FDA.reportPublic FDA data

Premier Value Bacitracin Zinc

Product NDC
68016-107
Requested package NDC
68016-107-01
11-digit product format
680160107
Labeler code
68016
Product ID
68016-107_29b719b2-ad3c-951a-e063-6294a90a494d
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Pharmacy Value Alliance LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-16
Substance
BACITRACIN ZINC
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

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Premier Value Bacitracin Zinc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1366116Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
99d789be-aa85-0917-e053-2a95a90acd13Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-05-09Premier Value Bacitracin Zinc Ointment USP
2023-01-30Premier Value Bacitracin Zinc Ointment USP
2021-08-10Premier Value Bacitracin Zinc Ointment USP
2021-01-29Premier Value Bacitracin Zinc Ointment USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-107-01Premier Value Bacitracin Zinc28 g in 1 TUBEOINTMENT284
68016-107-01Premier Value Bacitracin Zinc1 in 1 BOXOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-107PREMIER VALUE BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [PHARMACY VALUE ALLIANCE LLC]4Current NDC, Legacy NDC, 2 package rows20241222_99d789be-aa85-0917-e053-2a95a90acd13.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 22 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERLIT CARE Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.f4921508-c32f-426f-a2f0-16c3acbd47132023-10-14WarningsExact identifier
application number: M004
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
application number: M004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN99d789be-aa85-0917-e053-2a95a90acd134
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD99d789be-aa85-0917-e053-2a95a90acd134
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY99d789be-aa85-0917-e053-2a95a90acd134

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-107-01680160107011 TUBE in 1 BOX (68016-107-01) / 28 g in 1 TUBE1 tube2019-12-160000-00-00NoNoCurrent