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 9 of 149 · 2,969 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEMORRHOIDAL	MINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY, INC	93482a9b-145b-42d4-96db-599c281a39f1	2026-06-10	Warnings	Exact identifier unii: 4T6H12BN9U
SUPRADERM	WHITE PETROLATUM, LANOLIN	Olen Skin Care Corporation	4e7199bd-52c6-48e9-9c78-c84e45412faf	2026-06-10	Warnings	Exact identifier unii: 4T6H12BN9U
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	53d76b02-442e-7a5d-e063-6394a90ae1b3	2026-06-09	Warnings	Exact identifier unii: 15FIX9V2JP
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	53d9d689-4a86-5b9c-e063-6394a90aef18	2026-06-09	Warnings	Exact identifier unii: 15FIX9V2JP
XIMONTH Fungi Free Bee Venom Nail Soothing Serum	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	53bab969-8407-6334-e063-6294a90aa5d1	2026-06-08	Warnings	Exact identifier unii: 059QF0KO0R
Eryfotona Ageless Tinted Lightweight Emulsion Sunscreen	TITANIUM DIOXIDE	ISDIN Corp.	293a1116-e8a2-495f-83db-20dd82ed13c2	2026-06-08	Warnings	Exact identifier unii: 15FIX9V2JP
Eryfotona Actinica Tinted	TITANIUM DIOXIDE	ISDIN Corp.	97357703-0e93-4216-bd1b-a9b202781959	2026-06-05	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Untinted	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop, LLC	08671d39-3be2-d666-e063-6294a90a6207	2026-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Mattescreen SPF 40 - Golden Hour	TITANIUM DIOXIDE, ZINC OXIDE	Supergoop, LLC	c2398820-f003-707f-e053-2a95a90a6929	2026-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
Epionce Daily Shield Tinted SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Episciences, Inc.	3d1e2921-cba9-4446-e054-00144ff8d46c	2026-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
VitaPhyte Redness Reliever Lubricant Eye Drops	REDNESS RELIEVER LUBRICANT EYE DROPS	Guangzhou Liyan Cosmetics Technology Co., Ltd.	53d4e9b0-c9a0-797a-e063-6294a90ad0cf	2026-06-04	Warnings	Exact identifier unii: B697894SGQ
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GB	ZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDE	HONGKONG JIAHE INTERNATIONAL HOLDING LIMITED	5354af18-50c4-5fba-e063-6394a90ace39	2026-06-03	Warnings	Exact identifier unii: 15FIX9V2JP
Hemorrhoidal	GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM	HyVee Inc	b867f691-7a13-4659-b664-06aa36899310	2026-06-03	Warnings	Exact identifier unii: 4T6H12BN9U
ATOMY BB SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	b0cd27ee-4917-4800-bcdf-c6e14b28c1d1	2026-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	ad0b9091-a990-45bf-93f4-d886be1bbffe	2026-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUS	HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	ATOMY CO., LTD.	994d5680-284e-4faf-a29b-4d28f8d46e8f	2026-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40	ZINC OXIDE, TITANIUM DIOXIDE	Private Label Skin Care	a8d60212-18a7-42af-8bb3-bfcff7690a49	2026-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
The Mineral Melt SPF30	ZINC OXIDE, TITANIUM DIOXIDE	Dune Suncare Inc.	2114fc3b-c8ce-45d2-8a82-4dc54f0adaf3	2026-06-02	Warnings	Exact identifier unii: 15FIX9V2JP
ADVANCED HEALING	PETROLATUM	Rejoice International Corp.	532c7e5a-4d05-3bd0-e063-6294a90aee00	2026-06-01	Warnings	Exact identifier unii: 4T6H12BN9U
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	a1acb789-5bf4-4447-b3c5-4a7d4d3013a7	2026-06-01	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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