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 3 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Secura Antifungal GreaselessMICONAZOLE NITRATESmith & Nephew Medical Ltd9be600e4-76ec-4071-a8ec-a0b23155271d2026-04-02WarningsExact identifier
rxcui: 998483
RoyceDerm Anti-Fungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC4e861073-88e8-b2f7-e063-6394a90ab94a2026-04-02WarningsExact identifier
rxcui: 998483
Baza AntifungalMICONAZOLE NITRATEColoplast Corp75182cb7-840a-423a-9c20-10840d6e1d652026-03-31WarningsExact identifier
rxcui: 998483
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATETrifecta Pharmaceuticals Usa Llc80217dbb-a0f0-414a-8d22-a9a346b017aa2026-03-31WarningsExact identifier
rxcui: 998483
Doctor Jiao Antifungal CreamMICONAZOLE NITRATEJiangxi Haiwei Pharmaceutical Co., Ltd.4e3b231e-0642-bf63-e063-6394a90a905b2026-03-30WarningsExact identifier
rxcui: 998483
Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock ItchANTIFUNGAL TREATMENT KITBeautivity LLC4800a93b-7042-827b-e063-6294a90acd952026-03-25WarningsExact identifier
rxcui: 998483
Hermon Jock Itch Antifungal Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4dbc521c-2f5f-9736-e063-6294a90ad85d2026-03-23WarningsExact identifier
rxcui: 998483
AntifungalMICONAZOLE NITRATEDynarex Corporation4d384385-f3c5-09ba-e063-6394a90aec7f2026-03-17WarningsExact identifier
rxcui: 998483
Hermon Ringworm Treatment KitMICONAZOLE NITRATE 2% AND CLOTRIMAZOLE 1%Beautivity LLC4a9d9c6e-0e0f-d539-e063-6294a90acb572026-02-12WarningsExact identifier
rxcui: 998483
Kerova Miconazole NitrateMICONAZOLE NITRATEGuangzhou Bixiaoyu Trading Co., Ltd.3b8b5547-f8d1-9e48-e063-6294a90af4292026-02-12WarningsExact identifier
rxcui: 998483
Up and Up Miconazole 3MICONAZOLE NITRATETarget Corporation9a186532-ee69-428e-98a9-8ee69f4d667a2026-01-30WarningsExact identifier
rxcui: 998483
ProCure AntifungalMICONAZOLE NITRATE 2%Twin Med LLC3d380fe4-a870-cb55-e063-6394a90a9c902026-01-28WarningsExact identifier
rxcui: 998483
ElixirTripleGuard Triple AntibioticMICONAZOLE NITRATE CREAMELIXIR HEALTHCARE USA, LLC.0482ce9f-c98a-4f37-8b37-6df1738b6da32026-01-15WarningsExact identifier
rxcui: 998483
Desenex Antifungal Foot CreamMICONAZOLE NITRATECrown Laboratories, Inc.311abb56-e176-0510-e063-6294a90a97f52026-01-12WarningsExact identifier
rxcui: 998483
Private Label Antifungal Barrier Cream2% MICONAZOLE NITRATE CREAMSwiss-American CDMO, LLCe74bddea-c1ac-4e4e-84bd-5a9defb85b2d2026-01-08WarningsExact identifier
rxcui: 998483
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions23ca78c0-16a9-455c-99a7-b9a9a3affa602025-12-03WarningsExact identifier
rxcui: 998483
CAREALL Miconazole NitrateMICONAZOLE NITRATENew World Imports, Incbed775be-8bcb-44c2-9b9f-8bb25b4b24532025-12-01WarningsExact identifier
rxcui: 998483
PiYanPing AntifungalMICONAZOLE NITRATEZhejiang Dingtai Pharmaceutical Co., Ltd840364aa-d799-4163-a9e8-3f10c18f86ae2025-11-10WarningsExact identifier
rxcui: 998483
Selan AntifungalSELAN ANTIFUNGALTrividia Manufacturing Solutions, Inc8c7e51a0-0cd5-4ae3-a904-fad7ac6c1a292025-11-07WarningsExact identifier
rxcui: 998483
dg health miconazole 3MICONAZOLE NITRATEDolgencorp Incd84aa78d-b408-4d51-a54c-c66f6cef33f12025-11-01WarningsExact identifier
rxcui: 998483

Reported adverse events (FAERS/openFDA)#

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