FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Nystatin Cream USP, 100,000 units per gramSun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. | Taro Pharmaceutical Industries Ltd.2025-07-03HUMAN PRESCRIPTION DRUG LABEL
Nystatin Cream USP, 100,000 units per gramNuCare Pharmaceuticals,Inc.2025-02-10HUMAN PRESCRIPTION DRUG LABEL
NYSTATIN - DIRECT RXDIRECT RX2025-01-20HUMAN PRESCRIPTION DRUG LABEL
Nystatin Cream USP, 100,000 units per gramNuCare Pharmaceuticals,Inc.2024-08-14HUMAN PRESCRIPTION DRUG LABEL
Nystatin Cream USP, 100,000 units per gramPreferred Pharmaceuticals Inc. | Preferred PharmaceuticalsInc.2024-07-23HUMAN PRESCRIPTION DRUG LABEL
Nystatin - Proficient Rx LPProficient Rx LP2019-11-01HUMAN PRESCRIPTION DRUG LABEL
Nystatin Cream USP, 100,000 units per gramPreferred Pharmaceuticals Inc.2019-01-30HUMAN PRESCRIPTION DRUG LABEL
NYSTATIN - Physicians Total Care, Inc.Physicians Total Care, Inc.2011-05-10HUMAN PRESCRIPTION DRUG LABEL
Nystatin - Rebel Distributors CorpRebel Distributors Corp2010-10-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1289-1Nystatin15 g in 1 TUBECREAM156
51672-1289-1Nystatin1 in 1 CARTONCREAM16
51672-1289-2Nystatin1 in 1 CARTONCREAM16
51672-1289-2Nystatin30 g in 1 TUBECREAM306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1289NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 4 package rows20230126_4d845b3f-ca26-4c47-b424-b6d783cc10e5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1289-1GM - Gram51672-128938067616-cd05-468d-a844-b2ec0513e43f12012-07-24
51672-1289-2GM - Gram51672-12894f7b2183-b586-49ab-9a71-4e40d5479cb912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
algeldrateINACTIVE INGREDIENT03J11K103CNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
ceteareth-15INACTIVE INGREDIENT867H4YOZ8ZNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium hydroxideINACTIVE INGREDIENT55X04QC32INYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
sorbitolINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
NYSTATINACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
NystatinACTIVE INGREDIENTBDF1O1C72ENYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
NYSTATINACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
NystatinACTIVE MOIETYBDF1O1C72ENYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
ALGELDRATEINACTIVE INGREDIENT03J11K103CNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
ALGELDRATEINACTIVE INGREDIENT03J11K103CNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
CETEARETH-12INACTIVE INGREDIENT7V4MR24V5PNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
CETEARETH-15INACTIVE INGREDIENT867H4YOZ8ZNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32INYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
SORBITOLINACTIVE INGREDIENT506T60A25RNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNYSTATIN CREAM [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RNYSTATIN 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 49 of 147 · 2,926 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543a22c-34d5-e572-e063-6394a90ad5792025-12-15Exact identifier
unii: 15FIX9V2JP
Stellar Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb6488c-d216-8742-e063-6394a90a16e22025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb8ee19-81b2-daed-e063-6394a90a0fb32025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb6cfd4-fa4a-d1d9-e063-6394a90a8e432025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC35442ac0-c361-e08f-e063-6294a90a5cb22025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543e85d-9bc7-b8ed-e063-6294a90ae7d32025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bc8593d-fc6c-04aa-e063-6394a90a6d562025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMantra Wellness Spa3389b0a3-40f9-b411-e063-6394a90a99592025-12-15Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39959db9-5ee1-a27c-e063-6394a90a1e102025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995f556-20fe-3e64-e063-6294a90a5efe2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995385b-b10b-ca5c-e063-6294a90af43f2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3994aa84-30b4-3dc4-e063-6394a90a23e72025-12-15Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39947913-f1cc-25d2-e063-6294a90a42292025-12-15Exact identifier
unii: 15FIX9V2JP
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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