FDA.reportPublic FDA data

NDC 51672-1298-01 - Ketoconazole

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51672-1298
Requested NDC
51672-1298-01
Package NDCs from labels
51672-1298-1, 51672-1298-2, 51672-1298-3, 51672-1298-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ketoconazole Cream, 2%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-07HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%NuCare Pharmaceuticals,Inc.2024-12-26HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole - Redpharm DrugRedpharm Drug2024-07-02HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
Podiatrole - V2 Pharma, LLCV2 Pharma, LLC2023-01-06HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%Preferred Pharmaceuticals, Inc.2022-07-08HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole - Proficient Rx LPProficient Rx LP2022-04-01HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%REMEDYREPACK INC.2022-02-21HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%NuCare Pharmaceuticals,Inc.2021-07-28HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole - A-S Medication SolutionsA-S Medication Solutions2021-06-16HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole - A-S Medication SolutionsA-S Medication Solutions2021-06-15HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%NuCare Pharmaceuticals,Inc.2021-02-11HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%NuCare Pharmaceuticals,Inc.2017-08-31HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%Dispensing Solutions, Inc. | PSS World Medical, Inc.2012-02-16HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole - Rebel Distributors CorpRebel Distributors Corp2011-01-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1298-1Ketoconazole1 in 1 CARTONCREAM14
51672-1298-1Ketoconazole15 g in 1 TUBECREAM154
51672-1298-2Ketoconazole1 in 1 CARTONCREAM14
51672-1298-2Ketoconazole30 g in 1 TUBECREAM304
51672-1298-3Ketoconazole1 in 1 CARTONCREAM14
51672-1298-3Ketoconazole60 g in 1 TUBECREAM604
51672-1298-2Podiatrole1 in 1 CARTONCREAM20 mg in 1g1
51672-1298-2Podiatrole30 g in 1 TUBECREAM60 g20 mg in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1298KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 6 package rows20240210_39b85d6a-9133-42e6-b7f8-58f045e9b9f0.zip
51672-1298PODIATROLE (KETOCONAZOLE 2% AND UREA 20%) KIT [V2 PHARMA, LLC]1Current NDC, Legacy NDC20230219_ebd520d0-8069-490f-a0d7-356d1e7c3dfd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1298-1GM - Gram51672-1298d18efac5-493b-432d-a889-141da374f86f12012-07-24
51672-1298-2GM - Gram51672-1298ed634d09-35c4-49de-8c4a-140edac5f2aa12012-07-24
51672-1298-3GM - Gram51672-1298820a4a2a-778a-44fc-9192-b68f58617cf712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
KetoconazoleACTIVE INGREDIENTR9400W927IKETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
KetoconazoleACTIVE MOIETYR9400W927IKETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UKETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNKETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSKETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MKETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HKETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XKETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YKETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RKETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]2
KetoconazoleACTIVE INGREDIENTR9400W927IKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
KetoconazoleACTIVE INGREDIENTR9400W927IKETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
KetoconazoleACTIVE INGREDIENTR9400W927IKETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
KetoconazoleACTIVE MOIETYR9400W927IKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
KetoconazoleACTIVE MOIETYR9400W927IKETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
KetoconazoleACTIVE MOIETYR9400W927IKETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UKETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UKETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
Butylated HydroxyanisoleINACTIVE INGREDIENTREK4960K2UKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNKETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNKETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSKETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSKETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MKETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MKETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HKETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HKETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XKETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XKETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YKETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YKETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RKETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
waterINACTIVE INGREDIENT059QF0KO0RKETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RKETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1

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 5 of 72 · 1,440 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ADVOCATE Sterile Alcohol Prep PadsISOPROPYL ALCOHOLPHARMA SUPPLY, INCa87dd40d-a9b1-4bb5-acc2-2d00abc2034a2026-07-30WarningsExact identifier
unii: ND2M416302
cardae FOLLICULITIS CreamMICONAZOLE NITRATE 2% FOLLICULITIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.57e0be6a-3141-f3b6-e063-6394a90a15202026-07-30WarningsExact identifier
unii: VW4H1CYW1K
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
70% Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions57ac6fef-21de-e214-e063-6394a90a6c9e2026-07-28WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOL4 Visions LLC57acc1ff-2564-1e61-e063-6394a90a3c912026-07-28WarningsExact identifier
unii: ND2M416302
Pharma care IPA WipesISOPROPYL ALCOHOLEnviro Specialty Chemicals Inc26ce919a-1765-4b44-9114-24ea7383a9872026-07-24WarningsExact identifier
unii: ND2M416302
Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLCVS Pharmacy49003aac-184c-ae33-e063-6294a90a29c02026-07-24WarningsExact identifier
unii: LKG8494WBH
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
DOCTOR INKS IPA WIPESISOPROPYL ALCOHOLEnviro Specialty Chemicals Incf65f0ec4-fa2c-487d-a8cc-41cbb8c140a42026-07-24WarningsExact identifier
unii: ND2M416302
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC54dc3642-0b7a-07d8-e063-6294a90ad5562026-07-22WarningsExact identifier
application number: M014
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.5738a502-c5ab-21b0-e063-6294a90a20a72026-07-22WarningsExact identifier
unii: ND2M416302
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC55057e1b-b11e-51b9-e063-6394a90a9fca2026-07-22WarningsExact identifier
application number: M014
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
unii: ND2M416302
KeepGoing Alcohol Prep PadISOPROPYL ALCOHOLJ&A Digital Inc.5d1e776b-4027-4d05-b02f-8a2701d7bc7a2026-07-22WarningsExact identifier
unii: ND2M416302
PROVEN MEDICAL TESTING Alcohol Prep PadsISOPROPYL ALCOHOLProven Medical Testing, LLC21e0f7ea-e73e-4461-ab2b-50d456e1d70d2026-07-22WarningsExact identifier
unii: ND2M416302
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AVENASTER FUNGAL NAIL CARE DUO SET (DAY)UREA 20% FUNGAL NAIL CARE DUO SET (DAY)Jiangxi Yudexi Pharmaceutical Co., LTD51ebecc4-391c-ff08-e063-6294a90a20ed2026-07-20WarningsExact identifier
unii: 8W8T17847W
Charmpoo Antifungal CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMJiangxi Yudexi Pharmaceutical Co., LTD4ac347b5-d21b-cc9a-e063-6394a90a54962026-07-20WarningsExact identifier
unii: VW4H1CYW1K

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.