Home NDC 59316-833 Biofreeze
Product NDC 59316-833
11-digit product format 593160833
Labeler code 59316
Product ID 59316-833_51b57ded-2d7c-d540-e063-6394a90a4744
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form SPRAY
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-01
Substance MENTHOL
Active strength 105 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 105 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 1489073 Internal RxNorm lookup 1489074 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 59316-833-10 Biofreeze 89 mL in 1 BOTTLE SPRAY 89 12 59316-833-20 Biofreeze 118 mL in 1 BOTTLE SPRAY 118 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-833 BIOFREEZE (MENTHOL) SPRAY [RB HEALTH (US) LLC] 10 Current NDC, 2 package rows 20240202_00bb462a-27d0-6f74-e063-6394a90a90ec.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 41 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Maximum Strength Hydrocortisone Cream HYDROCORTISONE CREAM Walgreens 2112067c-0fbb-400c-9923-b932946e1a12 2026-01-14 Warnings Exact identifier application number: M017 Maximum Strength Hydrocortisone Cream HYDROCORTISONE CREAM Walgreens a7db0a6f-ceca-4e77-bad7-55c3c74413a7 2026-01-14 Warnings Exact identifier application number: M017 CVS Therapeutic Menthol Gel MENTHOL CVS Pharmacy a02605cd-40d1-4ea1-9828-0695f2d123aa 2026-01-14 Warnings Exact identifier application number: M017 Maximum Strength Cortisone HYDROCORTISONE OINTMENT CVS Pharmacy f25f2e14-4fc9-4c92-880d-e5f9279d4ecd 2026-01-14 Warnings Exact identifier application number: M017 Icy Hot with Lidocaine No-Mess MENTHOL AND LIDOCAINE Chattem, Inc. a2803c07-bf39-4028-9262-5082da25b46e 2026-01-14 Warnings Exact identifier application number: M017 Cortisone 10 Intensive Moisture Creme HYDROCORTISONE Chattem, Inc. 096a9af3-7e7c-4dae-bc22-44061c60d3c9 2026-01-14 Warnings Exact identifier application number: M017 Icy Hot Dry MENTHOL Chattem, Inc. 720a85cc-8e98-43f2-9cc8-5636ae09624f 2026-01-14 Warnings Exact identifier application number: M017 Gold Bond Extra Strength MENTHOL Chattem, Inc. 98ea15e6-972f-44a3-a1e4-abeae538d5a7 2026-01-14 Warnings Exact identifier application number: M017 Timing Pain Savior Fragrant Ginger Patch MENTHOL, METHYL SALICYLATE Timing Pharmaceutical Co., Ltd PABP Branch a0308e0e-1b47-42ab-88ac-b71ff3fa6c47 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 Easy Relief HYDROCORTISONE Chattem, Inc. beb73818-cd88-44ff-8ecd-b02b910b53b7 2026-01-14 Warnings Exact identifier application number: M017 diphenhydramine hcl and zinc acetate DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Padagis Israel Pharmaceuticals Ltd 6d7a7615-9ae7-4c55-8a84-dba746f535d7 2026-01-14 Warnings Exact identifier application number: M017 Timing Pain Savior Cool Herbal Patch MENTHOL, METHYL SALICYLATE Timing Pharmaceutical Co., Ltd PABP Branch 3b260be8-5e2a-4fba-85d6-2e6c64b97076 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 Feminine Itch Relief HYDROCORTISONE Chattem, Inc. c0c0c1fb-43c9-4903-bb3b-f0885619b8cc 2026-01-14 Warnings Exact identifier application number: M017 Icy Hot Pro Pain Relief Cream w/ microbeads MENTHOL, CAMPHOR Chattem, Inc. df5fd485-f583-46b7-a869-16ca2e17185c 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 Ultra Soothing Creme HYDROCORTISONE Chattem, Inc. 4b62615f-e713-42f2-8b9c-9eebf8d1b270 2026-01-14 Warnings Exact identifier application number: M017 Gold Bond Medicated Pain and Itch Relief LIDOCAINE HYDROCHLORIDE Chattem, Inc. 5767362c-83af-494e-a815-a13f2cb093ef 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 Fast Acting Itch Relief Cooling HYDROCORTISONE Chattem, Inc. 01cd77e3-380f-4487-ae6e-3ac45355d8a4 2026-01-14 Warnings Exact identifier application number: M017 hydrocortisone HYDROCORTISONE Padagis Israel Pharmaceuticals Ltd 0174411c-1b10-4298-b820-87b24065b118 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 Intensive Healing for Eczema HYDROCORTISONE Chattem, Inc. 31dc0f1f-ddd8-41dc-b669-b24655634d55 2026-01-14 Warnings Exact identifier application number: M017 Cortisone 10 Overnight Creme HYDROCORTISONE Chattem, Inc. ef2eda7e-d6a8-47e3-9d80-6074af6773dc 2026-01-14 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 59316-833-10 59316083310 89 mL in 1 BOTTLE (59316-833-10) 89 ml 2023-12-01 No No Current 59316-833-20 59316083320 118 mL in 1 BOTTLE (59316-833-20) 118 ml 2026-01-01 No No Current