FDA.reportPublic FDA data

Premier Value Antifungal

Product NDC
68016-474
11-digit product format
680160474
Labeler code
68016
Product ID
68016-474_49f1dae5-2b13-47e8-9a1a-cf6cbf834400
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
PHARMACY VALUE ALLIANCE, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-10
Substance
UNDECYLENIC ACID
Active strength
25 mg/30mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Premier Value Antifungal
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID25 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3D86KJ24NInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f5694ee5-616c-40f6-8da4-c3620dbcd6f7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-474-00Premier Value AntifungalMaximum Strength30 mL in 1 BOTTLE, WITH APPLICATORLIQUID306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-474-00ML - Milliliter68016-474230bf601-f1d0-469d-81e8-afd04c64b3fb12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-474PREMIER VALUE ANTIFUNGAL MAXIMUM STRENGTH (UNDECYLENIC ACID) LIQUID [PHARMACY VALUE ALLIANCE, LLC]6Current NDC, Legacy NDC, 1 package rows20241030_f5694ee5-616c-40f6-8da4-c3620dbcd6f7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 32 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arflom Toenail Fungus Treatment LiquidTOENAIL FUNGUS TREATMENT LIQUIDGuangzhou Qiexiran Cosmetics Co., Ltd.413e76b5-263c-62fa-e063-6294a90a92142025-10-15WarningsExact identifier
application number: M005
VTROUY Fungus Nail RenewalFUNGUS NAIL RENEWALGuangzhou Qiexiran Cosmetics Co., Ltd.413f6399-dda1-8dd9-e063-6394a90a573d2025-10-15WarningsExact identifier
application number: M005
Hongo KillerUNDECYLENIC ACIDEfficient Laboratories Incf647308a-ea6c-47a9-a124-60e7888afac22025-10-14WarningsExact identifier
application number: M005
Tripenicol SUNDECYLENIC ACIDTrifluent Pharma LLCb57500e1-ea6f-4043-99d6-326a7eb57f2f2025-10-14WarningsExact identifier
application number: M005
TriTolnacide CTOLNAFTATETrifluent Pharma LLC12b53c2a-b073-43db-88d9-ede8300626aa2025-10-14WarningsExact identifier
application number: M005
Tritolnacide STOLNAFTATETrifluent Pharma LLCb69ba7c9-03c1-4f5e-aa93-3ea1f2db15d82025-10-14WarningsExact identifier
application number: M005
Tripenicol CUNDECYLENIC ACIDTrifluent Pharma LLC0a7477da-370f-451f-8993-8c675c1686962025-10-14WarningsExact identifier
application number: M005
Povidone-Iodine PrepPOVIDONE-IODINEO&M HALYARD, INC.f3e0af11-39b6-44a0-8f84-a4b36631e8f02025-10-09WarningsExact identifier
application number: M005
seebeellar antifungal cream 2% miconazoleSEEBEELLAR ANTIFUNGAL CREAM 2% MICONAZOLEGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd40c491f6-43b4-534e-e063-6294a90a73d62025-10-09WarningsExact identifier
application number: M005
Hermon Antifungal Jock Itch Body WashTOLNAFTATE 1%Beautivity LLC409ef5c0-dfe5-f26a-e063-6294a90a27452025-10-08WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEMarlex Pharmaceuticals Incd6e95c99-e055-436a-8ee6-40d6e199eaca2025-10-08WarningsExact identifier
application number: M005
TM-ClotrimazoleCLOTRIMAZOLE 1%Singular Dreamer, Ltd dba True Markerd6a9755a-9ed1-4e7d-8e73-25c169d6c6b12025-10-06WarningsExact identifier
application number: M005
antibacterial body washSILVERGuangdong Quaker Daily Chemical Co., LTD3fff8d3e-1944-4813-e063-6294a90a1a1d2025-09-30WarningsExact identifier
application number: M005
Tobcharm Fungus Nail RenewalFUNGUS NAIL RENEWALGuangzhou Qiexiran Cosmetics Co., Ltd.4001247d-4704-8786-e063-6394a90a083a2025-09-30WarningsExact identifier
application number: M005
Silka AntifungalTOLNAFTATEGenomma Lab USAfb1dc636-837f-491c-97c1-e74288aebc272025-09-30WarningsExact identifier
application number: M005
Hydrocortisone 1%HYDROCORTISONEChain Drug Marketing Association Inc.3d48a3c6-b7d6-6794-e063-6294a90afff92025-09-29WarningsExact identifier
application number: M005
LEADER ATHLETES FOOT CLOTRIMAZOLECLOTRIMAZOLELEADERdcea717b-b097-4a40-8e38-05212731a7ef2025-09-29WarningsExact identifier
application number: M005
First Aid AntispeticBENZALKONIUM CHLORIDEUnishieldf72851ba-bbdd-5533-e053-6294a90a82162025-09-28WarningsExact identifier
application number: M005
Fungal Nail PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe861cc-c972-a328-e063-6294a90afc8f2025-09-28WarningsExact identifier
application number: M005
Tea Tree Oil Antifungal Foot CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3fe8fc55-bd64-a4a8-e063-6294a90ad18c2025-09-28WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-474-006801604740030 mL in 1 BOTTLE, WITH APPLICATOR (68016-474-00) 30 ml2019-04-100000-00-00NoNoCurrent