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
Label	Manufacturer	Effective date	Type
Ketoconazole Cream, 2%	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc.	2025-07-07	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%	NuCare Pharmaceuticals,Inc.	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole - Redpharm Drug	Redpharm Drug	2024-07-02	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL
Podiatrole - V2 Pharma, LLC	V2 Pharma, LLC	2023-01-06	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%	Preferred Pharmaceuticals, Inc.	2022-07-08	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole - Proficient Rx LP	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%	REMEDYREPACK INC.	2022-02-21	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%	NuCare Pharmaceuticals,Inc.	2021-07-28	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole - A-S Medication Solutions	A-S Medication Solutions	2021-06-16	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole - A-S Medication Solutions	A-S Medication Solutions	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%	NuCare Pharmaceuticals,Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%	NuCare Pharmaceuticals,Inc.	2017-08-31	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole Cream, 2%	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-02-16	HUMAN PRESCRIPTION DRUG LABEL
Ketoconazole - Rebel Distributors Corp	Rebel Distributors Corp	2011-01-17	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51672-1298-1	Ketoconazole	1 in 1 CARTON	CREAM	1		4
51672-1298-1	Ketoconazole	15 g in 1 TUBE	CREAM	15		4
51672-1298-2	Ketoconazole	1 in 1 CARTON	CREAM	1		4
51672-1298-2	Ketoconazole	30 g in 1 TUBE	CREAM	30		4
51672-1298-3	Ketoconazole	1 in 1 CARTON	CREAM	1		4
51672-1298-3	Ketoconazole	60 g in 1 TUBE	CREAM	60		4
51672-1298-2	Podiatrole	1 in 1 CARTON	CREAM		20 mg in 1g	1
51672-1298-2	Podiatrole	30 g in 1 TUBE	CREAM	60 g	20 mg in 1g	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-1298	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3	Current NDC, Legacy NDC, 6 package rows	20240210_39b85d6a-9133-42e6-b7f8-58f045e9b9f0.zip
51672-1298	PODIATROLE (KETOCONAZOLE 2% AND UREA 20%) KIT [V2 PHARMA, LLC]	1	Current NDC, Legacy NDC	20230219_ebd520d0-8069-490f-a0d7-356d1e7c3dfd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-1298-1	GM - Gram	51672-1298	d18efac5-493b-432d-a889-141da374f86f	1	2012-07-24
51672-1298-2	GM - Gram	51672-1298	ed634d09-35c4-49de-8c4a-140edac5f2aa	1	2012-07-24
51672-1298-3	GM - Gram	51672-1298	820a4a2a-778a-44fc-9192-b68f58617cf7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE CREAM [PREFERRED PHARMACEUTICALS, INC.]	2
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
Ketoconazole	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
Ketoconazole	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
butylated hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
Butylated Hydroxyanisole	INACTIVE INGREDIENT	REK4960K2U	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
isopropyl myristate	INACTIVE INGREDIENT	0RE8K4LNJS	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	KETOCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	KETOCONAZOLE 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 7 of 72 · 1,440 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	4cfe234c-49c0-18e8-e063-6294a90a0b1d	2026-07-02	Warnings	Exact identifier unii: R9400W927I
