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 12 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC13c1f2df-ba52-45e0-8868-a7518e9cdb552025-04-07WarningsExact identifier
application number: M004
Honestly Battleborn First Aid for Real ManTETRACYCLINE HYDROCHLORIDEHONESTLY LLC93a6e02e-9f4b-4821-afa2-2029769f30882025-04-07WarningsExact identifier
application number: M004
burn gel 01MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILCosmuses Cosmetics (Ningbo) Co., Ltd.3227bdc9-9323-68eb-e063-6294a90a29d22025-04-06WarningsExact identifier
application number: M004
Vitastem ULTRABACITRACIN ZINCViaDerma Distribution, Incfd96cc09-8522-44a5-b034-0d30e532410d2025-04-03WarningsExact identifier
application number: M004
Vitastem Ultra First Aid AntibioticBACITRACIN ZINCViaderma Distribution Ince6986bf9-22ea-4484-a709-27bc91c9058d2025-03-18WarningsExact identifier
application number: M004
Redicare Triple Antibiotic First AidTRIPLE ANTIBIOTIC FIRST AID OINTMENTRedicare LLC9468979d-446e-e4be-e053-2995a90a3f212025-03-05WarningsExact identifier
application number: M004
Neosporin OriginalBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATEKenvue Brands LLC0ad21575-0e2d-24c2-e063-6394a90a616e2025-02-21WarningsExact identifier
application number: M004
The Life Safety Pro Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.64a7331f-98a6-4052-85b9-695c83b3bd162025-02-19WarningsExact identifier
application number: M004
VitastemTETRACYCLINE HYDROCHLORIDEViaDerma Distribution, Inc.a6630858-7038-425f-8a75-bb25f36a0dbe2025-02-18WarningsExact identifier
application number: M004
Sheffield Triple AntibioticBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATESheffield Pharmaceuticals LLC1aa95046-c1f7-4fc7-acac-839065d998f62025-02-17WarningsExact identifier
application number: M004
EquateBACITRACIN ZINC ANTIBIOTIC OINTMENTWalmart Inc.20908780-8803-4e19-e063-6394a90aab872025-02-01WarningsExact identifier
application number: M004
Tetracyte Topical Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEVIADERMA DISTRIBUTION INC0961b097-ba41-40c2-aaec-dd291841bf092025-01-30WarningsExact identifier
application number: M004
AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEWelly Health PBC9446375d-4bb4-4bb1-bdc2-c18e995bfe262025-01-29WarningsExact identifier
application number: M004
FAK Care4 Bus and School Yellow ORM DBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.3b5d07c6-bda2-4bc7-89b8-88280d11ed742025-01-22WarningsExact identifier
application number: M004
Members Mark Alcohol Prep Pads, SterileISOPROPYL ALCOHOLSam's Club West Inc.13001877-ae90-40be-899d-fb38f3a38b122025-01-22WarningsExact identifier
application number: M004
Equate Antibiotic Plus Pain, Itch, Scar ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMart2b743271-4f58-4ba1-a04c-560f7f8a547e2025-01-16WarningsExact identifier
application number: M004
Equate Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEWalMarte08b427f-d070-4521-ad3c-faf2955317912025-01-16WarningsExact identifier
application number: M004
NATUREPLEX ANTIBIOTICBACITRACIN ZINC AND POLYMYXIN B SULFATENatureplex LLC86ea3452-c810-4c9a-9f52-bcb0688020f92025-01-15WarningsExact identifier
application number: M004
Balma Septic Antiseptic Hand WashBENZALKONIUM CHLORIDERochester Midland Corporation1b8e0a27-dcdd-4d07-b0f2-55cf74a9b5282025-01-10WarningsExact identifier
application number: M004
LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380CHLOROXYLENOLABC Compounding Co., Inc.efa3938f-64de-77ba-e053-2a95a90ac8402025-01-10WarningsExact 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