf2dbef-67e8-4e99-be31-f9b838cd06b94
1648110bacitracin 500 UNT per GM Topical OintmentSY4bf2dbef-67e8-4e99-be31-f9b838cd06b94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0075-64003630075641 TUBE in 1 CARTON (0363-0075-64) > 28 g in 1 TUBE1 tube2016-10-240000-00-00NoNoCurrent