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 71 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Family Care Muscle Rub CAMPHOR, MENTHOL, AND METHYL SALICYLATE United Exchange Corp. 63006bb5-76e8-eb64-e053-2991aa0a95ad 2025-10-22 Warnings Exact identifier application number: M017 Winco Cold and Hot Medicated Patch Large MENTHOL WINCO FOODS, LLC af0d86c4-f74e-2dbe-e053-2a95a90a74c1 2025-10-22 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 064a6149-a0e2-8a73-e063-6394a90a7953 2025-10-22 Warnings Exact identifier application number: M017 Topical Analgesic MENTHOL Youngevity International Inc. b4693947-f5b3-6fd3-e053-2995a90ab581 2025-10-22 Warnings Exact identifier application number: M017 PAIN RELIEVING LIDOCAINE Medhome Pharma Inc 41cb1135-84e0-0c9a-e063-6294a90ada96 2025-10-22 Warnings Exact identifier application number: M017 KINKAN AMMONIA, CAMPHOR (NATURAL), MENTHOL KINKANDO CO., LTD . f2c0f3e1-792b-4798-bf6d-acd1bbefa261 2025-10-21 Warnings Exact identifier application number: M017 Coralite Muscle and Joint Pain Relief CAPSACIN United Exchange Corp. ba9a3d72-db7a-4dd0-9220-f43c9ed87114 2025-10-21 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Wrist MENTHOL United Exchange Corp. ae314478-b8ab-4e90-bd0a-7a882d5c1b2e 2025-10-21 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 85bd7658-e951-7daf-e053-2a91aa0a9f54 2025-10-21 Warnings Exact identifier application number: M017 Family Care Maximum Strength Medicated Anti Itch MENTHOL United Exchange Corp. 430b5753-3087-4cb1-bf54-0eedc3f4b1d5 2025-10-21 Warnings Exact identifier application number: M017 Family Care Anti-Itch HYDROCORTISONE United Exchange Corp. 8e4d46d8-7084-0666-e053-2995a90ad520 2025-10-21 Warnings Exact identifier application number: M017 Coralite Pain Relief CAMPHOR, MENTHOL, METHYL SALICYLATE United Exchange Corp. 69aec845-3d4c-d226-e053-2991aa0afd12 2025-10-21 Warnings Exact identifier application number: M017 WHITE FLOWER ANALGESIC BALM CAMPHOR, MENTHOL AND METHYL SALICYLATE HOE HIN PAK FAH YEOW MANUFACTORY LTD f3e3b8b5-b12b-49ac-9318-b0c358b136e9 2025-10-21 Warnings Exact identifier application number: M017 Mountain Ice Sports Recovery MENTHOL Mountainside Medical Equipment, Inc. 98638529-3c17-436e-901f-c8aea52bdab6 2025-10-20 Warnings Exact identifier application number: M017 Lip Clear Lysine Plus MENTHOL, UNSPECIFIED FORM Quantum, Inc. 21a5b4fb-baed-4766-9820-5c6051c14720 2025-10-20 Warnings Exact identifier application number: M017 Buzz Away Sting Soothe MENTHOL Quantum, Inc. 419e34ea-17b2-ec32-e063-6394a90a603d 2025-10-20 Warnings Exact identifier application number: M017 Family Care Anti-Itch HYDROCORTISONE United Exchange Corp. deb09e89-9794-89a7-e053-2a95a90abdf8 2025-10-20 Warnings Exact identifier application number: M017 Numbing Cream MENTHOL FlexiGo Inc 41571c8f-332b-f423-e063-6394a90a8897 2025-10-20 Warnings Exact identifier application number: M017 Soothing Nerve Therapy MENTHOL Wise Consumer Products 40829d6b-5005-7ec9-e063-6294a90a970e 2025-10-20 Warnings Exact identifier application number: M017 Numbing Cream MENTHOL FlexiGo Inc 4146fd51-b18c-393d-e063-6294a90a4d9a 2025-10-20 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