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 6 of 72 · 1,440 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biopure 70% Isopropyl Alcohol Wipe	ISOPROPYL ALCOHOL, WIPE	QUEST USA CORP	3a7932c4-6f90-a008-e063-6294a90aa769	2026-07-19	Warnings	Exact identifier unii: ND2M416302
FUNGAL NAIL TREATMENT kit .cream.	PSEUDOLARIX AMABILIS BARK 1%	GETHSEMANE BRANCH CORPORATION	56c9d9fa-09ad-e26a-e063-6394a90a0ed9	2026-07-17	Warnings	Exact identifier unii: 6DC9Q167V3
2% MICONAZOLE NITRATE ANTIFUNGAL Cream	2% MICONAZOLE NITRATE ANTIFUNGAL CREAM	GUANGZHOU YUSONG FINE CHEMICLS Co., Ltd	56b54359-db21-b8b4-e063-6394a90a6f8c	2026-07-16	Warnings	Exact identifier unii: VW4H1CYW1K
DRAVYNOR BALANITIS RELIEF Cream	MICONAZOLE NITRATE 2% BALANITIS RELIEF CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b76a52-0743-4fe6-e063-6294a90a98a8	2026-07-16	Warnings	Exact identifier unii: VW4H1CYW1K
Eyewash Station Additive Concentrate	CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL	Global Equipment Company	bc93a1e8-aa3c-6735-e053-2995a90ad6e8	2026-07-16	Warnings	Exact identifier unii: 6DC9Q167V3
Revitalize Energizing Eye Drops	NAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOL	Revitalize Energy Inc.	518aac87-1642-4b2f-bca1-b74d21261eea	2026-07-16	Warnings	Exact identifier unii: 6DC9Q167V3
Antifungal Ringworm Treatment Cream	MICONAZOLE NITRATE	Yunqi Cosmetics (Shenzhen) Co., Ltd	56a2ceea-c4c0-c30c-e063-6394a90a0e6a	2026-07-15	Warnings	Exact identifier unii: VW4H1CYW1K
Medi-First Antifungal Cream Miconazole Cream	MICONAZOLE	Unifirst First Aid Corporation	56a51b75-9c23-bcd2-e063-6394a90a9b12	2026-07-15	Warnings	Exact identifier unii: VW4H1CYW1K
UREDEX	UREA	Blue Heron Pharmaceuticals, LLC	0e4d7b03-527f-4cff-9154-7e5e485a8f80	2026-07-13	Warnings, Adverse reactions	Exact identifier rxcui: 198886 unii: 8W8T17847W
Alcohol Cleansing Wipe	ISOPROPYL ALCOHOL	Hubei Fanjian Medical Product Co.,Ltd	1607fb06-826b-42bb-986e-0023a1b078f3	2026-07-10	Warnings	Exact identifier unii: ND2M416302
Miconazole 7	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	85a52081-d9cc-44f0-a8d3-851a45c4eb10	2026-07-08	Warnings	Exact identifier unii: VW4H1CYW1K
Antifungal Cream	ANTIFUNGAL	Preferred Pharmaceuticals Inc.	c6098653-351a-449f-9b1a-0c617074f2b9	2026-07-08	Warnings	Exact identifier unii: VW4H1CYW1K
Freskaro Ear Drops for Swimmers	FRESKARO EAR DROPS FOR SWIMMERS	Pharma Nobis, LLC	4f724d85-cd38-41da-e063-6394a90a9fd7	2026-07-08	Warnings	Exact identifier application number: M014 unii: ND2M416302
Folliculitis Treatment Cream	MICONAZOLE NITRATE 2%	Guangxi Keyun E-commerce Co., Ltd.	5625652a-193d-0318-e063-6294a90a56f3	2026-07-08	Warnings	Exact identifier unii: VW4H1CYW1K
Miconazole 7	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	99c66cbd-7063-4b4c-b827-4f2fcb6ed67f	2026-07-08	Warnings	Exact identifier unii: VW4H1CYW1K
70%	ISOPROPYL ALCOHOL	Save-A-Lot Food Stores Ltd	a592326c-c062-4ebf-b8dd-83f7e6f2f22b	2026-07-07	Warnings, Adverse reactions	Exact identifier unii: ND2M416302
KETOCONAZOLE	KETOCONAZOLE	PD-Rx Pharmaceuticals, Inc.	f162e616-21b4-49b1-b437-15e21001a6f0	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: R9400W927I
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)	NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)	Reedfresh Co., LTD	55d703ca-ff9d-0dbc-e063-6294a90ab6b1	2026-07-05	Warnings	Exact identifier unii: 059QF0KO0R
Eyesaline Eyewash Concentrate	PURIFIED WATER	Protective Industrial Products, Inc.	558e5926-9027-d3f6-e063-6294a90ab121	2026-07-02	Warnings	Exact identifier unii: 059QF0KO0R
Fendall 2000 Pure Flow	PURIFIED WATER	Protective Industrial Products, Inc.	55a1d07e-0006-0c75-e063-6394a90a7acc	2026-07-02	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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