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 26 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bee Venom Toenail Fungus TreatmentBEE VENOM TOENAIL FUNGUS TREATMENTShenzhen Earth Surface Trading Co., Ltd.457c705a-9c49-c8c5-e063-6394a90a6aa32025-12-08WarningsExact identifier
application number: M005
Tolnaftate Antifungal PowderTOLNAFTATESCHOLL'S WELLNESS COMPANY LLC2a0e006b-60b1-41b9-a5d2-ff0e34b48ff52025-12-06WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions1e7e74f6-9bca-48ab-804a-a7a81df3b6082025-12-05WarningsExact identifier
application number: M005
Oiangna Tea Tree Oil AntifungalCLOTRIMAZOLE 1%Guangzhou Huixue Biotechnology Co., Ltd.453452a7-c613-6111-e063-6294a90aca812025-12-05WarningsExact identifier
application number: M005
Tinactin AntifungalTOLNAFTATEBayer HealthCare LLC.5f95be36-6efa-4dfb-9a40-88f4ce1de2b32025-12-05WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLC.c3b715a9-233a-401a-ba60-f78c1ddf1ded2025-12-05WarningsExact identifier
application number: M005
LotriminCLOTRIMAZOLEBayer HealthCare LLC.b584e17f-ed43-43bd-b643-dfa48edd78c62025-12-05WarningsExact identifier
application number: M005
Fungicure Night CreamCLOTRIMAZOLEKobayashi Healthcare International, Inc.43029403-2afd-cfa1-e063-6394a90a99a32025-12-04WarningsExact identifier
application number: M005
Lotrimin Daily Prevention DeoTOLNAFTATEBayer HealthCare LLC.9e8bfb78-ad81-93d0-e053-2995a90aa41d2025-12-04WarningsExact identifier
application number: M005
Lotrimin AF Jock ItchMICONAZOLE NITRATEBayer Healthcare LLC.0c53cf0f-767e-a422-e063-6394a90ab7642025-12-04WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLC.0a80a5b0-3216-46f6-8801-7066ef59aee42025-12-04WarningsExact identifier
application number: M005
Lotrimin AntifungalCLOTRIMAZOLEBayer HealthCare LLC.f9536683-3f32-4c71-9b6a-70f8611e3dcf2025-12-04WarningsExact identifier
application number: M005
Lotrimin AF DeodorantMICONAZOLE NITRATEBayer HealthCare LLC.0bee54eb-df2f-15fe-e063-6294a90a2fd22025-12-04WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLC.0beda157-efd2-5245-e063-6394a90a69112025-12-04WarningsExact identifier
application number: M005
Lotrimin AFMICONAZOLE NITRATEBayer Healthcare LLC.163996c6-af54-21ac-e063-6394a90ac05c2025-12-04WarningsExact identifier
application number: M005
Lotrimin Daily Prevent DeodorantTOLNAFTATEBayer HealthCare LLC.1bb961cd-b6e6-3aff-e063-6394a90a432e2025-12-04WarningsExact identifier
application number: M005
Tinactin DeodorantTOLNAFTATEBayer HealthCare LLC.1751d576-e94a-d7d1-e063-6294a90a03ff2025-12-04WarningsExact identifier
application number: M005
Tinactin Jock ItchTOLNAFTATEBayer HealthCare LLC163ab4df-6e4a-6239-e063-6294a90a1cd02025-12-04WarningsExact identifier
application number: M005
TinactinTOLNAFTATEBayer HealthCare LLCbb878f31-2189-4427-aacf-5bce96d759782025-12-04WarningsExact identifier
application number: M005
LotriminCLOTRIMAZOLEBayer HealthCare LLCda948ef3-3709-4bfc-9d17-f6f1ea3253432025-12-04WarningsExact 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