Antifungal Treatment Liquid 25 undeclylenic Acid

Product NDC
83691-000
11-digit product format
836910000
Labeler code
83691
Product ID
83691-000_2742c493-f552-4088-803f-ebe0286858ff
Type
HUMAN OTC DRUG
Nonproprietary name
UNDECYLENIC ACID
Dosage form
LIQUID
Route
TOPICAL
Labeler
SANSAR, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-01
Substance
UNDECYLENIC ACID
Active strength
250 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
Antifungal Treatment Liquid 25 undeclylenic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID250 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK3D86KJ24N
Rxcui998329

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83691-000-00Antifungal Treatment Liquid 25 undeclylenic Acid1 in 1 BOXLIQUID14
83691-000-00Antifungal Treatment Liquid 25 undeclylenic Acid15 mL in 1 BOTTLELIQUID154
83691-000-01Antifungal Treatment Liquid 25 undeclylenic Acid2 in 1 BOXLIQUID24
83691-000-01Antifungal Treatment Liquid 25 undeclylenic Acid15 mL in 1 BOTTLELIQUID154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83691-000ANTIFUNGAL TREATMENT LIQUID 25 UNDECLYLENIC ACID (UNDECYLENIC ACID) LIQUID [SANSAR, LLC]4Current NDC, 4 package rows20250406_2ae0f300-154e-44c8-bcc3-b5c334e661ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN2ae0f300-154e-44c8-bcc3-b5c334e661ac4
998329undecylenic acid 250 MG/ML Topical SolutionSCD2ae0f300-154e-44c8-bcc3-b5c334e661ac4
998329undecylenic acid 25 % Topical SolutionSY2ae0f300-154e-44c8-bcc3-b5c334e661ac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83691-000-00836910000001 BOTTLE in 1 BOX (83691-000-00) / 15 mL in 1 BOTTLE1 bottle2023-02-01NoNoHistorical
83691-000-01836910000012 BOTTLE in 1 BOX (83691-000-01) / 15 mL in 1 BOTTLE2 bottle2025-04-02NoNoHistorical