Fendall 1000 Pure Flow	PURIFIED WATER	Protective Industrial Products, Inc.	55a2f4da-bb1e-8ead-e063-6394a90af72e	2026-07-02	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Eyesaline Eyewash	STERILE EYESALINE EYEWASH	Protective Industrial Products, Inc.	55a290e8-8310-8be4-e063-6394a90abdce	2026-07-02	Warnings	Exact identifier unii: 059QF0KO0R
Eyesaline Emergency Eyewash	PURIFIED WATER	Protective Industrial Products, Inc.	55a261c2-725d-6765-e063-6294a90a3260	2026-07-02	Warnings	Exact identifier unii: 059QF0KO0R
Remodulin	TREPROSTINIL	United Therapeutics Corporation	6c80bb38-e8db-4138-9f0d-dbbf9c673185	2026-07-02	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Terpenicol Antifungal Cream	MICONAZOLE NITRATE	Blaine Labs Inc.	9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa	2026-07-01	Warnings	Exact identifier unii: VW4H1CYW1K
American Red Cross IPA 50% 6oz	AMERICAN RED CROSS IPA 50% 6OZ	TSM BRANDS LLC	29195bac-b096-ab8d-e063-6394a90a424a	2026-07-01	Warnings	Exact identifier unii: ND2M416302
American Red Cross 6oz, 50% Isopropyl Alcohol	AMERICAN RED CROSS 6 OZ, 50% ISOPROPYL ALCOHOL SPRAY	MY IMPORTS USA LLC	2929d580-cfff-e2b6-e063-6394a90a79aa	2026-07-01	Warnings	Exact identifier unii: ND2M416302
Terpenicol Antifungal Solution	MICONAZOLE NITRATE	Blaine Labs Inc.	f17ef2cd-5923-4df5-a7fe-aeef167e1e86	2026-07-01	Warnings	Exact identifier rxcui: 998525 unii: VW4H1CYW1K
Kopa Haiku Ringworm Treatment Cream	MICONAZOLE NITRATE 2%	Trovina Co. Ltd	52cef8ec-6578-5e80-e063-6294a90ab423	2026-06-30	Warnings	Exact identifier unii: VW4H1CYW1K
McKesson Alcohol Prep Pad	ISOPROPYL ALCOHOL	McKesson Medical-Surgical	a8e759f3-91b1-44ae-960a-3a6cd4f746ce	2026-06-30	Warnings	Exact identifier unii: ND2M416302
Tinted Isopropyl Alcohol	ISOPROPYL ALCOHOL	Medical Chemical Corporation	f3c1c8a3-6b34-46cf-845e-c89db8f096f1	2026-06-30	Warnings	Exact identifier unii: ND2M416302
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Medical Chemical Corporation	a04239d8-0fa9-4c00-aa81-d7a1242bc931	2026-06-30	Warnings	Exact identifier unii: ND2M416302
Ringworm Treatment Cream	MICONAZOLE NITRATE 2%	Beautivity LLC	4805462b-aec6-78fe-e063-6394a90ae066	2026-06-29	Warnings	Exact identifier unii: VW4H1CYW1K
Aosorw Antifungal Cream	MICONAZOLE NITRATE 2%	SpineStatus LLC	31f4b0eb-b8aa-7ccb-e063-6394a90ad981	2026-06-29	Warnings	Exact identifier unii: VW4H1CYW1K
Macks Dry n Clear	EAR DRYING AID	McKeon Products Inc	1ea1da54-2412-c25c-e063-6294a90aa264	2026-06-26	Warnings	Exact identifier application number: M014 unii: ND2M416302
Lights Alcohol Wipes	ISOPROPYL ALCOHOL	Lights Medical Manufacture Co., Ltd.	f9601021-4c52-4b48-96c1-b25fe8fef8b1	2026-06-26	Warnings	Exact identifier unii: ND2M416302
Equate Swimmers Instant Ear Dry	EQUATE SWIMMERS INSTANT EAR DRY	Walmart Stores, Inc	76b58a7a-48cf-866c-e053-2a91aa0a7e63	2026-06-26	Warnings	Exact identifier application number: M014 unii: ND2M416302
Lights Medium Alcohol	ISOPROPYL ALCOHOL	Lights Medical Manufacture Co., Ltd.	873e0c9d-e0aa-44bb-a1f4-447458479023	2026-06-25	Warnings	Exact identifier unii: ND2M416302
Chemstat	GLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,	Energique, Inc.	2e361b50-9268-4053-b13c-93af64549848	2026-06-25	Warnings	Exact identifier unii: 8CRQ2TH63M unii: Q40Q9N063P unii: LKG8494WBH unii: 2KR89I4H1Y

Reported adverse events (FAERS/openFDA)#

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