Home NDC 59316-869 Biofreeze
Product NDC 59316-869
11-digit product format 593160869
Labeler code 59316
Product ID 59316-869_51b57dbf-f47d-e694-e063-6294a90a7388
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form CREAM
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-03-21
Substance MENTHOL, UNSPECIFIED FORM
Active strength 100 mg/g
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 100 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 253020 Internal RxNorm lookup 2001133 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 59316-869-10 Biofreeze 85 g in 1 JAR CREAM 85 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-869 BIOFREEZE (MENTHOL) CREAM [RB HEALTH (US) LLC] 6 Current NDC, Legacy NDC, 1 package rows 20240112_a227213b-e89f-7144-e053-2a95a90a7e74.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 94 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mqforu Pain Patch PAIN PATCH Zhengzhou Miaoqi Medical Technology Co., Ltd. 1f878abd-54cd-1963-e063-6294a90a1884 2025-04-22 Warnings Exact identifier application number: M017 PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED ROLL ON LIDOCAINE, MENTHOL Compass Health Brands Corp. 2c25fa5e-9546-ba74-e063-6294a90aadf4 2025-04-22 Warnings Exact identifier application number: M017 PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED BALM LIDOCAINE, MENTHOL Compass Health Brands Corp. 2bd8cfb6-ab6c-9e04-e063-6294a90a2d52 2025-04-22 Warnings Exact identifier application number: M017 Maximum Strength 4% Lidocaine Patch LIDOCAINE Pharmheal 32e57c0f-d138-88dc-e063-6394a90ac085 2025-04-16 Warnings Exact identifier application number: M017 COLD HOT CHINESE RED TIGER PAIN RELIEF GeI-Patch MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 32b7d73c-a191-7843-e063-6394a90aa631 2025-04-14 Warnings Exact identifier application number: M017 Methyl Salicylate 25% Cream METHYL SALICYLATE MARCELLA HEALTH 32c153c7-de30-504e-e063-6294a90a4020 2025-04-14 Warnings Exact identifier application number: M017 Dollar General Cold-Hot Medicated Patches MENTHOL DOLGENCORP, LLC e13ab4d3-eb58-4874-925a-6a59df4dd29a 2025-04-14 Warnings Exact identifier application number: M017 AY BENDITO - PAIN RELIEF CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC b97f6b71-7de7-3217-e053-2a95a90aa426 2025-04-14 Warnings Exact identifier application number: M017 AY BENDITO - THERMOACTIVE CAMPHOR, MENTHOL AY BENDITO INTERNATIONAL, INC bbf0d85e-269d-0342-e053-2995a90ac63c 2025-04-14 Warnings Exact identifier application number: M017 Biofreeze Menthol MENTHOL, UNSPECIFIED FORM Reckitt Benckiser LLC 71a36691-9d9e-479d-bfdc-6f6b192ad2d0 2025-04-11 Warnings Exact identifier application number: M017 Eagle Medicated MENTHOL METHYL SALICYLATE Borden Company (Private) Limited da3358ae-8679-6045-e053-2a95a90a50e3 2025-04-10 Warnings Exact identifier application number: M017 Jointflex JOINTFLEX Strides Consumer LLC b82ec69c-bd00-400b-bd94-ac15fb620f9b 2025-04-09 Warnings Exact identifier application number: M017 Zepol Topical Analgesic CAMPHOR, MENTHOL Laboratorios Zepol S.A. ca20ade6-9b35-40bb-b3b2-fc3a0e1eece9 2025-04-09 Warnings Exact identifier application number: M017 Jointflex CAMPHOR Strides Consumer LLC cb5ca02b-0bc1-4b0b-b4b1-abef3222aa56 2025-04-09 Warnings Exact identifier application number: M017 Foster and Thrive Lidocaine Pain Relief Patch LIDOCAINE 4% Strategic Sourcing Services LLC 32456887-aa09-8912-e063-6394a90a4ae7 2025-04-08 Warnings Exact identifier application number: M017 MUSCLE MENTHOL WATER-JEL TECHNOLOGIES 1af399af-07b0-4899-9bcc-1e244b63b1cf 2025-04-08 Warnings Exact identifier application number: M017 Lidocaine with Menthol LIDOCAINE HCL AND MENTHOL Kareway Product, Inc. 9ee46a5b-d00c-4254-e053-2995a90aeb3a 2025-04-08 Warnings Exact identifier application number: M017 Foster and Thrive Lidocaine Pain Relief Patch LIDOCAINE 4% Strategic Sourcing Services LLC 324802c9-e2c2-bf74-e063-6394a90a8697 2025-04-08 Warnings Exact identifier application number: M017 OARS AND ALPS MUSCLE RECOVERY BALM MENTHOL, METHYL SALICYLATE Cosco International, Inc 8745802f-018d-4cf8-bbf3-3b04c8f54538 2025-04-08 Warnings Exact identifier application number: M017 NOVUM APR MENTHOL NOVUM SOLUTIONS INC 1b869a1f-5787-4d03-a546-43a8217b2b2c 2025-04-07 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59316-869-10 59316086910 85 g in 1 JAR (59316-869-10) 85 g 2020-03-21 0000-00-00 No No Current