Extra Strength Nail Fungus Treatment

Product NDC
85966-001
11-digit product format
859660001
Labeler code
85966
Product ID
85966-001_3dced015-71fd-f6ab-e063-6294a90a0dc3
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID, TOLNAFTATE
Dosage form
LIQUID
Route
TOPICAL
Labeler
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-25
Substance
TOLNAFTATE; UNDECYLENIC ACID
Active strength
1; 25 g/100mL; 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
Extra Strength Nail Fungus Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100mL
UNDECYLENIC ACID25 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV, K3D86KJ24N
Rxcui2691548

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85966-001-01Extra Strength Nail Fungus Treatment30 mL in 1 BOTTLELIQUID303
85966-001-02Extra Strength Nail Fungus Treatment30 mL in 1 BOTTLELIQUID303
85966-001-02Extra Strength Nail Fungus Treatment2 in 1 BOXLIQUID23

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN3abc0892-e52b-a40f-e063-6294a90a0e353
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD3abc0892-e52b-a40f-e063-6294a90a0e353
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY3abc0892-e52b-a40f-e063-6294a90a0e353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85966-001-018596600010130 mL in 1 BOTTLE (85966-001-01) 30 ml2025-07-25NoNoHistorical
85966-001-02859660001022 BOTTLE in 1 BOX (85966-001-02) / 30 mL in 1 BOTTLE2 bottle2025-07-25NoNoHistorical