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 37 of 147 · 2,926 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sei Bella Tinted BB Moisturizing Creme Deep 550 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e31a82-0cd0-5a1a-e053-2991aa0a33f8	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e2dfaa-d173-e6a9-e053-2a91aa0a4663	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium 300 W	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e2e541-c583-0f12-e053-2991aa0a4ab2	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 W	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e30231-4fba-35d4-e053-2991aa0a33cb	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium 440 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e30255-5640-3b4a-e053-2991aa0ab3f7	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 W	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e30255-564f-3b4a-e053-2991aa0ab3f7	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Medium 320 C	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e2e541-c596-0f12-e053-2991aa0a4ab2	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e20c57-7b30-4e96-e053-2991aa0aab3e	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	CONTROL CORRECTIVE SKINCARE INC	8ac09149-f7e7-40a8-b306-98964d0cd6e3	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Sensitive SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	32d78048-d281-1d80-e063-6394a90aec19	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
teeth and gums	CALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOS	Siddha Flower Essences LLC	926c79d5-d270-4c0d-aca9-b58571c24f3a	2025-12-31	Warnings	Exact identifier unii: 059QF0KO0R
lung and sinus	CALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOS	Siddha Flower Essences LLC	9f7c949f-21bc-473c-ab8d-24837893fccc	2025-12-31	Warnings	Exact identifier unii: 059QF0KO0R
Value Health by Prodose Eye Drops	TETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400	Prodose, Inc.	3fafa362-a8a6-3f91-e063-6394a90a98b3	2025-12-31	Warnings	Exact identifier unii: B697894SGQ
Dr.Jart Cicapair Tiger Grass Color Correcting Treatment	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	40f96baf-0359-4d68-801f-68562c909446	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Fair-Light	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	b38b1b64-b433-4e11-9cf6-2108a552d139	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Light Medium-Medium	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	45b1c2c6-a45b-4a45-bec9-e5341079c0a1	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Medium-Tan	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	28a2ba45-1eff-488c-aae4-362b9f78b8df	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Deep Tan-Deep	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	3c346960-b76b-4241-a188-8ee694853078	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
DR.JART CICAPAIR TIGER GRASS CAMO DROPS	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	f06348f5-4ebc-325b-e053-2a95a90ada52	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP
DR.JART EVERY SUN DAY MINERAL SUN SCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Have & Be Co., Ltd.	f06c31b4-da5f-6495-e053-2995a90ae67c	2025-12-31	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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