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 ingredientCLOTRIMAZOLE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active IngredientActive Ingredient

INACTIVE INGREDIENT SECTION

Inactive IngredientInactive Ingredient

INDICATIONS & USAGE SECTION

Indication and UsageIndication and Usage

OTC - PURPOSE SECTION

PurposePurpose

DOSAGE & ADMINISTRATION SECTION

DosageDosage

WARNINGS SECTION

WarningsWarnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package labelPackage labelPackage labelPackage labelPackage labelPackage labelPackage labelPackage labelPackage labelPackage label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN1
309367clotrimazole 10 MG/ML Topical CreamSCD1
309367clotrimazole 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84722-3059-0ANTIFUNGAL1 g in 1 TUBECREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84722-3059ANTIFUNGAL (CLOTRIMAZOLE) CREAM [VIVE HEALTH LLC]1Current NDC, 1 package rows20250429_33db98f5-f6d9-742a-e063-6394a90a2a03.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84722-305984722-3059-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM METABISULFITE4VON5FNS3CIACT
CETETH-20I835H2IHHXIACT
LIGHT MINERAL OILN6K5787QVPIACT
CHLOROCRESOL36W53O7109IACT
CLOTRIMAZOLEG07GZ97H65ACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT

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
ANTIFUNGALCLOTRIMAZOLEVIVE HEALTH LLC33db98f5-f6d9-742a-e063-6394a90a2a032025-04-28WarningsExact identifier
ndc (package): 84722-3059-0
ndc (product): 84722-3059
ndc11 (package): 84722305900
spl id: 33db98f5-f6da-742a-e063-6394a90a2a03
spl set id: 33db98f5-f6d9-742a-e063-6394a90a2a03

Reported adverse events (FAERS/openFDA)#

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