Home NDC 59316-207 Biofreeze Overnight Roll-on
Product NDC 59316-207
11-digit product format 593160207
Labeler code 59316
Product ID 59316-207_51e06d5e-11fe-5814-e063-6294a90a2736
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 2023-03-16
Substance MENTHOL
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 Overnight Roll-on
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59316-207-14 Biofreeze Roll-On and Overnight Roll-On 74 mL in 1 BOTTLE GEL 74 mL 40 mg in 1mL 5 59316-207-14 Biofreeze Overnight Roll-on 74 mL in 1 BOTTLE GEL 74 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-207 BIOFREEZE OVERNIGHT ROLL-ON (MENTHOL) GEL [RB HEALTH (US) LLC] 2 Current NDC, 1 package rows 20241228_f67d7b7a-8922-73f6-e053-2995a90a2e80.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 82 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aruba Aloe Alcoholada LIDOCAINE HYDROCHLORIDE Aruba Aloe Balm NV f56c62b0-75db-4499-858e-54e10b0e140a 2025-08-07 Warnings Exact identifier application number: M017 SurviveX Hydrocortisone Cream HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. 3bd1da8d-5142-798c-e063-6294a90a7be6 2025-08-07 Warnings Exact identifier application number: M017 Arthcal SOOTHING PAIN RELIEF MASSAGE SOOTHING PAIN RELIEF MASSAGE Beijing JUNGE Technology Co., Ltd. 3524ad62-0ed6-f2e5-e063-6394a90a3283 2025-08-06 Warnings Exact identifier application number: M017 Alumier MD Intensive Recovery HYDROCORTISONE Alumier Labs d9b79ea1-6558-543c-e053-2995a90ae53e 2025-08-06 Warnings Exact identifier application number: M017 Good Neighbor Roll-on Pain Relief LIDOCAINE HCL Amerisource Bergen a0c3adbf-fa35-47c0-9db3-459ce9a106ac 2025-08-06 Warnings Exact identifier application number: M017 Good Neighbor Roll-on Menthol Pain Relief Gel MENTHOL Amerisource Bergen bd557323-0003-4ee6-b22d-a72d621c7de4 2025-08-05 Warnings Exact identifier application number: M017 Earthmed FS Pain relieving balm MENTHOL Earthmed LLC 3ba4e769-fec6-52d9-e063-6394a90a65d4 2025-08-05 Warnings Exact identifier application number: M017 HYDROCORTISONE HYDROCORTISONE HF Acquisition Co LLC, DBA HealthFirst 3ba6a5ec-fda2-b2a6-e063-6294a90ac9b6 2025-08-05 Warnings Exact identifier application number: M017 Kocowo Lidocaine Pain Relief Gel-Patch LIDOCAINE PAIN RELIEF GEL-PATCH Henan Enokon Medical Instrument Co., Ltd. 3b82989d-7cc3-23d3-e063-6294a90ae2a3 2025-08-03 Warnings Exact identifier application number: M017 Menthol pain relief patches MENTHOL Menthol pain relief patch 3b5fd718-3f86-f7a7-e063-6294a90a8c52 2025-08-02 Warnings Exact identifier application number: M017 Graphene Far Infrared Herbal Pain Relief Patches CORYDALIS RHIZOME Changsha Maocheng Trading Co., Ltd 3b604a3c-fe91-7096-e063-6394a90afe04 2025-08-02 Warnings Exact identifier application number: M017 Active Recovery Pain Relief CAMPHOR, MENTHOL Charlotte's Web, Inc. 3a9f9ca0-3d8a-796a-e063-6394a90a790c 2025-08-01 Warnings Exact identifier application number: M017 Active Recovery Pain Relief Stick CAMPHOR, MENTHOL Charlottes Web, Inc. 3aa037c6-6109-b52e-e063-6394a90a215b 2025-08-01 Warnings Exact identifier application number: M017 PM Recovery Pain Relief CAMPHOR, MENTHOL Charlotte's Web, Inc. 3aa08859-809d-de8c-e063-6394a90a8e25 2025-08-01 Warnings Exact identifier application number: M017 Wish ultra winter ice MENTHOL LJ Pharma b4c5487c-1314-4d63-96df-077e72e7ee95 2025-08-01 Warnings Exact identifier application number: M017 Rugged Fit Pain Relief Roll On MENTHOL, METHYL SALICYLATE SYSTEM4BOOK LLC 39d68734-981c-14d7-e063-6294a90a4919 2025-08-01 Warnings Exact identifier application number: M017 ICY FREEZE MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 28fdb049-b297-4358-9447-7d69ba879702 2025-08-01 Warnings Exact identifier application number: M017 Cortizone 10 Cooling HYDROCORTISONE Chattem, Inc. 14d9fce2-9f54-4204-83cb-161de8a303f0 2025-08-01 Warnings Exact identifier application number: M017 Bravado Labs Numbing LIDOCAINE HCL Prodigy Media Inc 8c43f5b5-b911-4a7a-b2d1-56a09c54b001 2025-07-30 Warnings Exact identifier application number: M017 Chimera GUARD LIDOCAINE PAIN RELIEFING PATCH Hangzhou Rongna Health Technology Co., Ltd. 3721c984-1993-6265-e063-6394a90af23f 2025-07-29 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 59316-207-14 59316020714 74 mL in 1 BOTTLE (59316-207-14) 74 ml 2023-03-16 No No Current