TEGASOLVE TOENAIL FUNGUS TREATMENT

Product NDC
85578-003
11-digit product format
855780003
Labeler code
85578
Product ID
85578-003_375b0515-1b20-23b8-e063-6294a90a9d68
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic Acid 25%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Zhengzhou Hangrui Network Technology Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-12
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
TEGASOLVE TOENAIL FUNGUS 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
85578-003-01TEGASOLVE TOENAIL FUNGUS TREATMENT30 mL in 1 BOTTLELIQUID301
85578-003-01TEGASOLVE TOENAIL FUNGUS TREATMENT1 in 1 BOXLIQUID11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN375b0515-1b1f-23b8-e063-6294a90a9d681
998329undecylenic acid 250 MG/ML Topical SolutionSCD375b0515-1b1f-23b8-e063-6294a90a9d681
998329undecylenic acid 25 % Topical SolutionSY375b0515-1b1f-23b8-e063-6294a90a9d681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85578-003-01855780003011 BOTTLE in 1 BOX (85578-003-01) / 30 mL in 1 BOTTLE1 bottle2025-06-12NoNoCurrent