FDA.reportPublic FDA data

Bacitracin

Product NDC
68071-5253
11-digit product format
680715253
Labeler code
68071
Product ID
68071-5253_1d78bc6e-79b8-c6be-e063-6394a90a18f8
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-01-10
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

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
BacitracinBACITRACINNuCare Pharmaceuticals,Inc.a526ae4b-baae-5d50-e053-2a95a90ae2932024-07-17WarningsExact 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 • if you are allergic to any of the ingredients • in the eyes • over large areas of the body • longer than 1 week unless directed by a doctor Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if • the condition persists or gets worse • a rash or other allergic reaction develops

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 Identifiers#

Field, Values table
FieldValues
Unii58H6RWO52I
Rxcui1648110

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
68071-5253-32022-02-07C16284748780-1d6a99b39-a5ab-a426-e053-dadaa90af4c2Bacitracin Ointment
68071-5253-32022-01-28C16284748780-1d6a99b39-a5ab-a426-e053-dadaa90af4c2Bacitracin Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5253-3Bacitracin28.4 g in 1 BOXOINTMENT28.44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5253BACITRACIN OINTMENT [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240727_a526ae4b-baae-5d50-e053-2a95a90ae293.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSNa526ae4b-baae-5d50-e053-2a95a90ae2934
1648110bacitracin 0.5 UNT/MG Topical OintmentSCDa526ae4b-baae-5d50-e053-2a95a90ae2934
1648110bacitracin 500 UNT per GM Topical OintmentSYa526ae4b-baae-5d50-e053-2a95a90ae2934

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5253-36807152530328.4 g in 1 BOX (68071-5253-3) 28.4 g2020-05-080000-00-00NoNoCurrent