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 4 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
miconazole 3MICONAZOLE NITRATEH E Bf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa62025-10-31WarningsExact identifier
rxcui: 998483
miconazole 3 dayMICONAZOLE NITRATEPublix Super Markets Inc9ff23f06-e97f-46ad-8601-97ca05c260a02025-09-16WarningsExact identifier
rxcui: 998483
Antifungal CreamMICONAZOLE NITRATEEncube Ethicals, Inc.8be4bbfa-424c-4ccf-b8bc-65b16c1260532025-09-04WarningsExact identifier
rxcui: 998483
Nedtol Folliculitis Treatment CreamsMICONAZOLE NITRATEJiashen International Trade Limited3d0a1e39-82e4-9337-e063-6294a90aa9a32025-08-23WarningsExact identifier
rxcui: 998483
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.cca84334-2e2d-4991-9d1e-d5b7c9ffd3922025-08-01WarningsExact identifier
rxcui: 998483
SUNMARK MICONAZOLE NITRATE antifungalMICONAZOLE NITRATEStrategic Sourcing Services LLC7c15d95a-5b89-4789-8c91-3f61d7ec77072025-07-30WarningsExact identifier
rxcui: 998483
FifthPulse Miconazole Nitrate Cream 1ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a37a3a8-9d05-926c-e063-6294a90a9ed82025-07-18WarningsExact identifier
rxcui: 998483
FifthPulse Miconazole Nitrate Cream 4ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a382b79-dde9-dde0-e063-6294a90a53bb2025-07-18WarningsExact identifier
rxcui: 998483
Miconazole NitrateMICONAZOLE NITRATESTRATEGIC SOURCING SERVICES LLC966a1000-3b08-4f2c-a9f8-568f2524b7172025-07-15WarningsExact identifier
rxcui: 998483
ConazolMICONAZOLE NITRATELaboratorios Liomont, S.A. de C.V.84780538-8618-5750-e053-2a91aa0a60542025-07-07WarningsExact identifier
rxcui: 998483
MiconazoleMICONAZOLE NITRATEChain Drug Consortium, LLC246be926-79ea-4e0c-a3ef-2aa7fc3a52bf2025-06-30WarningsExact identifier
rxcui: 998483
Good Neighbor Pharmacy Miconazole 3MICONAZOLE NITRATEAmerisource Bergen5b87b837-3f52-40ca-b2b6-9c1f1262d90d2025-06-23WarningsExact identifier
rxcui: 998483
Fungazol Athlete FootMICONAZOLE NITRATERida LLCce60e1ec-a69b-4b98-a2b2-105e9cd37bc72025-05-28WarningsExact identifier
rxcui: 998483
Good Sense Miconazole 3MICONAZOLE NITRATEL. Perrigo Company9aeac709-001b-4617-8046-186264847ec82025-05-15WarningsExact identifier
rxcui: 998483
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATECardinal Health 110 dba LEADER34f4c733-2eb2-0db0-e063-6394a90a64312025-05-13WarningsExact identifier
rxcui: 998483
Miconazole 3MICONAZOLE NITRATECVS Pharmacy9f506f59-e435-465d-90c7-9b0edc44160d2025-04-24WarningsExact identifier
rxcui: 998483
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEGERI-GENTLE CORPORATIONe6734616-c16b-430c-e053-2a95a90a18f82025-04-21WarningsExact identifier
rxcui: 998483
Tagrid Jock Itch Miconazole Nitrate 2%MICONAZOLE NITRATETAGRID LLC31abdc68-5027-15e7-e063-6394a90ac4e62025-03-31WarningsExact identifier
rxcui: 998483
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.14d2a661-a490-41ca-b84f-f2be3bc271b42025-03-24WarningsExact identifier
rxcui: 998483
Athletes FootMICONAZOLE NITRATERida LLC85e98ef8-75c3-4be1-b59f-40b5312e21372025-03-06WarningsExact identifier
rxcui: 998483

Reported adverse events (FAERS/openFDA)#

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