FDA.reportPublic FDA data

PRO-EX

Product NDC
67234-014
Requested package NDC
67234-014-01
11-digit product format
672340014
Labeler code
67234
Product ID
67234-014_2af194fd-04d0-4c5b-b387-024a7903c0b1
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Natureplex, LLC
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2008-01-22
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
0 g/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67234-01467234-014-01IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

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
67234-014-01PRO-EXAnti Fungal42 g in 1 TUBECREAM4213

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65PRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
ClotrimazoleACTIVE MOIETYG07GZ97H65PRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EPRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWPRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
EDETATE TRISODIUMINACTIVE INGREDIENT420IP921MBPRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4PRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHPRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11
WATERINACTIVE INGREDIENT059QF0KO0RPRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-014PRO-EX ANTI FUNGAL (CLOTRIMAZOLE) CREAM [NATUREPLEX, LLC]13Legacy NDC, 1 package rows20250101_be06dd85-e342-4f07-b0e4-c49b3f6b3b4b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNbe06dd85-e342-4f07-b0e4-c49b3f6b3b4b13
309367clotrimazole 10 MG/ML Topical CreamSCDbe06dd85-e342-4f07-b0e4-c49b3f6b3b4b13
309367clotrimazole 1 % Topical CreamSYbe06dd85-e342-4f07-b0e4-c49b3f6b3b4b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67234-014-016723400140142 g in 1 TUBE (67234-014-01) 42 g2008-01-220000-00-00NoNoCurrent