Toenail Fungus Treatment Extra Strength Pen

Product NDC
85038-001
11-digit product format
850380001
Labeler code
85038
Product ID
85038-001_4e77e84f-737b-3e6b-e063-6394a90a3bbc
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE, UNDECYLENIC ACID
Dosage form
LIQUID
Route
TOPICAL
Labeler
Lianjiang Shanlilai E-commerce Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-11
Substance
TOLNAFTATE; UNDECYLENIC ACID
Active strength
1; 25 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Toenail Fungus Treatment Extra Strength Pen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100mL
UNDECYLENIC ACID25 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV, K3D86KJ24N
Rxcui2691548

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85038-001-01Toenail Fungus Treatment Extra Strength Pen3 in 1 PACKAGELIQUID32
85038-001-01Toenail Fungus Treatment Extra Strength Pen5 mL in 1 BOTTLELIQUID52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85038-001TOENAIL FUNGUS TREATMENT EXTRA STRENGTH PEN (TOLNAFTATE, UNDECYLENIC ACID) LIQUID [LIANJIANG SHANLILAI E-COMMERCE CO., LTD.]1Current NDC, 2 package rows20241213_28fbcc50-a3ac-d6d1-e063-6294a90aa2b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN28fbcc50-a3ac-d6d1-e063-6294a90aa2b62
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD28fbcc50-a3ac-d6d1-e063-6294a90aa2b62
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY28fbcc50-a3ac-d6d1-e063-6294a90aa2b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85038-001-01850380001013 BOTTLE in 1 PACKAGE (85038-001-01) / 5 mL in 1 BOTTLE3 bottle2024-12-11NoNoHistorical