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

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 1 of 22 · 430 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dealmed Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEDealmed Medical Supplies, LLC.b3f1e834-4e8f-49f6-af0d-38097ae4f9282026-08-13WarningsExact identifier
application number: M004
First Aid Antibiotic and Burn ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDEAmazon.com Services LLC3459a453-0a94-4122-adad-bb120daecd9e2026-08-12WarningsExact identifier
application number: M004
Dealmed BacitracinBACITRACIN ZINCDealmed Medical Supplies, LLC.26f282b5-b3af-4049-93f6-659071be721d2026-08-12WarningsExact identifier
application number: M004
triple antibiotic pain reliefBACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCLWalgreen Companyf0fa2822-02a2-49e5-ad47-aa7e9cc2da712026-08-11WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCA-S Medication Solutions9fcda25b-3940-4028-a8ee-6e6c6e4b2a532026-08-07WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATESalado Sales, Inc52e275d3-88c9-47f1-8dcf-68445c7be4a72026-08-05WarningsExact identifier
application number: M004
Wound Wash Antiseptic Saline with Benzalkonium ChlorideWOUND WASH ANTISEPTIC SALINE WITH BENZALKONIUM CHLORIDENeilMed Pharmaceuticals, Inc.55a1fc63-2527-4033-e054-00144ff8d46c2026-08-05WarningsExact identifier
application number: M004
ProcureTriple Antibiotic Triple AntibioticBACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN BTWIN MED, LLC71592776-407b-489c-8cdb-8c0573d844f82026-08-03WarningsExact identifier
application number: M004
procureFirst Aid Antibio First Aid AntibioticBACITRACINTWIN MED, LLC8d19e931-99c4-47b8-b7ec-94c16535166f2026-08-03WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVive Health LLC236c62bf-3de0-0b3e-e063-6394a90ad6c62026-07-21WarningsExact identifier
application number: M004
TRIPLE ANTIBIOTICBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEVive Health LLC21b38b00-1e64-83d8-e063-6294a90a07bd2026-07-21WarningsExact identifier
application number: M004
DERMFREE Triple AntibioticTRIPLE ANTIBIOTICJiangxi Yudexi Pharmaceutical Co., LTD4a5a5603-3478-5f7a-e063-6294a90acc402026-07-21WarningsExact identifier
application number: M004
BacitracinBACITRACIN ZINCPreferred Pharmaceuticals Inc.e094566b-3b80-45ac-be73-54c798bbb7632026-07-15WarningsExact identifier
application number: M004
CAREALL BacitracinBACITRACIN ZINCNew World Imports, Inc560ba2ca-ad0f-9202-e063-6294a90aaefd2026-07-14WarningsExact identifier
application number: M004
CareALL Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENew World Imports, Inc561bf89c-ca78-d7e4-e063-6394a90a983f2026-07-14WarningsExact identifier
application number: M004
Good Sense First Aid AntibioticBACITRACIN ZINC, NEOMYCIN, POLYMYXIN BL. Perrigo Company3eadd35c-3df2-4e46-b76d-a6e5378959172026-07-10WarningsExact identifier
application number: M004
CareALL Triple Antibiotic plus Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCLNew World Imports, Inc561c1e51-19f4-90ce-e063-6294a90a5f9b2026-07-08WarningsExact identifier
application number: M004
Ever Ready First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVER READY FIRST AIDee1ad6d7-e9c1-2b20-e053-2995a90a33662026-07-03WarningsExact identifier
application number: M004
Single Antibiotic with bacitracinBACITRACIN ZINCSafetec of America4ae9a105-e3f9-4015-8844-085e0b34cdb62026-06-25WarningsExact identifier
application number: M004
Antibacterial Hand Wipes (0.13% Benzalkonium Chloride)BENZALKONIUM CHLORIDEEleeo Brands LLC551baf59-39b9-e994-e063-6294a90a65e62026-06-25WarningsExact 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