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 41 of 147 · 2,939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	897b8edb-f089-4a49-baca-e05806b0a068	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP
OI LIN SUNMILK SUNSCREEN SPF 30	SUNSCREEN, TITANIUM DIOXIDE	Sunrider Manufacturing L.P.	26b57314-1616-4ca4-b65f-a363c525b432	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP
OCUFRESH	WATER	Optics Laboratory Inc.	b8e477a9-66b9-496b-92fb-3d4bbd7b36b5	2025-12-29	Warnings	Exact identifier unii: 059QF0KO0R
WinCo FoodsPetroleum Jelly	WHITE PETROLATUM	WinCo Foods, LLC	f5dcf0b2-4f9f-023a-e053-2995a90a183a	2025-12-28	Warnings	Exact identifier unii: 4T6H12BN9U
WinCo FoodsPetroleum Jelly	WHITE PETROLATUM	WinCo Foods, LLC	f5dca60a-e9bc-4161-e053-2995a90a2bcb	2025-12-28	Warnings	Exact identifier unii: 4T6H12BN9U
Kollourion Eyesalve Eyewash	PURIFIED WATER 98.3%	Miracle Eye Pharmaceuticals	b56d2ab9-169b-b490-e053-2a95a90a80b3	2025-12-28	Warnings	Exact identifier unii: 059QF0KO0R
Hydrating Healing	HYDRATING HEALING OINTMENT	Neilmed Pharmaceuticals Inc.,	47106abb-4c39-07d9-e063-6394a90a4fae	2025-12-28	Warnings	Exact identifier unii: 4T6H12BN9U
TINTED FACIAL SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	1259035e-9196-97de-e063-6394a90a9dec	2025-12-22	Warnings	Exact identifier unii: 15FIX9V2JP
SPF 50 MINERAL SUNSCREEN LIP	ZINC OXIDE , TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	1c6f0964-9bee-1c06-e063-6294a90ac2a4	2025-12-22	Warnings	Exact identifier unii: 15FIX9V2JP
G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	LABORATOIRES DERMO-COSMETIK INC.	468c90d7-3b9e-1641-e063-6394a90a928c	2025-12-22	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO3	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	468d6476-127a-e9f0-e063-6294a90a3df9	2025-12-22	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR SKIN BUT BETTER FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	3e65ec1a-0ed9-433d-8da9-a6cb61829911	2025-12-22	Warnings	Exact identifier unii: 15FIX9V2JP
Good Neighbor Petroleum Jelly	WHITE PETROLATUM	AmerisourceBergen	e5fb80a0-cc8c-e9e7-e053-2a95a90a455d	2025-12-22	Warnings	Exact identifier unii: 4T6H12BN9U
THE MELT MIST Sheerest Mineral Mist Suncare for Body	TITANIUM DIOXIDE, ZINC OXIDE	Dune Suncare, Inc.	465d3277-7798-512a-e063-6294a90a2065	2025-12-20	Warnings	Exact identifier unii: 15FIX9V2JP
HEMORRHOIDAL	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	Safeway	3e6728b6-26e3-4287-8ba6-e27f305cd93b	2025-12-20	Warnings	Exact identifier unii: 4T6H12BN9U
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 9N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7287078e-67ff-41fe-bc8d-59b2146f5dc9	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WO	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b6095639-e2ee-418e-b4f1-e59da1bd9216	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8c6466a6-4f11-4210-bb02-eb31c15984cd	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	07f8282b-047b-4be1-8779-39ed5dd6fb5d	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5a8c67c1-aeba-490d-8347-a30916efcf3b	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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