Clotrimazole

Product NDC
85722-0026
11-digit product format
857220026
Labeler code
85722
Product ID
85722-0026_5115e8ac-db1f-5c4e-e063-6394a90a50ad
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
SOLUTION
Route
TOPICAL
Labeler
KJD Pharma Private Limited
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-13
Substance
CLOTRIMAZOLE
Active strength
1 g/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65

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
85722-0026-1Clotrimazole10 mL in 1 BOTTLESOLUTION101
85722-0026-2Clotrimazole30 mL in 1 BOTTLESOLUTION301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85722-0026-18572200260110 mL in 1 BOTTLE (85722-0026-1) 10 ml2024-09-13NoNoHistorical
85722-0026-28572200260230 mL in 1 BOTTLE (85722-0026-2) 30 ml2024-09-13NoNoHistorical