FDA.reportPublic FDA data

ANTIFUNGAL

Manufacturer
VIVE HEALTH LLC
Effective date
2025-04-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:51

Label at a glance#

ProductANTIFUNGAL
Active ingredientMICONAZOLE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

INACTIVE INGREDIENT SECTION

Inactive IngredientInactive Ingredient

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

OTC - PURPOSE SECTION

OTC PurposeOTC Purpose

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

WARNINGS SECTION

WarningsWarnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC Keep out of reach of childrenOTC Keep out of reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package label and Principle PanelPackage label and Principle PanelPackage labelPackage labelPackage labelPackage labelPackage labelPackage labelPackage LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998442miconazole nitrate 2 % Topical OintmentPSN1
998442miconazole nitrate 0.02 MG/MG Topical OintmentSCD1
998442miconazole nitrate 2 % Topical OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84722-3060-0ANTIFUNGAL1 g in 1 TUBEOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84722-3060ANTIFUNGAL (MICONAZOLE) OINTMENT [VIVE HEALTH LLC]1Current NDC, 1 package rows20250429_33d9c724-d4c4-2597-e063-6294a90aa5f3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84722-306084722-3060-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
CETEARETH-20YRC528SWUYIACT
MICONAZOLE7NNO0D7S5MACTIB
SODIUM CETEARYL SULFATE7ZBS06BH4BIACT
PETROLATUM4T6H12BN9UIACT
CETEARYL ALCOHOL2DMT128M1SIACT
CHLOROCRESOL36W53O7109IACT
IMIDAZOLIDINYL UREAM629807ATLIACT
CASTOR OILD5340Y2I9GIACT
GLYCERYL STEARATE230OU9XXE4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC33d9c724-d4c4-2597-e063-6294a90aa5f32025-04-28WarningsExact identifier
ndc (package): 84722-3060-0
ndc (product): 84722-3060
ndc11 (package): 84722306000
spl id: 33d9c724-d4c5-2597-e063-6294a90aa5f3
spl set id: 33d9c724-d4c4-2597-e063-6294a90aa5f3

Reported adverse events (FAERS/openFDA)#

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