Extra Strength Toenail Renewal Pen

Product NDC
85966-012
11-digit product format
859660012
Labeler code
85966
Product ID
85966-012_4eeb59d2-3892-2e45-e063-6294a90a4fcf
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
2026-04-08
Substance
TOLNAFTATE; UNDECYLENIC ACID
Active strength
.01; .25 g/mL; g/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Extra Strength Toenail Renewal Pen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE.01 g/mL
UNDECYLENIC ACID.25 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV, K3D86KJ24N
Rxcui2691548

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85966-012-01Extra Strength Toenail Renewal Pen5 mL in 1 BOTTLE, DROPPERLIQUID51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN4eeb59d2-3891-2e45-e063-6294a90a4fcf1
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD4eeb59d2-3891-2e45-e063-6294a90a4fcf1
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY4eeb59d2-3891-2e45-e063-6294a90a4fcf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85966-012-01859660012015 mL in 1 BOTTLE, DROPPER (85966-012-01) 5 ml2026-04-08NoNoHistorical