Family Wellness Clotrimazole 1 Anti Fungal Cream

Product NDC
55319-980
11-digit product format
553190980
Labeler code
55319
Product ID
55319-980_2ef25a3a-88ac-a05e-e063-6294a90ae1ac
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
Family Dollar Stores, Inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
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
Family Wellness Clotrimazole 1 Anti Fungal Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-980-00Family Wellness Clotrimazole 1 Anti Fungal Cream1 in 1 BOXCREAM12
55319-980-00Family Wellness Clotrimazole 1 Anti Fungal Cream14 g in 1 TUBECREAM142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-980FAMILY WELLNESS CLOTRIMAZOLE 1 ANTI FUNGAL CREAM (CLOTRIMAZOLE) CREAM [FAMILY DOLLAR STORES, INC]2Current NDC, 2 package rows20250226_0667dd81-5633-494e-857e-45fa276fe72c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN0667dd81-5633-494e-857e-45fa276fe72c2
309367clotrimazole 10 MG/ML Topical CreamSCD0667dd81-5633-494e-857e-45fa276fe72c2
309367clotrimazole 1 % Topical CreamSY0667dd81-5633-494e-857e-45fa276fe72c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-980-00553190980001 TUBE in 1 BOX (55319-980-00) / 14 g in 1 TUBE1 tube2024-01-01NoNoCurrent