FDA.reportPublic FDA data

CLOTRIMAZOL DUAL

Manufacturer
Laboratorios Química Son's, S.A. de C.V.
Effective date
2022-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:46

Label at a glance#

ProductCLOTRIMAZOL
Active ingredientCLOTRIMAZOLE
Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

creamcream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

prinprin

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73519-003-012023-07-28C16284748780-10191ceaa-6cbe-198a-e063-dbdaa90aec3eCLOTRIMAZOL
73519-004-012023-07-28C16284748780-10191ceaa-6cbe-198a-e063-dbdaa90aec3eCLOTRIMAZOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73519-003-01CLOTRIMAZOL3 g in 1 TUBECREAM32
73519-004-01CLOTRIMAZOL DUAL1 g in 1 TUBECREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73519-003CLOTRIMAZOL CREAM CLOTRIMAZOL DUAL CREAM [LABORATORIOS QUÍMICA SON'S, S.A. DE C.V.]2Legacy NDC, 1 package rows20220317_d5551abf-4d2a-35d2-e053-2a95a90a2782.zip
73519-004CLOTRIMAZOL CREAM CLOTRIMAZOL DUAL CREAM [LABORATORIOS QUÍMICA SON'S, S.A. DE C.V.]2Legacy NDC, 1 package rows20220317_d5551abf-4d2a-35d2-e053-2a95a90a2782.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73519-00373519-003-01
73519-00473519-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
PEG-20 SORBITAN STEARATEHD40WR33LCIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM BISULFITETZX5469Z6IIACT
METHYLPARABENA2I8C7HI9TIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 60CAL22UVI4MIACT
PEG-25 PROPYLENE GLYCOL STEARATEX21KPH4633IACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
PEG-20 SORBITAN STEARATEHD40WR33LCIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM BISULFITETZX5469Z6IIACT
METHYLPARABENA2I8C7HI9TIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 60CAL22UVI4MIACT
PEG-25 PROPYLENE GLYCOL STEARATEX21KPH4633IACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT

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
d5551abf-4d2b-35d2-e053-2a95a90a2782d5551abf-4d2a-35d2-e053-2a95a90a27822022-01-11Exact identifier
spl id: d5551abf-4d2b-35d2-e053-2a95a90a2782
spl set id: d5551abf-4d2a-35d2-e053-2a95a90a2782

Reported adverse events (FAERS/openFDA)#

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