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 24 of 147 · 2,939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Comforts Petroleum Jelly	WHITE PETROLATUM	KROGER	3feb3638-1cdc-62d4-e063-6294a90a1d89	2026-02-03	Warnings	Exact identifier unii: 4T6H12BN9U
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREEN	HOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDE	Oracle Cosmetic Co., Ltd.	21424f78-f8d5-6a9b-e063-6294a90ab7dc	2026-02-02	Warnings	Exact identifier unii: 15FIX9V2JP
Vitamin A D	LANOLIN, PETROLATUM	Kroger Co.	b4aa9b58-d95e-4dac-9a34-213482e8ca34	2026-02-02	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Optase	WHITE PETROLATUM, LANOLIN	Scope Health Inc	c1991caa-51b9-13d1-e053-2995a90a1293	2026-01-31	Warnings	Exact identifier unii: 4T6H12BN9U
Lanolin, Petrolatum	LANOLIN, PETROLATUM	Rite Aid Corporation	1b6d7cdf-e7bc-4fd4-939c-5eb0eaa1744d	2026-01-30	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Pure petroleum	WHITE PETROLATUM	Rite Aid Corporation	f67be4cc-9983-4758-93c8-383919ec07ca	2026-01-30	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Advanced Healing	PETROLATUM	Rite Aid Corporation	0d535736-ba61-42eb-9112-c154295372a2	2026-01-30	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
Reef safe unscented SPF 50 mineral sunscreen 01	TITANIUM DIOXIDE, ZINC OXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	49a77ad4-508c-9617-e063-6394a90a5623	2026-01-30	Warnings	Exact identifier unii: 15FIX9V2JP
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetic Solutions LLC	d65ae1c9-dff5-4612-b8be-fa59bba03b81	2026-01-30	Warnings	Exact identifier unii: 15FIX9V2JP
UNIVERSAL BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	ec67a1ee-ad71-54f2-e053-2995a90a7690	2026-01-29	Warnings	Exact identifier unii: 4T6H12BN9U
Petroleum	WHITE PETROLATUM	7-Select	7e93df71-74bd-4d95-9a64-54756c7b234a	2026-01-29	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
TheraCare Diabetic Foot Cream	DIMETHICONE, PETROLATUM	Veridian Healthcare	49132a75-4a16-cede-e063-6294a90a6217	2026-01-29	Warnings	Exact identifier unii: 4T6H12BN9U
TheraCare A and D	LANOLIN, PETROLATUM	Veridian Healthcare	1303aa33-2111-b36c-e063-6294a90af131	2026-01-29	Warnings	Exact identifier unii: 4T6H12BN9U
Advanced Healing	PETROLATUM	Aldi, Inc	94fea2f2-fea8-4923-afc6-36068bc2fef5	2026-01-29	Warnings, Adverse reactions	Exact identifier unii: 4T6H12BN9U
UNIVERSAL LAVENDER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	066b1313-aed8-9436-e063-6294a90a2b11	2026-01-29	Warnings	Exact identifier unii: 4T6H12BN9U
careone hemorrhoidal	MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL	American Sales Company	46794d2e-8fe6-490d-9cfa-ba9b6c209ad6	2026-01-29	Warnings	Exact identifier unii: 4T6H12BN9U
SHISEIDO SPORTS BB DARK	OCTINOXATE AND TITANIUM DIOXIDE	SHISEIDO AMERICAS CORPORATION	f4fc4b6a-9507-496e-9ecb-8400055ecf2d	2026-01-28	Warnings	Exact identifier unii: 15FIX9V2JP
Hampton Sun SPF 30 Mineral	ZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%	S&C Hampton Sun LLC	b8ee428e-07d3-4c6c-853c-cfbe3e4002d9	2026-01-28	Warnings	Exact identifier unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Amalfi	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFI	LE COSMETICS INC	4963658b-59bb-b313-e063-6394a90a0a51	2026-01-27	Warnings	Exact identifier unii: 15FIX9V2JP
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen Rio	CEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIO	LE COSMETICS INC	49644002-153f-c254-e063-6394a90a46eb	2026-01-27	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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