FDA.reportPublic FDA data

DERMFREE HELPS WITH NAGELPILZ

Product NDC
85248-115
11-digit product format
852480115
Labeler code
85248
Product ID
85248-115_50a3f408-63e2-47b3-e063-6294a90a8bfd
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate 1% Helps With Nagelpilz
Dosage form
LIQUID
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-08
Substance
TOLNAFTATE
Active strength
1 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
DERMFREE HELPS WITH NAGELPILZ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui313423

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-115-01DERMFREE HELPS WITH NAGELPILZ4 mL in 1 TUBELIQUID42
85248-115-02DERMFREE HELPS WITH NAGELPILZ3 in 1 BOXLIQUID32
85248-115-02DERMFREE HELPS WITH NAGELPILZ4 mL in 1 TUBELIQUID42
85248-115-03DERMFREE HELPS WITH NAGELPILZ3 in 1 BOXLIQUID32
85248-115-03DERMFREE HELPS WITH NAGELPILZ2.5 mL in 1 TUBELIQUID2.52

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313423tolnaftate 1 % Topical SolutionPSN4a4d9361-3633-59b2-e063-6294a90aa3ea2
313423tolnaftate 10 MG/ML Topical SolutionSCD4a4d9361-3633-59b2-e063-6294a90aa3ea2
313423tolnaftate 1 % Topical SolutionSY4a4d9361-3633-59b2-e063-6294a90aa3ea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-115-01852480115014 mL in 1 TUBE (85248-115-01) 4 ml2026-02-08NoNoHistorical
85248-115-02852480115023 TUBE in 1 BOX (85248-115-02) / 4 mL in 1 TUBE3 tube2026-02-08NoNoHistorical
85248-115-03852480115033 TUBE in 1 BOX (85248-115-03) / 2.5 mL in 1 TUBE3 tube2026-02-08NoNoHistorical