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 53 of 147 · 2,926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BHSkin Sheer Tinted Zinc and Titanium SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Don Mehrabi, M.D. A Professional Medical Corporation	44776529-3aa6-4fa3-b2ce-f624c4cf41bd	2025-12-15	Warnings	Exact identifier unii: 15FIX9V2JP
Tined Mineral Sunscreen Whipped Mousse	TITANIUM DIOXIDE, ZINC OXIDE	ESTILO SALON & SPA LLC	36999510-88f0-64fc-e063-6294a90a3d09	2025-12-15		Exact identifier unii: 15FIX9V2JP
Sunshade Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BELLAGENA SKINCARE STUDIO & SPA	37dec631-fdaf-fbdf-e063-6394a90a6c2b	2025-12-15		Exact identifier unii: 15FIX9V2JP
Matte Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	EDIT EUROSPA, LLC	37527317-0f10-d7e6-e063-6394a90a35a6	2025-12-15		Exact identifier unii: 15FIX9V2JP
Sunshade Mineral Stick Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BELLAGENA SKINCARE STUDIO & SPA	37ee31be-bfda-f052-e063-6294a90ac0bb	2025-12-15		Exact identifier unii: 15FIX9V2JP
Matte Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	EDIT EUROSPA, LLC	3751544d-e093-3d19-e063-6394a90aefc3	2025-12-15		Exact identifier unii: 15FIX9V2JP
Lip Crack	TITANIUM DIOXIDE, ZINC OXIDE	BELLAGENA SKINCARE STUDIO & SPA	37edc05c-82c3-90fe-e063-6294a90aa601	2025-12-15		Exact identifier unii: 15FIX9V2JP
Sunshade Daily Sun Defense	TITANIUM DIOXIDE, ZINC OXIDE	BELLAGENA SKINCARE STUDIO & SPA	37ee77dc-a96a-5efa-e063-6394a90affda	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	EDIT EUROSPA, LLC	37521c60-2fee-861e-e063-6294a90ad69a	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Tinted Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JADEIA LIMITED INC	35cf36c1-50c9-e848-e063-6294a90a6658	2025-12-15		Exact identifier unii: 15FIX9V2JP
Flash Invisible Stick	TITANIUM DIOXIDE, ZINC OXIDE	AEON AESTHETICS LLC	35d2489e-4978-4fc3-e063-6294a90adfcc	2025-12-15		Exact identifier unii: 15FIX9V2JP
Flash Tinted Stick	TITANIUM DIOXIDE, ZINC OXIDE	AEON AESTHETICS LLC	35d28590-e746-7996-e063-6294a90ac7d8	2025-12-15		Exact identifier unii: 15FIX9V2JP
Mineral Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JADEIA LIMITED INC	35cf03f4-200a-5643-e063-6394a90a9e02	2025-12-15		Exact identifier unii: 15FIX9V2JP
Daily Defense Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JADEIA LIMITED INC	35cf708c-244e-63a8-e063-6394a90a3b96	2025-12-15		Exact identifier unii: 15FIX9V2JP
Daily Defense Facial Sunscreen Plus Primer	TITANIUM DIOXIDE, ZINC OXIDE	LAURA CATHERINE, LLC	36e81e8e-0ba7-93e6-e063-6294a90a4e62	2025-12-15		Exact identifier unii: 15FIX9V2JP
Daily Defense Facial Sunscreen Plus Primer	TITANIUM DIOXIDE, ZINC OXIDE	LAURA CATHERINE, LLC	36e84147-5dcd-517a-e063-6394a90a54ee	2025-12-15		Exact identifier unii: 15FIX9V2JP
Artificial Tears	GLYCERIN	NuCare Pharmaceuticals,Inc.	97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d	2025-12-15	Warnings	Exact identifier unii: B697894SGQ
Tinted Mineral Sunscreen Plus Primer Matte	TITANIUM DIOXIDE, ZINC OXIDE	Simply Bare Waxing & Skin Care LLC	36d8e8ba-a3dd-257d-e063-6294a90a30d6	2025-12-15		Exact identifier unii: 15FIX9V2JP
Tinted Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LAURA CATHERINE, LLC	36e9e8d7-3fcf-1e94-e063-6394a90a8dc6	2025-12-15		Exact identifier unii: 15FIX9V2JP
Advanced Sun Protection	TITANIUM DIOXIDE, ZINC OXIDE	HELLO BEAUTIFUL SKIN STUDIO	36d45b48-e08d-ef40-e063-6394a90a635c	2025-12-15		Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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