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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N000004-004PAREDRINEHYDROXYAMPHETAMINE HYDROBROMIDE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982

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
BacitracinBACITRACINA-S Medication Solutions00747e3a-389c-46bc-b6b9-9b3d1d98dbcf2024-11-06WarningsExact 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 • over large areas of the body • if you are allergic to any of the ingredients Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns Stop use and ask a doctor if • you need to use longer than 1 week • condition persists or gets worse • rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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
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

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