Clotrimazole

Product NDC
69396-087
11-digit product format
693960087
Labeler code
69396
Product ID
69396-087_4bf9a459-7b08-9a01-e063-6294a90ac7b9
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
TRIFECTA PHARMACEUTICALS USA LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-08
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
69396-087-01Clotrimazole28.4 g in 1 TUBECREAM28.45
69396-087-01Clotrimazole1 in 1 BOXCREAM15
69396-087-55Clotrimazole5 in 1 BOXCREAM55
69396-087-55Clotrimazole28.4 g in 1 TUBECREAM28.45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-087CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]4Current NDC, Legacy NDC, 4 package rows20240330_e0a2a907-9c3a-4c4e-e053-2995a90abb91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNe0a2a907-9c3a-4c4e-e053-2995a90abb915
309367clotrimazole 10 MG/ML Topical CreamSCDe0a2a907-9c3a-4c4e-e053-2995a90abb915
309367clotrimazole 1 % Topical CreamSYe0a2a907-9c3a-4c4e-e053-2995a90abb915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-087-01693960087011 TUBE in 1 BOX (69396-087-01) / 28.4 g in 1 TUBE1 tube2022-06-040000-00-00NoNoCurrent
69396-087-55693960087555 TUBE in 1 BOX (69396-087-55) / 28.4 g in 1 TUBE5 tube2022-04-08NoNoCurrent