Tolnaftate

Product NDC
69396-130
11-digit product format
693960130
Labeler code
69396
Product ID
69396-130_2a923ecc-8dad-73b1-e063-6394a90a7022
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate 1%
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-30
Substance
TOLNAFTATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tolnaftate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui103951

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-130-01Tolnaftate1 in 1 BOXCREAM12
69396-130-01Tolnaftate28.3 g in 1 TUBECREAM28.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-130TOLNAFTATE (TOLNAFTATE 1%) CREAM [TRIFECTA PHARMACEUTICALS USA, LLC]2Current NDC, 2 package rows20250101_091b907f-544a-86c9-e063-6294a90a5d87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSN091b907f-544a-86c9-e063-6294a90a5d872
103951tolnaftate 10 MG/ML Topical CreamSCD091b907f-544a-86c9-e063-6294a90a5d872
103951tolnaftate 1 % Topical CreamSY091b907f-544a-86c9-e063-6294a90a5d872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-130-01693960130011 TUBE in 1 BOX (69396-130-01) / 28.3 g in 1 TUBE1 tube2023-06-30NoNoCurrent