FDA.reportPublic FDA data

Premier Value

Product NDC
68016-075
11-digit product format
680160075
Labeler code
68016
Product ID
68016-075_e668129e-d90d-472d-86de-862522ed971a
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Pharmacy Value Alliance LLC
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2006-05-11
Marketing end
0000-00-00
Substance
BACITRACIN ZINC
Active strength
500 [iU]/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-075IInactivated by FDA2026-09-14
excluded packagepackage68016-07568016-075-02IInactivated by FDA2026-09-14

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68016-075-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-075-02f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
68016-075-022025-07-29C16284748780-13b156c62-2b34-fb37-e063-e6dba90a4e07Premier Value ® Bacitracin Zinc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-075-02Premier Value Bacitracin Zinc28.4 g in 1 TUBEOINTMENT28.42
68016-075-02Premier Value Bacitracin Zinc1 in 1 CARTONOINTMENT12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESPREMIER VALUE BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [CHAIN DRUG CONSORTIUM]1
BacitracinACTIVE MOIETY58H6RWO52IPREMIER VALUE BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [CHAIN DRUG CONSORTIUM]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPPREMIER VALUE BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [CHAIN DRUG CONSORTIUM]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UPREMIER VALUE BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-075PREMIER VALUE BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [PHARMACY VALUE ALLIANCE LLC]2Legacy NDC, 2 package rows20170711_2ae07bb1-4383-4eec-89c2-820b099e905a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN2ae07bb1-4383-4eec-89c2-820b099e905a2
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD2ae07bb1-4383-4eec-89c2-820b099e905a2
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY2ae07bb1-4383-4eec-89c2-820b099e905a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-075-02680160075021 TUBE in 1 CARTON (68016-075-02) > 28.4 g in 1 TUBE1 tube2006-05-110000-00-00NoNoCurrent