Antifungal 1% Clotrimazole Cream

Product NDC
64412-2010
11-digit product format
644122010
Labeler code
64412
Product ID
64412-2010_46274158-7d0f-1e12-e063-6294a90a5f4b
Type
HUMAN OTC DRUG
Nonproprietary name
Antifungal 1% Clotrimazole Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Twincraft Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-01
Substance
CLOTRIMAZOLE
Active strength
1 g/100mL
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
Antifungal 1% Clotrimazole Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100mL

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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64412-2010-1Antifungal 1% Clotrimazole Cream1 in 1 CARTONCREAM13
64412-2010-1Antifungal 1% Clotrimazole Cream29.5 mL in 1 TUBECREAM29.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64412-2010ANTIFUNGAL 1% CLOTRIMAZOLE CREAM CREAM [TWINCRAFT INC.]1Current NDC, 2 package rows20241218_29698d9e-8449-ceee-e063-6394a90a366e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN29698d9e-8449-ceee-e063-6394a90a366e3
309367clotrimazole 10 MG/ML Topical CreamSCD29698d9e-8449-ceee-e063-6394a90a366e3
309367clotrimazole 1 % Topical CreamSY29698d9e-8449-ceee-e063-6394a90a366e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64412-2010-1644122010011 TUBE in 1 CARTON (64412-2010-1) / 29.5 mL in 1 TUBE1 tube2024-10-01NoNoHistorical