FDA.reportPublic FDA data

Sheffield Bacitracin Zinc

Product NDC
11527-163
11-digit product format
115270163
Labeler code
11527
Product ID
11527-163_9a273a49-de7b-4b60-9d38-b4b0a57c4eb3
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sheffield Pharmaceuticals LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-25
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
Sheffield 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
0f446f48-f55d-4de7-b447-285d7a329c84Available 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
11527-163-15Sheffield Bacitracin Zinc1 in 1 CARTONOINTMENT16
11527-163-15Sheffield Bacitracin Zinc15 g in 1 TUBEOINTMENT156
11527-163-30Sheffield Bacitracin Zinc30 g in 1 TUBEOINTMENT306
11527-163-30Sheffield Bacitracin Zinc1 in 1 PACKAGEOINTMENT16
11527-163-51Sheffield Bacitracin Zinc1 in 1 CARTONOINTMENT16
11527-163-51Sheffield Bacitracin Zinc14 g in 1 TUBEOINTMENT146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-163-51GM - Gram11527-16304d23fc0-eeda-480f-85a6-67853f626ab912022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ESSHEFFIELD BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
BacitracinACTIVE MOIETY58H6RWO52ISHEFFIELD BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2
PetrolatumINACTIVE INGREDIENT4T6H12BN9USHEFFIELD BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-163SHEFFIELD BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [SHEFFIELD PHARMACEUTICALS LLC]6Current NDC, Legacy NDC, 6 package rows20231121_0f446f48-f55d-4de7-b447-285d7a329c84.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 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
application number: M004
GENUINE FIRST AID AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.23abfe12-5b50-4b49-878e-4fcdb6c341fd2023-10-19WarningsExact identifier
application number: M004
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 OintmentPSN0f446f48-f55d-4de7-b447-285d7a329c846
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD0f446f48-f55d-4de7-b447-285d7a329c846
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY0f446f48-f55d-4de7-b447-285d7a329c846

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-163-15115270163151 TUBE in 1 CARTON (11527-163-15) / 15 g in 1 TUBE1 tube2020-12-220000-00-00NoNoCurrent
11527-163-30115270163301 TUBE in 1 PACKAGE (11527-163-30) / 30 g in 1 TUBE1 tube2020-12-220000-00-00NoNoCurrent
11527-163-51115270163511 TUBE in 1 CARTON (11527-163-51) / 14 g in 1 TUBE1 tube2012-09-250000-00-00NoNoCurrent