Clotrimazole

Product NDC
69396-038
11-digit product format
693960038
Labeler code
69396
Product ID
69396-038_292a513a-420c-4ed2-e063-6294a90acae3
Type
HUMAN OTC DRUG
Nonproprietary name
Family Wellness Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-30
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
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/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
69396-038-05Clotrimazole1 in 1 BOXCREAM15
69396-038-05Clotrimazole15 g in 1 TUBECREAM155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-038CLOTRIMAZOLE (FAMILY WELLNESS CLOTRIMAZOLE) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5Current NDC, Legacy NDC, 2 package rows20241215_915759af-0d7b-6a87-e053-2a95a90acbd6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN915759af-0d7b-6a87-e053-2a95a90acbd65
309367clotrimazole 10 MG/ML Topical CreamSCD915759af-0d7b-6a87-e053-2a95a90acbd65
309367clotrimazole 1 % Topical CreamSY915759af-0d7b-6a87-e053-2a95a90acbd65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-038-05693960038051 TUBE in 1 BOX (69396-038-05) / 15 g in 1 TUBE1 tube2019-08-300000-00-00NoNoCurrent