FDA.reportPublic FDA data

Bacitracin

Product NDC
68788-9794
11-digit product format
687889794
Labeler code
68788
Product ID
68788-9794_4ff36624-bdb7-4bb1-8cef-c976cd3d4d5d
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Preferred Pharmaceuticals, Inc
Application
333B
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-04-30
Substance
BACITRACIN
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-979468788-9794-1DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
Bacitracin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
58H6RWO52IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1648110Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9794-1Bacitracin14 g in 1 TUBEOINTMENT1412
68788-9794-2Bacitracin28 g in 1 TUBEOINTMENT2812

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BacitracinACTIVE INGREDIENT58H6RWO52IBACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC]2
BacitracinACTIVE MOIETY58H6RWO52IBACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC]2
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPBACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9UBACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9794BACITRACIN OINTMENT [PREFERRED PHARMACEUTICALS, INC]11Current NDC, Legacy NDC, 2 package rows20250207_5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BacitracinBACITRACINPreferred Pharmaceuticals, Inc5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd92026-03-16WarningsExact identifier
ndc (product): 68788-9794

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1648110bacitracin 500 UNT in GM Topical OintmentPSN5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd912
1648110bacitracin 0.5 UNT/MG Topical OintmentSCD5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd912
1648110bacitracin 500 UNT per GM Topical OintmentSY5b75944b-f0cb-4ba6-b1b2-bb8dd0114cd912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9794-16878897940114 g in 1 TUBE14 gHistorical
68788-9794-26878897940228 g in 1 TUBE (68788-9794-2) 28 g2012-04-300000-00-00NoNoCurrent