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 20 of 147 · 2,939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vitamin A D	LANOLIN, PETROLATUM	Walmart Inc.	5893801a-25e1-4750-a55b-d9cddd3f1284	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Skin Protectant	PETROLATUM	Walmart Inc.	eb836922-f467-42ab-a6e7-b787d97e6c17	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Advanced Healing	PETROLATUM	Walmart Inc.	aa7dbf7f-50be-475b-8140-68be3fa93507	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
White Petrolatum	WHITE PETROLATUM	Walmart Inc.	176d7711-7c4f-4319-91af-0aba1260c412	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
TIBENA EVERY DAY REAL SUN BLOCK	TITANIUM DIOXIDE, ZINC OXIDE	KONAD CO LTD	211c9930-4f91-cf8f-e063-6394a90a97b3	2026-02-26	Warnings	Exact identifier unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10	TITANIUM DIOXIDE	Shiseido Americas Corporation	54f8210f-4934-4ada-89c3-aa89e7a09260	2026-02-26	Warnings	Exact identifier unii: 15FIX9V2JP
Panama Jack SPF 45 Flavorless Lip Balm	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUM	Panama Jack	1b15c00b-0e78-4dbe-877c-de3941ffe76e	2026-02-26	Warnings	Exact identifier unii: 4T6H12BN9U
Dermatool Hemorrhoidal	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	Papalo Group LLC	4bc06f41-7733-ebd0-e063-6294a90af7a8	2026-02-26	Warnings	Exact identifier unii: 4T6H12BN9U
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY	OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	c05cef12-a6a7-4682-9357-6d77f4ca3267	2026-02-25	Warnings	Exact identifier unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FOUNDATION N M I10	OCTINOXATE AND TITANIUM DIOXIDE	Shiseido Americas Corporation	3be1fe06-bd3b-4078-bee9-d3caf8d068ff	2026-02-25	Warnings	Exact identifier unii: 15FIX9V2JP
Jack Black	AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM	Jack Black L.L.C.	4babe2ab-c5da-9a83-e063-6294a90aee4c	2026-02-25	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black	AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM	Jack Black L.L.C.	4bac1c33-36fe-8d29-e063-6394a90a32a5	2026-02-25	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black	AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM	Jack Black L.L.C.	4bac5550-c45f-a738-e063-6394a90ae5c8	2026-02-25	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black	AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM	Jack Black L.L.C.	4baca374-7aaa-8d1d-e063-6394a90a5a55	2026-02-25	Warnings	Exact identifier unii: 4T6H12BN9U
Jack Black	AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM	Jack Black L.L.C.	4bad1502-bc44-54ec-e063-6294a90ace8b	2026-02-25	Warnings	Exact identifier unii: 4T6H12BN9U
Petroleum Skin Protectant	WHITE PETROLATUM	Family Dollar Stores, Inc	ac7da793-8a39-4b47-b075-a4c4820cadad	2026-02-24	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
cle de peau BEAUTE THE FOUNDATION N M O20	OCTINOXATE AND TITANIUM DIOXIDE	Shiseido Americas Corporation	9507f6d1-c11c-428d-8d95-b436f27ba26a	2026-02-24	Warnings	Exact identifier unii: 15FIX9V2JP
Advanced Healing	PETROLATUM	Family Dollar Stores, Inc	7e64a424-afdb-4eb9-b6af-7b8123f1e207	2026-02-24	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Perfect Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SKIN PERFECT MEDICAL	4b93538a-3b3e-90f7-e063-6294a90ab898	2026-02-24	Warnings	Exact identifier unii: 15FIX9V2JP
Petroleum Skin Protectant	WHITE PETROLATUM	H E B	e6154e44-d7b2-429c-9bc7-5c064220d3fb	2026-02-24	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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