Thera plus Antifungal Clotrimazole

Product NDC
80684-039
11-digit product format
806840039
Labeler code
80684
Product ID
80684-039_08a0ce90-0c11-15f4-e063-6294a90a6ca7
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
FOURSTAR GROUP USA, INC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-30
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
Thera plus Antifungal Clotrimazole
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
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-039-01Thera plus Antifungal Clotrimazole14 g in 1 TUBECREAM142
80684-039-01Thera plus Antifungal Clotrimazole1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-039THERA PLUS ANTIFUNGAL CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [FOURSTAR GROUP USA, INC.]2Current NDC, Legacy NDC, 2 package rows20231027_1265be99-8922-4b76-bd63-19bfb42c3896.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN1265be99-8922-4b76-bd63-19bfb42c38962
309367clotrimazole 10 MG/ML Topical CreamSCD1265be99-8922-4b76-bd63-19bfb42c38962
309367clotrimazole 1 % Topical CreamSY1265be99-8922-4b76-bd63-19bfb42c38962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80684-039-01806840039011 TUBE in 1 BOX (80684-039-01) / 14 g in 1 TUBE1 tube2022-01-300000-00-00NoNoCurrent