FDA.reportPublic FDA data

Sion Biotext Bacitracin Zinc

Product NDC
68786-500
Requested package NDC
68786-500-01
11-digit product format
687860500
Labeler code
68786
Product ID
68786-500_376a6fcb-77cd-e812-e063-6294a90ac39c
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sion Biotext Medical Ltd
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-13
Substance
BACITRACIN ZINC
Active strength
500 [iU]/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
Sion Biotext Bacitracin Zinc
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/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
35056345-f325-99e8-e063-6294a90a2d7eAvailable 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
68786-500-01Sion Biotext Bacitracin Zinc28 g in 1 TUBEOINTMENT282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-500SION BIOTEXT BACITRACIN ZINC (BACITRACIN ZINC) OINTMENT [SION BIOTEXT MEDICAL LTD]1Current NDC, 1 package rows20250515_35056345-f325-99e8-e063-6294a90a2d7e.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 OintmentPSN35056345-f325-99e8-e063-6294a90a2d7e2
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD35056345-f325-99e8-e063-6294a90a2d7e2
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY35056345-f325-99e8-e063-6294a90a2d7e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68786-500-016878605000128 g in 1 TUBE (68786-500-01) 28 g2025-05-13NoNoCurrent