Kakalsa TOENAIL FUNGUS TREATMENT

Product NDC
85248-204
11-digit product format
852480204
Labeler code
85248
Product ID
85248-204_5123c0c3-bba9-d61c-e063-6394a90aab70
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic Acid 25% TOENAIL FUNGUS TREATMENT
Dosage form
LIQUID
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-06
Substance
UNDECYLENIC ACID
Active strength
25 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
Kakalsa TOENAIL FUNGUS TREATMENT
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID25 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK3D86KJ24N
Rxcui998329

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-204-01Kakalsa TOENAIL FUNGUS TREATMENT3 mL in 1 TUBELIQUID31
85248-204-01Kakalsa TOENAIL FUNGUS TREATMENT4 in 1 BOXLIQUID41
85248-204-02Kakalsa TOENAIL FUNGUS TREATMENT56 mL in 1 BOTTLELIQUID561

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN5123c0c3-bba8-d61c-e063-6394a90aab701
998329undecylenic acid 250 MG/ML Topical SolutionSCD5123c0c3-bba8-d61c-e063-6394a90aab701
998329undecylenic acid 25 % Topical SolutionSY5123c0c3-bba8-d61c-e063-6394a90aab701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-204-01852480204014 TUBE in 1 BOX (85248-204-01) / 3 mL in 1 TUBE4 tube2026-05-06NoNoHistorical
85248-204-028524802040256 mL in 1 BOTTLE (85248-204-02) 56 ml2026-05-06NoNoHistorical