Home NDC 59316-101 Biofreeze
Product NDC 59316-101
11-digit product format 593160101
Labeler code 59316
Product ID 59316-101_51b434c9-228b-2c05-e063-6394a90a1e94
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 2016-08-25
Substance MENTHOL, UNSPECIFIED FORM
Active strength 35 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 35 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 808955 Internal RxNorm lookup 1043451 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-101 BIOFREEZE (MENTHOL) GEL [RB HEALTH (US) LLC] 42 Current NDC, Legacy NDC, 12 package rows 20241228_684faf63-5e44-4471-8384-e8fa7c0d842a.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 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join METHYL SALICYLATE 25% METHYL SALICYLATE Oncora Pharma, LLC 3c4bc55d-6582-3b5e-e063-6394a90a994c 2025-08-13 Warnings Exact identifier application number: M017 Lidocaine 3% LIDOCAINE HCL 3% PureTek Corporation 3bc94d52-fe52-9fd6-e063-6294a90a4340 2025-08-12 Warnings Exact identifier application number: M017 Fast Freeze MENTHOL Natural Essentials Inc. d8c42c8d-6ce0-43bf-b165-41979f3d8f79 2025-08-12 Warnings Exact identifier application number: M017 Careland X-large Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. a6867506-4a46-47b1-b5b6-bfedb59dfde6 2025-08-11 Warnings Exact identifier application number: M017 Dermedial Anti-Ouch MENTHOL Saje Natural Business Inc. 3c194b8f-cfa5-11e3-e063-6394a90a92de 2025-08-11 Warnings Exact identifier application number: M017 Thera Plus Extra Strength Muscle Rub Topical Analgesic MENTHOL FOURSTAR GROUP USA, INC. 8a3b6adf-afbb-4d77-a19b-a6514ebd3b50 2025-08-11 Warnings Exact identifier application number: M017 EARTHS CARE ARTHRITIS CAPSAICIN DLC Laboratories, Inc. 9460674b-057e-40b9-a0f9-ca3d92068d4f 2025-08-11 Warnings Exact identifier application number: M017 LILAS PERIOD MENTHOL Lilas Wellness, Inc. 5ea53b4b-45e6-48a7-8090-09c3a21e7f63 2025-08-11 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel Roll-On LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 31639407-0f11-bde2-e063-6294a90af694 2025-08-10 Warnings Exact identifier application number: M017 Chinese Red Tiger Lidocaine Patches LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 20cd369c-3e98-3d8f-e063-6394a90a0824 2025-08-10 Warnings Exact identifier application number: M017 Treatonic LIDOCAINE PAIN RELIEF LIDOCAINE 4% 100 KARMA INC 3bd66b03-ac82-2d45-e063-6294a90a610a 2025-08-08 Warnings Exact identifier application number: M017 Capsaicin 0.025% CAPSAICIN 0.025% Advanced Rx of Tennessee, LLC 3bdcef94-d06f-9152-e063-6294a90a6072 2025-08-08 Warnings Exact identifier application number: M017 MENTHOL 5% MENTHOL 5% Advanced Rx of Tennessee, LLC 3bdd0c52-29d8-ab67-e063-6294a90a9c45 2025-08-08 Warnings Exact identifier application number: M017 Methyl Salicylate 25% Cream METHYL SALICYLATE Advanced Rx of Tennessee, LLC 3bdd3015-349a-0fac-e063-6394a90afe41 2025-08-08 Warnings Exact identifier application number: M017 LIDOCAINE 4% LIDOCAINE 4% Advanced Rx of Tennessee, LLC 3bdd6b3d-7180-288c-e063-6394a90a1785 2025-08-08 Warnings Exact identifier application number: M017 Good Sense Pain Relief Roll On LIDOCAINE HCL Geiss, Destin & Dunn, Inc 38e76fd6-e5fb-493c-e063-6294a90afed4 2025-08-08 Warnings Exact identifier application number: M017 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
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 59316-101-10 59316010110 5 mL in 1 PACKET (59316-101-10) 5 ml 2016-08-25 0000-00-00 No No Current 59316-101-11 59316010111 30 mL in 1 BOTTLE (59316-101-11) 30 ml 2016-08-25 0000-00-00 No No Current 59316-101-12 59316010112 59 mL in 1 TUBE (59316-101-12) 59 ml 2016-08-25 0000-00-00 No No Current 59316-101-13 59316010113 59 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-13) 59 ml 2016-08-25 0000-00-00 No No Current 59316-101-15 59316010115 89 mL in 1 BOTTLE, WITH APPLICATOR (59316-101-15) 89 ml 2016-08-25 0000-00-00 No No Current 59316-101-19 59316010119 3 mL in 1 PACKET (59316-101-19) 3 ml 2022-01-01 0000-00-00 No No Current 59316-101-20 59316010120 118 mL in 1 TUBE (59316-101-20) 118 ml 2016-08-25 0000-00-00 No No Current 59316-101-21 59316010121 81 mL in 1 TUBE 81 ml Historical 59316-101-25 59316010125 118 mL in 1 TUBE, WITH APPLICATOR (59316-101-25) 118 ml 2016-08-25 2021-12-31 No No Current 59316-101-30 59316010130 473 mL in 1 BOTTLE, PUMP (59316-101-30) 473 ml 2016-08-25 0000-00-00 No No Current 59316-101-40 59316010140 946 mL in 1 BOTTLE, PUMP (59316-101-40) 946 ml 2016-08-25 0000-00-00 No No Current 59316-101-50 59316010150 3785 mL in 1 BOTTLE, PUMP (59316-101-50) 3785 ml 2016-08-25 0000-00-00 No No Current