FDA.reportPublic FDA data

Bacitracin Zinc

Product NDC
87236-001
Requested package NDC
87236-001-01
11-digit product format
872360001
Labeler code
87236
Product ID
87236-001_53c0eec1-bde8-470f-e063-6294a90a29f0
Type
HUMAN OTC DRUG
Nonproprietary name
First Aid Antibiotic
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aldermed Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-01
Substance
BACITRACIN ZINC
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Bacitracin Zinc
Listing expiration
2027-12-31

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
7f4bff4f-588d-4e45-8aa3-f95b4d746f25Available 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
87236-001-01Bacitracin Zinc1 in 1 CARTONOINTMENT14
87236-001-01Bacitracin Zinc28.4 g in 1 TUBEOINTMENT28.44
87236-001-09Bacitracin Zinc0.9 g in 1 PACKETOINTMENT0.94
87236-001-14Bacitracin Zinc1 in 1 CARTONOINTMENT14
87236-001-14Bacitracin Zinc14.2 g in 1 TUBEOINTMENT14.24
87236-001-15Bacitracin Zinc425 g in 1 JAROINTMENT4254
87236-001-44Bacitracin Zinc0.9 g in 1 PACKETOINTMENT0.94
87236-001-44Bacitracin Zinc144 in 1 CARTONOINTMENT1444

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 OintmentPSN7f4bff4f-588d-4e45-8aa3-f95b4d746f254
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD7f4bff4f-588d-4e45-8aa3-f95b4d746f254
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY7f4bff4f-588d-4e45-8aa3-f95b4d746f254

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87236-001-01872360001011 TUBE in 1 CARTON (87236-001-01) / 28.4 g in 1 TUBE1 tube2025-11-01NoNoCurrent