FDA.reportPublic FDA data

Zapotol Bacitracin

Product NDC
59428-135
11-digit product format
594280135
Labeler code
59428
Product ID
59428-135_41c89cd8-cf22-fc47-e063-6394a90a07de
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
CREAM
Route
TOPICAL
Labeler
Zapatol Corp.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-08-06
Substance
BACITRACIN
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
Zapotol Bacitracin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
58H6RWO52IInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8704895-8819-49ac-8baa-5b97be1d00aaAvailable 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
59428-135-14Zapotol Bacitracin14 g in 1 TUBECREAM145
59428-135-14Zapotol Bacitracin1 in 1 PACKAGECREAM15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACINACTIVE INGREDIENT58H6RWO52IZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]1
BACITRACINACTIVE MOIETY58H6RWO52IZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]1
ALOE VERA WHOLEINACTIVE INGREDIENTKIZ4X2EHYXZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59428-135ZAPOTOL BACITRACIN (BACITRACIN) CREAM [ZAPATOL CORP.]4Current NDC, Legacy NDC, 2 package rows20241226_c8704895-8819-49ac-8baa-5b97be1d00aa.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 15 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neosporin Plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC32302dcd-f3f1-408b-ae5f-e7d8b666f68f2024-11-13WarningsExact identifier
application number: M004
NEOSPORIN Plus BURN RELIEFBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC3caa7fd1-bd66-427e-a6c0-1b137b2050892024-11-13WarningsExact identifier
application number: M004
Simply Neosporin First Aid AntibioticBACITRACIN ZINC AND POLYMYXIN B SULFATEKenvue Brands LLC68bfecea-095f-4d3f-b077-d86e1b9f1faa2024-11-13WarningsExact identifier
application number: M004
Triple Antibiotic and Burn ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDECVS Pharmacyfdc510b8-f3ad-4bd6-a8d0-1b81e9f30e132024-11-13WarningsExact identifier
application number: M004
BACITRACINBACITRACINALLIED TRADE LINK LLC253e5b98-c64f-3226-e063-6294a90a93522024-11-12WarningsExact identifier
application number: M004
TRIPLET ANTIBIOTICTRIPLET ANTIBIOTICALLIED TRADE LINK LLC26bd5ba4-264b-2a28-e063-6394a90ada802024-11-12WarningsExact identifier
application number: M004
basic care first aid antibiotic and burn reliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEAmazon.com Services LLC0df4c44d-6912-4db9-a703-a82da4c8ae762024-11-11WarningsExact identifier
application number: M004
SUPER SENSITIVE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTY7d4a5b21-82d2-4904-9577-4a9b2579076e2024-11-08WarningsExact identifier
application number: M004
dg health triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLDolgencorp, LLC4c97dada-966f-4de8-b5d9-e939cb456aea2024-11-06WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BA-S Medication Solutionsde07139e-ece9-424b-8468-f5ed4bbb2b2b2024-11-06WarningsExact identifier
application number: M004
good sense triple antibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLL. Perrigo Companye9e913d8-8ec8-4465-ad3a-b524f6710a0f2024-11-06WarningsExact identifier
application number: M004
EUCALYPTUS EASE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTY09d77591-9472-4771-9090-3390bddf788a2024-11-06WarningsExact identifier
application number: M004
Triple AntibioticPOLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATEA-S Medication Solutionse115d413-e41c-4e43-8184-493d64dfcd9f2024-11-06WarningsExact identifier
application number: M004
LEMON MYRTLE HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYf341b24c-9466-42f4-98fe-d1a1225919152024-11-06WarningsExact identifier
application number: M004
BacitracinBACITRACINA-S Medication Solutions00747e3a-389c-46bc-b6b9-9b3d1d98dbcf2024-11-06WarningsExact identifier
application number: M004
Signature Care Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLSafeway46db4b66-85a2-47fc-a643-df6477e2ddff2024-11-06WarningsExact identifier
application number: M004
CALMING HAND SANITIZERALCOHOLORGANIC & SUSTAINABLE BEAUTYffcbe34d-3c53-47f9-9e4a-b5448afbbd5d2024-11-05WarningsExact identifier
application number: M004
Antibiotic, Pain and ScarBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCLCVS Pharmacy8bb6cb64-103f-454a-95ad-c2c56b9cf71a2024-11-05WarningsExact identifier
application number: M004
BACITRACINBACITRACINMeijer Distribution Inc029e7150-1b9a-47c9-90bd-5f8bcd21365c2024-10-29WarningsExact identifier
application number: M004
SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEFPOLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEA-S Medication Solutions01131ba6-6d5b-4710-bec3-ba1769c08c792024-10-22WarningsExact identifier
application number: M004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59428-135-14594280135141 TUBE in 1 PACKAGE (59428-135-14) / 14 g in 1 TUBE1 tube2016-10-130000-00-00NoNoCurrent