EmoniNail Antifungal

Product NDC
65121-071
11-digit product format
651210071
Labeler code
65121
Product ID
65121-071_0973e425-f384-5656-e063-6394a90acb15
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pure Source, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-01
Substance
UNDECYLENIC ACID
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EmoniNail Antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK3D86KJ24N
Rxcui1251008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65121-071-08EmoniNail Antifungal24 mL in 1 BOTTLE, DROPPERLIQUID242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65121-071EMONINAIL ANTIFUNGAL (UNDECYLENIC ACID) LIQUID [PURE SOURCE, LLC]2Current NDC, Legacy NDC, 1 package rows20231106_458ff9e1-7751-4369-aa37-d6c4a071f270.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251008undecylenic acid 10 % Topical SolutionPSN458ff9e1-7751-4369-aa37-d6c4a071f2702
1251008undecylenic acid 100 MG/ML Topical SolutionSCD458ff9e1-7751-4369-aa37-d6c4a071f2702
1251008undecylenic acid 10 % Topical SolutionSY458ff9e1-7751-4369-aa37-d6c4a071f2702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65121-071-086512100710824 mL in 1 BOTTLE, DROPPER (65121-071-08) 24 ml2020-05-010000-00-00NoNoCurrent