Home NDC 68016-474 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 Ingredient Strength UNDECYLENIC ACID 25 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K3D86KJ24N Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68016-474-00 Premier Value AntifungalMaximum Strength 30 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-474 PREMIER VALUE ANTIFUNGAL MAXIMUM STRENGTH (UNDECYLENIC ACID) LIQUID [PHARMACY VALUE ALLIANCE, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241030_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 23 of 49 · 973 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-474-00 68016047400 30 mL in 1 BOTTLE, WITH APPLICATOR (68016-474-00) 30 ml 2019-04-10 0000-00-00 No No Current