Home NDC 59316-206 Biofreeze Colorless Roll-On
Product NDC 59316-206
11-digit product format 593160206
Labeler code 59316
Product ID 59316-206_51b58e7e-a6c1-b40f-e063-6394a90a1f1e
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form GEL
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-01-17
Substance MENTHOL, UNSPECIFIED FORM
Active strength 40 mg/mL
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 Colorless Roll-On
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 40 mg/mL
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 415974 Internal RxNorm lookup 1111683 Internal RxNorm 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 59316-206-10 Biofreeze Colorless Roll-On 1 in 1 CARTON GEL 1 10 59316-206-10 Biofreeze Colorless Roll-On 89 mL in 1 BOTTLE, WITH APPLICATOR GEL 89 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-206 BIOFREEZE COLORLESS ROLL-ON (MENTHOL) GEL [RB HEALTH (US) LLC] 9 Current NDC, Legacy NDC, 2 package rows 20241228_a8d59d45-0e85-43d1-affd-bbe922c4acb1.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 77 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ink Scribd Numbing LIDOCAINE HCL Prodigy Media Inc 54173858-aff0-43b2-bc7b-c4ecab9bc3e5 2025-09-17 Warnings Exact identifier application number: M017 Inkorporated Numbing LIDOCAINE HCL Prodigy Media Inc 3017056c-f3c6-4300-8344-bf6e7d32e870 2025-09-17 Warnings Exact identifier application number: M017 TattooGirl Numbing LIDOCAINE HCL Prodigy Media Inc 6abe4540-f6c9-412a-83f3-682df7715057 2025-09-17 Warnings Exact identifier application number: M017 Dr Tatty Numbing LIDOCAINE HCL Prodigy Media Inc 5bb558c1-bf8f-4956-8732-e19720f62f31 2025-09-17 Warnings Exact identifier application number: M017 Burn Ease Cooling LIDOCAINE ProStat First Aid LLC ec201ca1-efa0-4797-aec3-115647c29abd 2025-09-17 Warnings Exact identifier application number: M017 MedFreeze Naturally Cool Pain Relief MENTHOL MEDKO LLC 240f2346-c585-4334-997c-45db6268d7c4 2025-09-15 Warnings Exact identifier application number: M017 MEDISTIK DUAL HOT AND COLD METHYL SALICYLATE, MENTHOL Natureteq Inc. ba5f4626-f077-4a28-8dcc-dacd50741ead 2025-09-15 Warnings Exact identifier application number: M017 MEDISTIK ICE MENTHOL, CAMPHOR Natureteq Inc. c1077744-7b9a-4536-8faf-e21994a43ea5 2025-09-15 Warnings Exact identifier application number: M017 Caring Mills Vaginal Anti-Itch Cream BENZOCAINE, RESORCINOL Veridian Healthcare cd379e74-2841-47e4-b95a-de1b341b397f 2025-09-15 Warnings Exact identifier application number: M017 Lidocaine-Pain-Relief-Patch LIDOCAINE-PAIN-RELIEF-PATCH Henan Enokon Medical Instrument Co., Ltd. 3ecfa867-50f6-d98a-e063-6394a90aefa0 2025-09-14 Warnings Exact identifier application number: M017 Meijer Hydrocortsione Cream HYDROCORTSIONE CREAM 1% Meijer Distribution Inc. 1cbddb7e-f2e3-0951-e063-6394a90a3d37 2025-09-12 Warnings Exact identifier application number: M017 JO Prolonger with Benzocaine BENZOCAINE CC Wellness LLC d955f612-1267-f1be-e053-2995a90a5345 2025-09-12 Warnings Exact identifier application number: M017 JO for Him Prolonger with Lidocaine LIDOCAINE CC Wellness LLC b12dc6a3-142d-3219-e053-2995a90aead0 2025-09-12 Warnings Exact identifier application number: M017 Walgreens Medicated Foot Powder MENTHOL Davion, Inc 58e1e7f7-6284-411f-9765-0e63eabca0f3 2025-09-12 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Amerisource Bergen 614f1e56-891f-4620-be10-0c075a1dbc3f 2025-09-11 Warnings Exact identifier application number: M017 Industrial Itch and Pain Relief DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE R & R Lotion, Inc 236415fc-f923-4a82-b54a-ecaf666dd2e0 2025-09-11 Warnings Exact identifier application number: M017 Eco Lips Menthol Medicated Lip Balm MENTHOL Eco Lips, Inc. fc4c25d6-6109-dfd8-e053-6394a90a4e91 2025-09-10 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE 1% Encube Ethicals, Inc. d6f5c0df-6262-4704-bb24-430f66bb2ca8 2025-09-09 Warnings Exact identifier application number: M017 Blue-Emu Lidocaine Pain Relief Cream LIDOCAINE CREAM 4% Kingsway Pharmaceuticals dba NFI, LLC 592811f2-e21c-6a58-e053-2991aa0a69a9 2025-09-09 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Unifirst First Aid Corporation 282ed5ef-8c2a-4092-9d99-1a7eee7a39e3 2025-09-09 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59316-206-10 59316020610 1 BOTTLE, WITH APPLICATOR in 1 CARTON (59316-206-10) / 89 mL in 1 BOTTLE, WITH APPLICATOR 2013-01-17 0000-00-00 No No Current