APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal Pen

Product NDC
84167-364
11-digit product format
841670364
Labeler code
84167
Product ID
84167-364_521a0e40-a219-fabb-e063-6294a90ae9a2
Type
HUMAN OTC DRUG
Nonproprietary name
APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal Pen
Dosage form
LIQUID
Route
TOPICAL
Labeler
Guangzhou Meixi Biotechnology Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-18
Substance
TOLNAFTATE; UNDECYLENIC ACID
Active strength
1; 25 g/1; g/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal Pen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/1
UNDECYLENIC ACID25 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV, K3D86KJ24N
Rxcui2691548

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84167-364-02APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal Pen2 in 1 BOXLIQUID21
84167-364-02APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal Pen6 in 1 BOTTLELIQUID61

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN521a0e40-a218-fabb-e063-6294a90ae9a21
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD521a0e40-a218-fabb-e063-6294a90ae9a21
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY521a0e40-a218-fabb-e063-6294a90ae9a21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84167-364-02841670364022 BOTTLE in 1 BOX (84167-364-02) / 6 LIQUID in 1 BOTTLE2 bottle2026-05-18NoNoHistorical