CLOTRIMAZOLE

Product NDC
84387-004
11-digit product format
843870004
Labeler code
84387
Product ID
84387-004_266d7b94-2955-4831-e063-6394a90a3f33
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
ALLIED TRADE LINK LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-08
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLOTRIMAZOLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309367

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
84387-004-01CLOTRIMAZOLE28.4 g in 1 TUBECREAM28.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84387-004CLOTRIMAZOLE CREAM [ALLIED TRADE LINK LLC]1Current NDC, 1 package rows20241115_266d7b94-2954-4831-e063-6394a90a3f33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN266d7b94-2954-4831-e063-6394a90a3f331
309367clotrimazole 10 MG/ML Topical CreamSCD266d7b94-2954-4831-e063-6394a90a3f331
309367clotrimazole 1 % Topical CreamSY266d7b94-2954-4831-e063-6394a90a3f331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84387-004-018438700040128.4 g in 1 TUBE (84387-004-01) 28.4 g2024-11-08NoNoHistorical