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 2 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PureWellness FUNGAL FUSION Antifungal and Antimicrobial KitFUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KITPureWellness LLC25db8c55-0fa9-4795-8e05-4d3a7aaf01482026-07-06WarningsExact identifier
rxcui: 998483
equate miconazole 1MICONAZOLE NITRATEWal-Mart Stores Inc5c5b0486-9ec2-4e14-a35c-80da8e62c59e2026-07-06WarningsExact identifier
rxcui: 998483
Terpenicol Antifungal CreamMICONAZOLE NITRATEBlaine Labs Inc.9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa2026-07-01WarningsExact identifier
rxcui: 998483
Kopa Haiku Ringworm Treatment CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd52cef8ec-6578-5e80-e063-6294a90ab4232026-06-30WarningsExact identifier
rxcui: 998483
Ringworm Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4805462b-aec6-78fe-e063-6394a90ae0662026-06-29WarningsExact identifier
rxcui: 998483
Aosorw Antifungal CreamMICONAZOLE NITRATE 2%SpineStatus LLC31f4b0eb-b8aa-7ccb-e063-6394a90ad9812026-06-29WarningsExact identifier
rxcui: 998483
Beilloso Balanitis ReliefMICONAZOLE NITRATE 2% BALANITIS RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4a71c26f-dee5-7b7f-e063-6294a90afcc12026-06-14WarningsExact identifier
rxcui: 998483
Charmpoo Antifungal CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMJiangxi Yudexi Pharmaceutical Co., LTD5214a267-0bab-59b8-e063-6394a90adb842026-06-12WarningsExact identifier
rxcui: 998483
BODYKOO ATHLETE FOOT CreamMICONAZOLE NITRATE2% ATHLETE FOOT CREAMJiangxi Yudexi Pharmaceutical Co., LTD53561903-54fe-f8ec-e063-6294a90a19fe2026-06-09WarningsExact identifier
rxcui: 998483
Miconazole CreamMICONAZOLE NITRATEAldermed Inc.4a7fc48a-c103-dc84-e063-6394a90ab80f2026-06-08WarningsExact identifier
rxcui: 998483
Charmpoo Antifungal CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMJiangxi Yudexi Pharmaceutical Co., LTD5368b131-7537-8679-e063-6394a90a67542026-06-04WarningsExact identifier
rxcui: 998483
Lasolex ACMICONAZOLE NITRATE 2% ANTIFUNGALPureTek Corporation52bb4bc1-e88f-f5ea-e063-6394a90ae1e82026-06-03WarningsExact identifier
rxcui: 998483
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd43cbad59-9899-ab3b-e063-6294a90a9e122026-06-02WarningsExact identifier
rxcui: 998483
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd431483f6-2386-9f5c-e063-6294a90af1042026-06-01WarningsExact identifier
rxcui: 998483
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd47cf1251-5965-045a-e063-6394a90ab04f2026-05-19WarningsExact identifier
rxcui: 998483
Recuren Plus Jock Itch CreamMICONAZOLE NITRATE 2%REGENEREN PLUS LTD450dab4d-168a-60b8-e063-6394a90ab3032026-05-08WarningsExact identifier
rxcui: 998483
Recuren Plus Antifungal CreamMICONAZOLE NITRATE 2%REGENEREN PLUS LTD3c28a93a-dd42-65b8-e063-6294a90ae6ab2026-05-07WarningsExact identifier
rxcui: 998483
Miconazole 3MICONAZOLE NITRATEMeijer Distribution Incc915a495-8eac-4a1a-83a4-c874682433c82026-05-07WarningsExact identifier
rxcui: 998483
RoyceDerm Tinea Antifungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC40089a7d-c893-4e90-e063-6294a90aa6f92026-05-06WarningsExact identifier
rxcui: 998483
RoyceDerm tinea ANTIFUNGAL .cream. and .soap.CREAM AND SOAPRoyceDerm LLC4f4ef2d0-98fa-e791-e063-6394a90a70452026-04-12WarningsExact identifier
rxcui: 998483

Reported adverse events (FAERS/openFDA)#

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