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 23 of 147 · 2,939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hampton Sun SPF 50 Mineral	ZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%	S&C Hampton Sun LLC	d6c33436-042e-44e8-8b55-98be6e246879	2026-02-06	Warnings	Exact identifier unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZER	OCTINOXATE, TITANIUM DIOXIDE	Shiseido Americas Corporation	f291f077-1c72-48fc-bb19-c20bdeaaa596	2026-02-06	Warnings	Exact identifier unii: 15FIX9V2JP
Petrolatum	WHITE PETROLATUM	Retail Business Services, LLC	bf0c9494-0138-4346-9348-e235ca4d9e58	2026-02-06	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Advanced Healing	PETROLATUM	Retail Business Services, LLC	6e9121c8-5eb9-4d0b-86c5-b892e14bdab8	2026-02-06	Warnings	Exact identifier unii: 4T6H12BN9U
Petrolatum	WHITE PETROLATUM	Retail Business Services, LLC	bf73c618-ed2f-4468-a51f-ff61c7b1f506	2026-02-06	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
SHISEIDO WASO COLOR-SMART DAY MOISTURIZER	OCTINOXATE, TITANIUM DIOXIDE	Shiseido Americas Corporation	54f63dd8-e77f-42e4-a6d3-61ab7beecf50	2026-02-06	Warnings	Exact identifier unii: 15FIX9V2JP
Petroleum	WHITE PETROLATUM	Salado Sales Inc.	f973e3a5-3b45-4842-99ce-dff676ae1f96	2026-02-06	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Nystatin Oral Suspension	NYSTATIN	Xttrium Laboratories, Inc.	4a670371-d373-1ba6-e063-6394a90a13b6	2026-02-06	Adverse reactions	Exact identifier unii: BDF1O1C72E
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Sportpharm LLC	8d58dcbb-72a0-41f0-9eeb-613072a6d7ae	2026-02-06	Warnings	Exact identifier unii: B697894SGQ
SEYTU Body Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Omnilife USA, Inc.	c411e9a6-b2ea-446b-a886-b92c61736e6c	2026-02-05	Warnings	Exact identifier unii: 15FIX9V2JP
SEYTU Facial Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Omnilife USA, Inc.	96fd37fb-c3ff-413f-b2c8-50754f320ecc	2026-02-05	Warnings	Exact identifier unii: 15FIX9V2JP
Petroleum Skin Protectant	WHITE PETROLATUM	Pharmacy Value Alliance, LLC	0ce03cd1-c48d-45cf-b11f-08bade55dcb6	2026-02-05	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Signature Care Hemorrhoidal	MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCI	Better Living Brands, LLC	3c8b43f3-6e1e-499e-ba71-ffdf836f6743	2026-02-05	Warnings	Exact identifier unii: 4T6H12BN9U
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Bamboo	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	ebfe03e7-614f-44b1-b1f1-78edc7e274cc	2026-02-05	Warnings	Exact identifier unii: 15FIX9V2JP
0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	1cada0ae-3f0f-441c-a633-faa0a3009d2b	2026-02-05	Warnings	Exact identifier unii: 4T6H12BN9U
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42	TITANIUM DIOXIDE AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	86630e82-f249-4866-82dd-3e21feb266c4	2026-02-04	Warnings	Exact identifier unii: 15FIX9V2JP
Petroleum	WHITE PETROLATUM	Harris Teeter	de380df6-cc6e-4b2a-98de-fc08eeb6e8ea	2026-02-04	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Petroleum	WHITE PETROLATUM	Hy-Vee, Inc.	45867f42-9562-c111-e063-6394a90adb70	2026-02-04	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Petroleum Skin Protectant	WHITE PETROLATUM	Major Pharmaceuticals	0e7e11c5-a1f8-43c4-b8a6-211491052404	2026-02-04	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	Sportpharm LLC	88e3624d-b8bb-4e65-9250-4c51d2bbed16	2026-02-03	Warnings	Exact identifier unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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