Thera plus Antifungal Tolnaftate

Product NDC
80684-040
11-digit product format
806840040
Labeler code
80684
Product ID
80684-040_08a0d819-d9c5-15e9-e063-6294a90acb44
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
CREAM
Route
TOPICAL
Labeler
FOURSTAR GROUP USA, INC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-30
Substance
TOLNAFTATE
Active strength
10 mg/g
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 Tolnaftate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui103951

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-040-01Thera plus Antifungal Tolnaftate14 g in 1 TUBECREAM142
80684-040-01Thera plus Antifungal Tolnaftate1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-040THERA PLUS ANTIFUNGAL TOLNAFTATE (TOLNAFTATE) CREAM [FOURSTAR GROUP USA, INC.]2Current NDC, Legacy NDC, 2 package rows20231027_c628dda8-7a6d-5f3a-e053-2995a90a35f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSNc628dda8-7a6d-5f3a-e053-2995a90a35f82
103951tolnaftate 10 MG/ML Topical CreamSCDc628dda8-7a6d-5f3a-e053-2995a90a35f82
103951tolnaftate 1 % Topical CreamSYc628dda8-7a6d-5f3a-e053-2995a90a35f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80684-040-01806840040011 TUBE in 1 BOX (80684-040-01) / 14 g in 1 TUBE1 tube2022-01-300000-00-00NoNoCurrent