FDA.reportPublic FDA data

Aftate Bacitracin Zinc

Manufacturer
Sabel Med LLC
Effective date
2016-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:49

Label at a glance#

ProductAftate Bacitracin Zinc
Active ingredientBACITRACIN ZINC
Label structure8 sections

Label contents#

Full prescribing information#

Warnings section

warning sectionwarning section

INACTIVE INGREDIENT SECTION

inactivesinactives

OTC - PURPOSE SECTION

purposepurpose

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reachKeep out of reach

OTC - ACTIVE INGREDIENT SECTION

active ingredientactive ingredient

DOSAGE & ADMINISTRATION SECTION

dosagedosage

INDICATIONS & USAGE SECTION

UsesUses

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tube-principle displaytube-principle display

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN1
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD1
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
70356-125-012020-01-31C16284748780-19d75b9d1-2682-f424-e053-dadaa90a57ceBacitracin Zinc Ointment 1 oz (28g) tube Bacitracin Zinc Ointment 0.5 oz (14g) tube
70356-125-052020-01-31C16284748780-19d75b9d1-2682-f424-e053-dadaa90a57ceBacitracin Zinc Ointment 1 oz (28g) tube Bacitracin Zinc Ointment 0.5 oz (14g) tube

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70356-125-01Aftate Bacitracin Zinc28 g in 1 TUBEOINTMENT281
70356-125-05Aftate Bacitracin Zinc14 g in 1 TUBEOINTMENT141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70356-125AFTATE BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [SABEL MED LLC]1Legacy NDC, 2 package rows20160501_2b390b06-cac3-4daa-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70356-12570356-125-01, 70356-125-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
LIGHT MINERAL OILN6K5787QVPIACT
MINERAL OILT5L8T28FGPIACT
BACITRACIN ZINC89Y4M234ESACTIM

Source Document#

Source XML

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
2b390b06-cac4-4daa-e054-00144ff8d46c2b390b06-cac3-4daa-e054-00144ff8d46c2016-03-31WarningsExact identifier
spl id: 2b390b06-cac4-4daa-e054-00144ff8d46c
spl set id: 2b390b06-cac3-4daa-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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