FDA.reportPublic FDA data

NDC 0062-5434 - MONISTAT-DERM

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
0062-5434
Package NDCs from labels
0062-5434-02, 0062-5434-01, 0062-5434-03
Manufacturer
Ortho Dermatological
Effective date
2007-04-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MONISTAT-DERM - Ortho DermatologicalOrtho Dermatological2007-04-17HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0062-5434-01MONISTAT-DERM28 g in 1 TUBECREAM282
0062-5434-02MONISTAT-DERM15 g in 1 TUBECREAM152
0062-5434-03MONISTAT-DERM85 g in 1 TUBECREAM852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0062-5434MONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]23 package rows20070531_cb161d23-bc41-4cec-9e42-dfeef861d161.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole nitrateACTIVE INGREDIENTVW4H1CYW1KMONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]2
Miconazole nitrateACTIVE MOIETYVW4H1CYW1KMONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]2
Benzioc acidINACTIVE INGREDIENTMONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]2
Butylated hydroxyanisoleINACTIVE INGREDIENTMONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]2
Mineral oilINACTIVE INGREDIENTMONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]2
Peglicol 5 oleateINACTIVE INGREDIENTMONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]2
Pegoxol 7 stearateINACTIVE INGREDIENTMONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]2
WaterINACTIVE INGREDIENT059QF0KO0RMONISTAT-DERM (MICONAZOLE NITRATE) CREAM [ORTHO DERMATOLOGICAL]2

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 5 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutionsbf131f33-3ab2-4f43-add5-920e78ac36a72025-02-24WarningsExact identifier
rxcui: 998483
MICONAZOLE NitrateMICONAZOLE NITRATENuCare Pharmaceuticals,Inc.fd7dd2eb-03a7-ef1f-e053-6294a90a85572025-02-04WarningsExact identifier
rxcui: 998483
miconazole 1MICONAZOLE NITRATEMeijer Distribution Incc34d9917-ee79-4afb-9338-6f18e63b2b092025-01-13WarningsExact identifier
rxcui: 998483
MICONAZOLE Nitrate 2%MICONAZOLE NITRATEAkron Pharma Inc.8933f939-098a-4257-8d9c-4d5c3240e9a62025-01-10WarningsExact identifier
rxcui: 998483
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kitMICONAZOLE NITRATECosette Pharmaceuticals, Inc.eed88487-a7ba-4853-8519-13f92ed5539f2025-01-06WarningsExact identifier
rxcui: 998483
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATERugbyf420de00-408f-9a2c-e053-2995a90adced2024-12-17WarningsExact identifier
rxcui: 998483
up and up miconazoleMICONAZOLE NITRATETarget Corporationb626313a-b8aa-43fe-b8a9-475009ea5b532024-12-11WarningsExact identifier
rxcui: 998483
miconazole 1 yeast infection reliefMICONAZOLE NITRATECVS Pharmacyb0e5320b-73d5-4e96-8ce4-9a858e9d2ed32024-12-10WarningsExact identifier
rxcui: 998483
BOA VIDA AntifungalMICONAZOLE NITRATECentral Solutions Inc69c5340d-9abd-43bf-a90b-9568d615f06f2024-12-09WarningsExact identifier
rxcui: 998483
Miconazole NitrateANTIFUNGALMcKesson8dcca44a-16c7-7262-e053-2a95a90a1b232024-10-10WarningsExact identifier
rxcui: 998483
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEASTONEA LABS PRIVATE LIMITEDe66191a6-0c3c-7319-e053-2a95a90aae842024-06-25WarningsExact identifier
rxcui: 998483
Antifungal BodyMICONAZOLE NITRATEMcKesson4fb9aece-0baa-475e-e054-00144ff8d46c2024-06-13WarningsExact identifier
rxcui: 998483
Anti-FungalMICONAZOLE NITRATEUniversal Distribution Center LLC8f316b0d-d308-4ae6-82c4-39bb0d1d474e2024-05-21WarningsExact identifier
rxcui: 998483
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7a0ef38a-9584-4e67-ba86-c31f86da1ed02023-12-11WarningsExact identifier
rxcui: 998483
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7d284f6f-a970-49fe-b45a-d5c6c2688bc22023-12-11WarningsExact identifier
rxcui: 998483
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb564f971-2a9b-a605-e053-2995a90aee692023-11-17WarningsExact identifier
rxcui: 998483
MacerRx WebMICONAZOLE NITRATEClinical Therapeutic Solutionsc9327f41-10f1-41f3-855b-838c701d67672023-11-05WarningsExact identifier
rxcui: 998483
careone miconazole 1MICONAZOLE NITRATEAmerican Sales Companyf51af8e2-fb06-4842-8021-b7efd515022e2023-10-23WarningsExact identifier
rxcui: 998483
miconazole 1MICONAZOLE NITRATEH E B40cc911b-2c35-4382-a979-fb1a165049db2022-11-12WarningsExact identifier
rxcui: 998483
Good Neighbor Pharmacy Miconazole 1MICONAZOLE NITRATEAmerisource Bergen12c400dc-4fbf-4a10-9a4d-5156d65b509a2022-11-09WarningsExact identifier
rxcui: 998483

Reported adverse events (FAERS/openFDA)#

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