Home NDC 59316-834 Biofreeze Professional
Product NDC 59316-834
11-digit product format 593160834
Labeler code 59316
Product ID 59316-834_51e066bd-7c9d-326a-e063-6394a90a28b1
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, UNSPECIFIED FORM
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-01
Substance MENTHOL, UNSPECIFIED FORM
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 Professional
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 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 59316-834-20 Biofreeze Professional 118 mL in 1 BOTTLE AEROSOL, SPRAY 118 15 59316-834-22 Biofreeze Professional 2 in 1 CARTON AEROSOL, SPRAY 2 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-834 BIOFREEZE PROFESSIONAL (MENTHOL, UNSPECIFIED FORM) AEROSOL, SPRAY [RB HEALTH (US) LLC] 14 Current NDC, 2 package rows 20250207_00bba5d2-b0e0-701c-e063-6294a90a5741.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 42 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 CVS Pain Relief Lavender Scent MENTHOL 4% CVS 484b0833-9f8a-f155-e063-6294a90a1869 2026-01-13 Warnings Exact identifier application number: M017 EARTHS CARE ANTI-ITCH CAMPHOR (NATURAL), MENTHOL DLC Laboratories, Inc. d1eabb5f-7086-4ff0-a398-3703c9ecd441 2026-01-13 Warnings Exact identifier application number: M017 HealthWise Cold Therapy Menthol Pain Relief MENTHOL Veridian Healthcare 25e3d9cd-6ba3-4e06-8853-324b9d669248 2026-01-13 Warnings Exact identifier application number: M017 Pain Release MENTHOL Saje Natural Business Inc. 1ac2ed54-194c-4de2-8e7f-6e74ca32aa40 2026-01-13 Warnings Exact identifier application number: M017 Pain Release Joint and Arthritis Cream MENTHOL Saje Natural Business Inc. 18b24d75-17f7-1a35-e063-6394a90a55e0 2026-01-13 Warnings Exact identifier application number: M017 Pain Release MENTHOL Saje Natural Business Inc. a32b0950-3467-4e37-988d-104836af5971 2026-01-13 Warnings Exact identifier application number: M017 Pain Release MENTHOL Saje Natural Business Inc. 92eec6e7-0367-43c6-bd28-1762390a7114 2026-01-13 Warnings Exact identifier application number: M017 Pain Release MENTHOL Saje Natural Business Inc. 481a493b-0620-46ac-8228-e9964b7eb24b 2026-01-13 Warnings Exact identifier application number: M017 Restoral MENTHOL Saje Natural Business Inc. 5b6176c1-9ed9-1950-e053-2a91aa0a434e 2026-01-13 Warnings Exact identifier application number: M017 Aspercreme Lidocaine with Eucalyptus Essential Oil LIDOCAINE HCL Chattem, Inc. 03e247b4-a2e2-4354-a018-880f1bc987fd 2026-01-13 Warnings Exact identifier application number: M017 Aspercreme Lidocaine Foot (Diabetic) LIDOCAINE HYDROCHLORIDE Chattem, Inc. 2c33d15e-5032-46d9-bd98-5abc7df3bbe5 2026-01-13 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine Essential Oils Rosemary Mint LIDOCAINE Chattem, Inc. 9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab 2026-01-13 Warnings Exact identifier application number: M017 Capzasin HP Arthritis Pain Relief CAPSAICIN Chattem, Inc. 345c9159-0efe-436b-9068-3b717678936b 2026-01-13 Warnings Exact identifier application number: M017 Capzasin Quick Relief CAPSAICIN AND MENTHOL Chattem, Inc. d6c313a3-8dc6-4231-95b6-ac9399e1c1be 2026-01-13 Warnings Exact identifier application number: M017 Aspercreme Pain Relieving TROLAMINE SALICYLATE Chattem, Inc. 97dd587b-ecc3-4b4b-a116-6355d3c6ea6d 2026-01-13 Warnings Exact identifier application number: M017 Dr Wellskin Numbing Cream 4% LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 482f25cc-dee3-c3b6-e063-6294a90a8674 2026-01-12 Warnings Exact identifier application number: M017 BLT 2 LIDOCAINE HCL CENTURA PHARMACEUTICALS INC 41dc85ec-d79b-0a32-e054-00144ff8d46c 2026-01-12 Warnings Exact identifier application number: M017 Mineral Ice Pain Relieving MENTHOL Crown Laboratories 7b30076a-0af6-2f74-e053-2a91aa0ae08d 2026-01-12 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 59316-834-20 59316083420 118 mL in 1 BOTTLE (59316-834-20) 118 ml 2024-02-01 No No Current 59316-834-22 59316083422 2 BOTTLE in 1 CARTON (59316-834-22) / 118 mL in 1 BOTTLE (59316-834-20) 2 bottle 2025-03-15 No No Current