Home NDC 59316-898 Biofreeze Ultraflex Plus
Product NDC 59316-898
11-digit product format 593160898
Labeler code 59316
Product ID 59316-898_53491d74-3bbc-40d5-e063-6394a90a7794
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine, Menthol
Dosage form PATCH
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-01-31
Substance LIDOCAINE; MENTHOL
Active strength .04; .01 g/g; g/g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 Biofreeze Ultraflex Plus
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE .04 g/g MENTHOL .01 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1249758 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59316-898-04 Biofreeze Ultraflex Plus 4 in 1 CARTON PATCH 4 2 59316-898-04 Biofreeze Ultraflex Plus 2 g in 1 PATCH PATCH 2 2 59316-898-07 Biofreeze Ultraflex Plus 2 g in 1 PATCH PATCH 2 2 59316-898-07 Biofreeze Ultraflex Plus 1 in 1 POUCH PATCH 1 2
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 18 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59316-898-04 59316089804 4 PATCH in 1 CARTON (59316-898-04) / 2 g in 1 PATCH 4 patch 2026-01-31 No No Current 59316-898-07 59316089807 1 PATCH in 1 POUCH (59316-898-07) / 2 g in 1 PATCH 1 patch 2026-01-31 No No Current