FUNGAL NAIL TREATMENT

Product NDC
85308-002
11-digit product format
853080002
Labeler code
85308
Product ID
85308-002_31dd1fb8-e662-eae8-e063-6394a90ab5e8
Type
HUMAN OTC DRUG
Nonproprietary name
FUNGAL NAIL TREATMENT
Dosage form
LIQUID
Route
TOPICAL
Labeler
Gaoye Marketing Inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-03
Substance
UNDECYLENIC ACID
Active strength
25 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FUNGAL NAIL TREATMENT
Listing expiration
2026-12-31

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
85308-002-01FUNGAL NAIL TREATMENT30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85308-002FUNGAL NAIL TREATMENT LIQUID [GAOYE MARKETING INC]1Current NDC, 1 package rows20250409_31dd1fb8-e661-eae8-e063-6394a90ab5e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN31dd1fb8-e661-eae8-e063-6394a90ab5e81
998329undecylenic acid 250 MG/ML Topical SolutionSCD31dd1fb8-e661-eae8-e063-6394a90ab5e81
998329undecylenic acid 25 % Topical SolutionSY31dd1fb8-e661-eae8-e063-6394a90ab5e81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85308-002-018530800020130 mL in 1 BOTTLE (85308-002-01) 30 ml2025-04-03NoNoCurrent