Clotrimazole

Product NDC
68788-8216
11-digit product format
687888216
Labeler code
68788
Product ID
68788-8216_0b5c7bee-f91f-483b-98a4-0dfe7e9efa50
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
333C
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-08
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
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/100g

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
68788-8216-3Clotrimazole30 g in 1 TUBECREAM305
68788-8216-3Clotrimazole1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8216-3GM - Gram68788-82167cb93532-b57a-4ead-b732-4bec4577b50312022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8216CLOTRIMAZOLE CREAM [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20240407_70e1efac-1738-43db-b19c-bbe02810b6e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN70e1efac-1738-43db-b19c-bbe02810b6e75
309367clotrimazole 10 MG/ML Topical CreamSCD70e1efac-1738-43db-b19c-bbe02810b6e75
309367clotrimazole 1 % Topical CreamSY70e1efac-1738-43db-b19c-bbe02810b6e75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8216-3687888216031 TUBE in 1 CARTON (68788-8216-3) / 30 g in 1 TUBE1 tube2022-09-080000-00-00NoNoCurrent