LYSSERA Fungal Nail Renewal

Product NDC
85248-174
11-digit product format
852480174
Labeler code
85248
Product ID
85248-174_4dea6d08-b500-b29d-e063-6394a90afd03
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic Acid 25% Antifunga
Dosage form
LIQUID
Route
TOPICAL
Labeler
Jiangxi Yudexi Pharmaceutical Co., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-26
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
LYSSERA Fungal Nail Renewal
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
85248-174-01LYSSERA Fungal Nail Renewal3 mL in 1 TUBELIQUID31
85248-174-01LYSSERA Fungal Nail Renewal4 in 1 BOXLIQUID41

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN4dea6df4-e66b-c24a-e063-6294a90afca71
998329undecylenic acid 250 MG/ML Topical SolutionSCD4dea6df4-e66b-c24a-e063-6294a90afca71
998329undecylenic acid 25 % Topical SolutionSY4dea6df4-e66b-c24a-e063-6294a90afca71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85248-174-01852480174014 TUBE in 1 BOX (85248-174-01) / 3 mL in 1 TUBE4 tube2026-03-26NoNoCurrent