Clotrimazole

Product NDC
68788-4080
11-digit product format
687884080
Labeler code
68788
Product ID
68788-4080_d6f5c6b5-5e56-462f-8c47-7986ce53669d
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-25
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
68788-4080-1Clotrimazole10 mL in 1 BOTTLESOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4080-1ML - Milliliter68788-4080a3a92e12-dcea-4c1c-b270-117102c7ad7512026-04-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4080-16878840800110 mL in 1 BOTTLE (68788-4080-1) 10 ml2026-02-25NoNoHistorical