Initial Drug Listing - Hermon Athletes foot 1% tolnaftate cream

Product NDC
85398-017
11-digit product format
853980017
Labeler code
85398
Product ID
85398-017_4c1657b9-b30d-928e-e063-6394a90a5dc4
Type
HUMAN OTC DRUG
Nonproprietary name
tolnaftate 1%
Dosage form
CREAM
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-31
Substance
TOLNAFTATE
Active strength
.6 g/60g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Initial Drug Listing - Hermon Athletes foot 1% tolnaftate cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE.6 g/60g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui103951

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-017-01Initial Drug Listing - Hermon Athletes foot 1% tolnaftate cream60 g in 1 CARTONCREAM603
85398-017-02Initial Drug Listing - Hermon Athletes foot 1% tolnaftate cream57 g in 1 TUBECREAM573
85398-017-02Hermon Athletes foot Tolnaftate 1% kit57 g in 1 TUBECREAM57 g0.57 g in 57g2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSN4141cca0-1650-6e00-e063-6394a90a13e33
103951tolnaftate 10 MG/ML Topical CreamSCD4141cca0-1650-6e00-e063-6394a90a13e33
103951tolnaftate 1 % Topical CreamSY4141cca0-1650-6e00-e063-6394a90a13e33
1807715tolnaftate 1 % Medicated Bar SoapPSN4142f490-c4b5-a9f3-e063-6394a90ab75e2
103951tolnaftate 1 % Topical CreamPSN4142f490-c4b5-a9f3-e063-6394a90ab75e2
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD4142f490-c4b5-a9f3-e063-6394a90ab75e2
103951tolnaftate 10 MG/ML Topical CreamSCD4142f490-c4b5-a9f3-e063-6394a90ab75e2
1807715tolnaftate 1 % Medicated Bar SoapSY4142f490-c4b5-a9f3-e063-6394a90ab75e2
103951tolnaftate 1 % Topical CreamSY4142f490-c4b5-a9f3-e063-6394a90ab75e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85398-017-018539800170160 g in 1 CARTON (85398-017-01) 60 g2025-10-31NoNoCurrent
85398-017-028539800170257 g in 1 TUBE (85398-017-02) 57 g2025-10-31NoNoCurrent