NDC 51672-1289-01 - Nystatin

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: 51672-1289
Requested NDC: 51672-1289-01
Package NDCs from labels: 51672-1289-1, 51672-1289-2, 51672-1289-01
Manufacturer: Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. | Taro Pharmaceutical Industries Ltd.
Effective date: 2025-07-03
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Nystatin Cream USP, 100,000 units per gram	Sun Pharmaceutical Industries, Inc. \| Sun Pharma Canada Inc. \| Taro Pharmaceutical Industries Ltd.	2025-07-03	HUMAN PRESCRIPTION DRUG LABEL
Nystatin Cream USP, 100,000 units per gram	NuCare Pharmaceuticals,Inc.	2025-02-10	HUMAN PRESCRIPTION DRUG LABEL
NYSTATIN - DIRECT RX	DIRECT RX	2025-01-20	HUMAN PRESCRIPTION DRUG LABEL
Nystatin Cream USP, 100,000 units per gram	NuCare Pharmaceuticals,Inc.	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL
Nystatin Cream USP, 100,000 units per gram	Preferred Pharmaceuticals Inc. \| Preferred PharmaceuticalsInc.	2024-07-23	HUMAN PRESCRIPTION DRUG LABEL
Nystatin - Proficient Rx LP	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL
Nystatin Cream USP, 100,000 units per gram	Preferred Pharmaceuticals Inc.	2019-01-30	HUMAN PRESCRIPTION DRUG LABEL
NYSTATIN - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-05-10	HUMAN PRESCRIPTION DRUG LABEL
Nystatin - Rebel Distributors Corp	Rebel Distributors Corp	2010-10-08	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51672-1289-1	Nystatin	15 g in 1 TUBE	CREAM	15	6
51672-1289-1	Nystatin	1 in 1 CARTON	CREAM	1	6
51672-1289-2	Nystatin	1 in 1 CARTON	CREAM	1	6
51672-1289-2	Nystatin	30 g in 1 TUBE	CREAM	30	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-1289	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	5	Current NDC, Legacy NDC, 4 package rows	20230126_4d845b3f-ca26-4c47-b424-b6d783cc10e5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-1289-1	GM - Gram	51672-1289	38067616-cd05-468d-a844-b2ec0513e43f	1	2012-07-24
51672-1289-2	GM - Gram	51672-1289	4f7b2183-b586-49ab-9a71-4e40d5479cb9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Nystatin	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
Nystatin	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
algeldrate	INACTIVE INGREDIENT	03J11K103C	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
ceteareth-15	INACTIVE INGREDIENT	867H4YOZ8Z	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
sorbitol	INACTIVE INGREDIENT	506T60A25R	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	3
NYSTATIN	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
Nystatin	ACTIVE INGREDIENT	BDF1O1C72E	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
NYSTATIN	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
Nystatin	ACTIVE MOIETY	BDF1O1C72E	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
ALGELDRATE	INACTIVE INGREDIENT	03J11K103C	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
ALGELDRATE	INACTIVE INGREDIENT	03J11K103C	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
CETEARETH-12	INACTIVE INGREDIENT	7V4MR24V5P	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
CETEARETH-15	INACTIVE INGREDIENT	867H4YOZ8Z	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	NYSTATIN 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 47 of 147 · 2,926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunscreen Cream	ZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%	Foshan Sugar Max Cosmetics CO.,Ltd	460f0ca0-9440-9a6e-e063-6394a90a33b3	2025-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
Non Tinted Facial Mineral Protectant	TITANIUM DIOXIDE, ZINC OXIDE	EUROPEAN SKIN AND MASSAGE STUDIO	3766496f-231c-f98c-e063-6294a90aae08	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Facial Mineral Protectant	TITANIUM DIOXIDE, ZINC OXIDE	EUROPEAN SKIN AND MASSAGE STUDIO	3766b0d8-20e6-a227-e063-6294a90af4da	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen Broad Spectrum SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	WECARE FRISCO PLLC	374f866d-eb52-61e3-e063-6394a90a77c7	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Lip Protection	TITANIUM DIOXIDE, ZINC OXIDE	WECARE FRISCO PLLC	3750c23d-c3f8-fac3-e063-6394a90a135e	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	KATHY JONES AESTHETHICS LLC	37dab729-5988-5eba-e063-6294a90ac6b7	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tory Sullivan, M.D., P.A.	36241e60-f02a-50a7-e063-6394a90a6390	2025-12-16		Exact identifier unii: 15FIX9V2JP
UV Defense Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC	365e09a8-308b-b753-e063-6394a90ae9e5	2025-12-16		Exact identifier unii: 15FIX9V2JP
UV Defense Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	CCLEAR SOLUTIONS ACNE & SKIN CARE CLINIC	365e2498-7df2-f22c-e063-6294a90ac6ab	2025-12-16		Exact identifier unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen non tinted	TITANIUM DIOXIDE, ZINC OXIDE	ATHENA PLASTIC SURGERY	3b3bf5a6-33ec-0255-e063-6294a90ac96a	2025-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen, tinted	TITANIUM DIOXIDE, ZINC OXIDE	ATHENA PLASTIC SURGERY	3b3cba2e-acc6-a2df-e063-6294a90abf71	2025-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
UV Protection Veil Mineral Sunscreen, tinted	TITANIUM DIOXIDE, ZINC OXIDE	ATHENA PLASTIC SURGERY	3b3c757f-6581-4978-e063-6294a90a6173	2025-12-16	Warnings	Exact identifier unii: 15FIX9V2JP
Virgo SOL Primer Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ULTRAVIOLET SKINCARE LLC	369d4f43-8c57-9fcf-e063-6294a90aa916	2025-12-16		Exact identifier unii: 15FIX9V2JP
Virgo SOL Non Tinted Mousse	TITANIUM DIOXIDE, ZINC OXIDE	ULTRAVIOLET SKINCARE LLC	369d63a9-b9ab-9530-e063-6394a90ac8ef	2025-12-16		Exact identifier unii: 15FIX9V2JP
Kind Restore Moisturizing Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	POLISH BEAUTY	39814e27-4f3f-5ee6-e063-6394a90a941b	2025-12-16		Exact identifier unii: 15FIX9V2JP
Dr B Clinical Skin Care Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	NAIRA BABAIAN, M.D., P.A.	365da1f8-5250-7589-e063-6294a90a3e68	2025-12-16		Exact identifier unii: 15FIX9V2JP
Dr B Clinical Skin Care Non Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	NAIRA BABAIAN, M.D., P.A.	365d7564-3025-257b-e063-6294a90ad170	2025-12-16		Exact identifier unii: 15FIX9V2JP
Matte Defense Mineral Sunscreen non tinted	TITANIUM DIOXIDE, ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	3698090a-1639-00f9-e063-6394a90a7dd1	2025-12-16		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Primer SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	JOSEPHINA RAMIREZ	365cf2be-8862-3622-e063-6394a90ac4e3	2025-12-16		Exact identifier unii: 15FIX9V2JP
SANCTUARY Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CHAMPAGNE APOTHECARY LLC	365ca99c-c878-1f4b-e063-6394a90a1f53	2025-12-16		Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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