EXTRA STRENGTH TOENAIIL RENEWAL PEN

Product NDC
85966-010
11-digit product format
859660010
Labeler code
85966
Product ID
85966-010_4eea5ee7-0efa-8d34-e063-6294a90af595
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 TOENAIIL 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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85966-010-01EXTRA STRENGTH TOENAIIL RENEWAL PEN5 mL in 1 BOTTLELIQUID51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN4eea5ee7-0ef9-8d34-e063-6294a90af5951
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD4eea5ee7-0ef9-8d34-e063-6294a90af5951
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY4eea5ee7-0ef9-8d34-e063-6294a90af5951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85966-010-01859660010015 mL in 1 BOTTLE (85966-010-01) 5 ml2026-04-08NoNoHistorical