ANTIFUNGAL PEN

Product NDC
87571-001
11-digit product format
875710001
Labeler code
87571
Product ID
87571-001_4e85f338-ffd8-85b1-e063-6294a90a3c87
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Hanyang Qisheng (Shenzhen) Technology Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-03
Substance
TERBINAFINE HYDROCHLORIDE; UNDECYLENIC ACID
Active strength
1; 25 g/100mL; g/100mL
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ANTIFUNGAL PEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE1 g/100mL
UNDECYLENIC ACID25 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G, K3D86KJ24N
Rxcui2740011

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87571-001-01ANTIFUNGAL PEN5 mL in 1 BOTTLELIQUID51
87571-001-01ANTIFUNGAL PEN3 in 1 PACKAGELIQUID31
87571-001-02ANTIFUNGAL PEN6 in 1 PACKAGELIQUID61
87571-001-02ANTIFUNGAL PEN5 mL in 1 BOTTLELIQUID51

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2740011terbinafine hydrochloride 1 % / undecylenic acid 25 % Topical SolutionPSN4e85f338-ffd7-85b1-e063-6294a90a3c871
2740011terbinafine hydrochloride 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD4e85f338-ffd7-85b1-e063-6294a90a3c871
2740011terbinafine hydrochloride 1 % / undecylenic acid 25 % Topical SolutionSY4e85f338-ffd7-85b1-e063-6294a90a3c871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87571-001-01875710001013 BOTTLE in 1 PACKAGE (87571-001-01) / 5 mL in 1 BOTTLE3 bottle2026-04-03NoNoHistorical
87571-001-02875710001026 BOTTLE in 1 PACKAGE (87571-001-02) / 5 mL in 1 BOTTLE6 bottle2026-04-03NoNoHistorical