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 58 of 147 · 2,926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Saving Face Skinspa Inc.	351db99e-262f-b67e-e063-6394a90a3418	2025-12-11	Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	DAISY'S SKIN TRANSFORMATION LLC	37d9fbf5-d602-d3dc-e063-6394a90abe53	2025-12-11	Exact identifier unii: 15FIX9V2JP
Tinted Mineral 40	TITANIUM DIOXIDE, ZINC OXIDE	2301 PLASTIC SURGERY, PLLC	374d53a7-be0b-4d7a-e063-6394a90a37c4	2025-12-11	Exact identifier unii: 15FIX9V2JP
Tinted Mineral 40	TITANIUM DIOXIDE, ZINC OXIDE	2301 PLASTIC SURGERY, PLLC	374df66d-eb9b-c4a7-e063-6394a90a3cc6	2025-12-11	Exact identifier unii: 15FIX9V2JP
Facial Mineral Sunscreen Mineral Protection	TITANIUM DIOXIDE, ZINC OXIDE	CAPE COD SKIN CARE CO. INC.	387f6dd5-3901-0849-e063-6294a90af8bc	2025-12-11	Exact identifier unii: 15FIX9V2JP
Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LEDUC, XUANTO MD	387e2e59-c5db-c70e-e063-6394a90a2d26	2025-12-11	Exact identifier unii: 15FIX9V2JP
Facial Mineral Sunscreen Mineral Protection	TITANIUM DIOXIDE, ZINC OXIDE	CAPE COD SKIN CARE CO. INC.	390779a8-4556-27a5-e063-6294a90a1200	2025-12-11	Exact identifier unii: 15FIX9V2JP
non-tinted sheer matte mineral	TITANIUM DIOXIDE, ZINC OXIDE	NEXTEX CORPORATION	35ba6cc9-0d49-6d0c-e063-6394a90ac7c3	2025-12-11	Exact identifier unii: 15FIX9V2JP
sheer tinted matte mineral	TITANIUM DIOXIDE, ZINC OXIDE	NEXTEX CORPORATION	35ba9ca7-fe5c-9824-e063-6394a90a5c46	2025-12-11	Exact identifier unii: 15FIX9V2JP
illuminating mineral mousse	TITANIUM DIOXIDE, ZINC OXIDE	NEXTEX CORPORATION	35bb4d67-373f-f60c-e063-6394a90a974d	2025-12-11	Exact identifier unii: 15FIX9V2JP
Soft Focus Mineral Defense Tinted	TITANIUM DIOXIDE, ZINC OXIDE	SPOTLESS SKIN STUDIO	387f1ea9-4764-3abe-e063-6394a90adde0	2025-12-11	Exact identifier unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen Primer	TITANIUM DIOXIDE, ZINC OXIDE	Mint Skin Incorporated	352efbee-cab4-c515-e063-6294a90a46f2	2025-12-11	Exact identifier unii: 15FIX9V2JP
Daily Defense Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LEDUC, XUANTO MD	387e6e79-94db-dbb1-e063-6394a90aefd6	2025-12-11	Exact identifier unii: 15FIX9V2JP
Matte Defense Sunscreen Primer	TITANIUM DIOXIDE, ZINC OXIDE	Mint Skin Incorporated	352f5c53-3075-f437-e063-6394a90a4c4e	2025-12-11	Exact identifier unii: 15FIX9V2JP
Prevention	TITANIUM DIOXIDE, ZINC OXIDE	Noble Center for Healthy Aging LLC	387dbf46-4316-a15d-e063-6394a90adeb1	2025-12-11	Exact identifier unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen Primer	TITANIUM DIOXIDE, ZINC OXIDE	Mint Skin Incorporated	352f8de3-8ff0-4098-e063-6294a90ace4d	2025-12-11	Exact identifier unii: 15FIX9V2JP
Tinted Matte Defense Sunscreen Primer	TITANIUM DIOXIDE, ZINC OXIDE	Mint Skin Incroporated	35305bf1-8947-f275-e063-6294a90a3024	2025-12-11	Exact identifier unii: 15FIX9V2JP
ProtectME Tinted Mineral SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	PUREFECTION LA, INC.	33dccd5d-8db1-f699-e063-6394a90a59a2	2025-12-10	Exact identifier unii: 15FIX9V2JP
Tinted Mineral Moisturizing Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ABOUT FACE AESTHETICS, INC.	364728b4-e0ff-8466-e063-6394a90a0089	2025-12-10	Exact identifier unii: 15FIX9V2JP
tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Skin & Bare It LLC	35d42661-e511-1dfc-e063-6294a90a9ed7	2025-12-10	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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