Home NDC 59316-899 Biofreeze Ultraflex
Product NDC 59316-899
11-digit product format 593160899
Labeler code 59316
Product ID 59316-899_5348f92e-a770-de13-e063-6294a90adbcc
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine
Dosage form PATCH
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-15
Substance LIDOCAINE
Active strength .04 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE .04 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 98PI200987 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1737778 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 59316-899-04 Biofreeze Ultraflex 4 in 1 CARTON PATCH 4 4 59316-899-04 Biofreeze Ultraflex 2 g in 1 PATCH PATCH 2 4 59316-899-07 Biofreeze Ultraflex 2 g in 1 PATCH PATCH 2 4 59316-899-07 Biofreeze Ultraflex 1 in 1 POUCH PATCH 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-899 BIOFREEZE ULTRAFLEX (LIDOCAINE) PATCH [RB HEALTH (US) LLC] 3 Current NDC, 4 package rows 20250323_2655974b-a67d-9f07-e063-6294a90a54e8.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 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 59316-899-04 59316089904 4 PATCH in 1 CARTON (59316-899-04) / 2 g in 1 PATCH 4 patch 2025-01-15 No No Current 59316-899-07 59316089907 1 PATCH in 1 POUCH (59316-899-07) / 2 g in 1 PATCH 1 patch 2025-01-15 No No Current