Home NDC 59316-209 Biofreeze Roll-On and Overnight Roll-On
Product NDC 59316-209
11-digit product format 593160209
Labeler code 59316
Product ID 59316-209_51e076b8-984a-b24a-e063-6294a90ae9c0
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form KIT
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-01
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 Roll-On and Overnight Roll-On
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 415974 Internal RxNorm lookup 1111683 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 59316-205-14 Biofreeze Roll-On and Overnight Roll-On 74 mL in 1 BOTTLE GEL 74 mL 40 mg in 1mL 5 59316-207-14 Biofreeze Roll-On and Overnight Roll-On 74 mL in 1 BOTTLE GEL 74 mL 40 mg in 1mL 5 59316-209-14 Biofreeze Roll-On and Overnight Roll-On 1 in 1 BOTTLE KIT 1 5 59316-209-14 Biofreeze Roll-On and Overnight Roll-On 2 in 1 KIT KIT 2 5
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 100 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hempvana Maximum Strength Pain Relief Cream Extreme MENTHOL 16%, CAMPHOR 11% Telebrands Corp 2d54077e-4c8d-aaae-e063-6394a90adb41 2025-02-04 Warnings Exact identifier application number: M017 Capsaicin External Analgesic CAPSAICIN NuCare Pharmaceuticals,Inc. fd90a67d-d60d-a849-e053-6394a90a2cc8 2025-02-04 Warnings Exact identifier application number: M017 Rugby Muscle Rub Cream MUSCLE RUB CREAM NuCare Pharmaceuticals, Inc. 2d58c15a-5ddb-1b16-e063-6294a90a3fbb 2025-02-04 Warnings Exact identifier application number: M017 Cetilar MENTHOL 1.4% PharmaNutra Usa Corp. 2dd14bd4-b4e1-bc7d-e063-6394a90a1e59 2025-02-04 Warnings Exact identifier application number: M017 Stopain Extra Strength Continuous MENTHOL Troy Manufacturing, Inc. 0d199d39-5b47-4c7f-b83a-757f39aa17b6 2025-02-03 Warnings Exact identifier application number: M017 TheraCare Pain Relieving Lidocaine Cream LIDOCAINE HYDROCHLORIDE Veridian Healthcare 2d42192b-8889-a896-e063-6294a90a4fc8 2025-02-03 Warnings Exact identifier application number: M017 Tiger Balm Pain Relieving Muscle METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC) Haw Par Healthcare Ltd. 96b06d3f-8685-4314-ad7d-5d2720f4dde6 2025-02-03 Warnings Exact identifier application number: M017 Icy Hot Medicated No Mess Applicator MENTHOL Chattem, Inc. 4ce2b823-7ef5-4cca-a2d8-2fe781bc958e 2025-02-01 Warnings Exact identifier application number: M017 Cortizone 10 Intensive Healing Itch Relief Cream HYDROCORTISONE Chattem, Inc. cdbeb825-3152-4f74-9fd1-93bccfc0e31a 2025-02-01 Warnings Exact identifier application number: M017 Cortizone 10 Soothing Aloe Itch Relief HYDROCORTISONE Chattem, Inc. 1962abb3-6ca7-4934-9efe-20287b1c2a5b 2025-02-01 Warnings Exact identifier application number: M017 myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol MENTHOL Inspec Solutions LLC d4276749-eeff-28f7-e053-2a95a90a593d 2025-01-31 Warnings Exact identifier application number: M017 MyDerm Bite Relief BENZOCAINE Inspec Solutions LLC. 88615668-16b5-7840-e053-2a95a90a9208 2025-01-31 Warnings Exact identifier application number: M017 Maximum Strength Blue Emu Pain Relief Blu Emu TROLAMINE SALICYLATE Kingsway Pharmaceuticals dba NFI, LLC 5e02b820-e53a-42cb-abdb-2925617c29ca 2025-01-31 Warnings Exact identifier application number: M017 Sunset Novelties Herquake NUMBING LUBRICANT SUNSET INTIMATES GROUP INC 2ceeca3e-9197-9166-e063-6394a90ae908 2025-01-30 Warnings Exact identifier application number: M017 Magsoothium CBD Cooling Roll on Relief MENTHOL Ubu/Elements, Inc. 2cf05dcd-6a44-de08-e063-6394a90aaba0 2025-01-30 Warnings Exact identifier application number: M017 Meijer Vagicaine 20% BENZOCAINE AND 3% RESORCINOL CREAM Meijer, Inc. dac73a07-7569-4788-977a-f10d098da75d 2025-01-30 Warnings Exact identifier application number: M017 ZCort Ultra HYDROCORTISONE ACETATE 1% RxDino, LLC b68f8ada-58e8-e8e4-e053-2a95a90ab02d 2025-01-29 Warnings Exact identifier application number: M017 Lidocaine Pain Relieving Gel-Patch LIDOCAINE 4% Noble OTC LLC 12a3ce63-6fce-0993-e063-6294a90a40d5 2025-01-28 Warnings Exact identifier application number: M017 INTIMALE LIDOCAINE DELAY LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 5ddd7d56-bf51-462b-afcd-944861e49781 2025-01-28 Warnings Exact identifier application number: M017 CBD Clinic Relax Massage CAMPHOR ABACUS HEALTH PRODUCTS, INC. f0eae24e-09cf-0d2d-e053-2a95a90acedc 2025-01-28 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 Sample Exclude flag Status 59316-205-14 59316020514 74 mL in 1 BOTTLE 74 ml Historical 59316-207-14 59316020714 74 mL in 1 BOTTLE 74 ml Historical 59316-209-14 59316020914 2 BOTTLE in 1 KIT (59316-209-14) / 1 KIT in 1 BOTTLE * 74 mL in 1 BOTTLE (59316-205-14) * 74 mL in 1 BOTTLE (59316-207-14) 2 bottle 2026-04-01 No No Current