Clotrimazole

Product NDC
10135-671
11-digit product format
101350671
Labeler code
10135
Product ID
10135-671_40a87948-bcf6-0552-e063-6394a90a2d0d
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Marlex Pharmaceuticals Inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-01
Substance
CLOTRIMAZOLE
Active strength
1 g/mL
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
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
10135-671-81Clotrimazole10 mL in 1 BOTTLESOLUTION108
10135-671-81Clotrimazole1 in 1 CARTONSOLUTION18
10135-671-91Clotrimazole1 in 1 CARTONSOLUTION18
10135-671-91Clotrimazole30 mL in 1 BOTTLESOLUTION308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-671-81ML - Milliliter10135-67120b9cd43-b3b8-45ab-b185-aa435e24717a12019-01-24
10135-671-91ML - Milliliter10135-671c004140e-3550-406d-8686-1fc7bb50526d12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-671CLOTRIMAZOLE SOLUTION [MARLEX PHARMACEUTICALS INC]7Current NDC, Legacy NDC, 4 package rows20240719_d6e95c99-e055-436a-8ee6-40d6e199eaca.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-671-81101350671811 BOTTLE in 1 CARTON (10135-671-81) / 10 mL in 1 BOTTLE1 bottle2018-12-010000-00-00NoNoCurrent
10135-671-91101350671911 BOTTLE in 1 CARTON (10135-671-91) / 30 mL in 1 BOTTLE1 bottle2020-02-010000-00-00NoNoCurrent