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 68 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aulief Topical Pain Reliever MENTHOL AND CAMOHOR China-Gel, LLC 8647dcc3-1dbc-1093-e053-2991aa0a1ab9 2025-11-04 Warnings Exact identifier application number: M017 China-Gel Topical Pain Reliever MENTHOL AND CAMOHOR (SYNTHETIC) China-Gel, LLC 254abae9-ef1b-5a90-e054-00144ff88e88 2025-11-04 Warnings Exact identifier application number: M017 Pain Relief Gel-Tube MENTHOL Bullet point LLC 42c93789-9758-54b7-e063-6394a90ac398 2025-11-04 Warnings Exact identifier application number: M017 Tattoo care TATTOO CARE CREAM Perfso (HK) Co., Limited 42d0f56f-9cb1-8e19-e063-6394a90aa3e0 2025-11-04 Warnings Exact identifier application number: M017 CORE RELIEF CAMPHOR, MENTHOL Copper Joint, LLC 42d17270-f58d-9d69-e063-6294a90a4078 2025-11-04 Warnings Exact identifier application number: M017 Lidocaine and Menthol LIDOCAINE AND MENTHOL Marcella Health d25f25ee-79f8-49e7-9715-0aae305b73e5 2025-11-03 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS NO TOUCH SPRAY Premier Brands of America Inc. 36481d67-2346-470b-e063-6294a90aae99 2025-11-03 Warnings Exact identifier application number: M017 Lidocaine Numbing Cream LIDOCAINE 5% YYBA Corp 1319ee69-8b3f-5815-e063-6294a90a5ad5 2025-11-03 Warnings Exact identifier application number: M017 Goodsense Extra Strength Cold and Hot Medicated MENTHOL Geiss, Destin and Dunn, Inc. 7585d111-775f-4fb6-a485-28cd99d88852 2025-10-31 Warnings Exact identifier application number: M017 Topcare Cold and Hot Medicated MENTHOL Topco Associates LLC 8739aedd-165c-5ae0-e053-2a91aa0afcd0 2025-10-31 Warnings Exact identifier application number: M017 CVS Medicated Heat 1 ct CAPSAICIN CVS Pharmacy, Inc. d41dce5b-e698-4930-8869-040b2a973f25 2025-10-31 Warnings Exact identifier application number: M017 Coralite Medicated Heat CAPSAICIN United Exchange Corp. a0b89c7e-80bc-43c4-840c-5fd567f60b21 2025-10-31 Warnings Exact identifier application number: M017 Dragon with Arnical Pain Relief MENTHOL Genomma Lab USA Inc. b4cbb7b6-cb71-9721-e053-2995a90a2b2c 2025-10-31 Warnings Exact identifier application number: M017 Gemachlich ZuHause NEUROPATHY SOLID Ointment. GEMACHLICH ZUHAUSE NEUROPATHY SOLID OINTMENT. Guangdong Quadrant Ecological Technology Co., Ltd. 425b1b9d-c33a-05e9-e063-6394a90a97a6 2025-10-30 Warnings Exact identifier application number: M017 Gemachlich ZuHause NEUROPATHY Spray. GEMACHLICH ZUHAUSE NEUROPATHY SPRAY. Guangdong Quadrant Ecological Technology Co., Ltd. 425b8259-af38-8d68-e063-6394a90a1120 2025-10-30 Warnings Exact identifier application number: M017 Family Care Muscle and Joint MENTHOL United Exchange Corp. 959af9f4-7188-91a1-e053-2995a90a4665 2025-10-30 Warnings Exact identifier application number: M017 CVS Maximum Strength Boil Relief BENZOCAINE CVS Pharmacy, Inc. 0761b866-af34-42bd-adc9-3d229170d01c 2025-10-30 Warnings Exact identifier application number: M017 CVS Cold and Hot MENTHOL CVS Pharmacy a44ca52d-fec8-0e8c-e053-2995a90a2e60 2025-10-30 Warnings Exact identifier application number: M017 CVS CAPSAICIN CAPSAICIN CVS PHARMACY 9b551fe3-3842-482a-9042-63de5ad39884 2025-10-30 Warnings Exact identifier application number: M017 TopCare Health Pain Relief MENTHOL, CAMPHOR, AND METHYL SALICYLATE Topco Associates LLC dac364ef-6dcd-3fc6-e053-2a95a90a9bb2 2025-10-30 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