SERYNTH ANTIFUNGAL NAIL TREATMENT PEN

Product NDC
85248-165
11-digit product format
852480165
Labeler code
85248
Product ID
85248-165_4d59116a-bcd1-9ed4-e063-6394a90a6dbd
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic acid 25% ANTIFUNGAL NAIL TREATMENT PEN
Dosage form
LIQUID
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-19
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
SERYNTH ANTIFUNGAL NAIL TREATMENT PEN
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
85248-165-01SERYNTH ANTIFUNGAL NAIL TREATMENT PEN3 in 1 BOXLIQUID31
85248-165-01SERYNTH ANTIFUNGAL NAIL TREATMENT PEN2.5 mL in 1 BOXLIQUID2.51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN4d59116a-bcd0-9ed4-e063-6394a90a6dbd1
998329undecylenic acid 250 MG/ML Topical SolutionSCD4d59116a-bcd0-9ed4-e063-6394a90a6dbd1
998329undecylenic acid 25 % Topical SolutionSY4d59116a-bcd0-9ed4-e063-6394a90a6dbd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-165-01852480165013 BOX in 1 BOX (85248-165-01) / 2.5 mL in 1 BOX3 box2026-03-19NoNoCurrent