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 59 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SUNSET HEATING PAIN RELIEF ROLL-ON CAMPHOR SUNSET NOVELTIES, INC 45048936-f3c9-25f7-e063-6394a90ac4a9 2025-12-02 Warnings Exact identifier application number: M017 CAREALL Anti-Itch DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAM New World Imports, Inc 3a01f57a-ebc6-4724-b625-1d1ea4b85e73 2025-12-01 Warnings Exact identifier application number: M017 CareALL Arthritis and Muscle CAPSAICIN New World Imports, Inc 4867eac4-00ea-434e-b289-1c1ef0342c23 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc e2df8130-e7c8-4fde-a6d6-c71378991213 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc d04e473d-8bbc-475c-a0b1-ca5eed67fbc7 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Muscle Rub Ultra Strength MENTHOL, METHYL SALICYLATE New World Imports, Inc cba7c084-379f-4a16-aeba-b11ca6e20d8a 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Muscle Rub Ultra Strength MENTHOL, METHYL SALICYLATE New World Imports, Inc d066002d-8ceb-4d16-9744-d5ca25d2ad5a 2025-12-01 Warnings Exact identifier application number: M017 CAREALL Musle and Joint MENTHOL New World Imports, Inc 013beea4-b2c2-4e84-b4cb-3125ac48e8c0 2025-12-01 Warnings Exact identifier application number: M017 Capsaicin Cream CAPSAICIN A2A Integrated Pharmaceuticals, LLC 147f3594-7362-7a78-e063-6294a90a3e42 2025-11-30 Warnings Exact identifier application number: M017 Aquanil HC HYDROCORTISONE Person and Covey 6b9258e4-c7c4-765e-e053-2991aa0a9f4e 2025-11-29 Warnings Exact identifier application number: M017 Walgreen Pain Relieving Fragrance Free LIDOCAINE HYDROCHLORIDE WALGREENS CO. 62c50ded-3fc9-4f65-9bfb-1144ed2e36b4 2025-11-26 Warnings Exact identifier application number: M017 Itch Relief ITCH RELIEF GEL Neilmed Pharmaceuticals Inc. 44811828-c32e-17fc-e063-6294a90add48 2025-11-26 Warnings Exact identifier application number: M017 Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLON Clarion Brands LLC 4482d34d-eaca-5522-e063-6394a90a6afb 2025-11-26 Warnings Exact identifier application number: M017 Sohm Pain Away MENTHOL, CAMPHOR SOHM, Inc 86632acf-80ae-48d7-a0bb-7ec980326bae 2025-11-25 Warnings Exact identifier application number: M017 HealthWise Lidocaine Pain Relief LIDOCAINE 4% Veridian Healthcare 6f2332c0-e078-40a8-9564-f47d21bc491b 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON WARMING CAMPHOR Just Brands LLC 44779065-5f57-8f01-e063-6394a90a3f8e 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON COOLING MENTHOL Just Brands LLC 44786cb6-176e-cc6e-e063-6394a90a54ad 2025-11-25 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate EXTRA STRENGTH ITCH RELIEF VALU MERCHANDISERS, CO 3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff 2025-11-24 Warnings Exact identifier application number: M017 Menthol MAXIMUM STRENGTH MEDICATED FOOT POWDER VALU MERCHANDISERS, CO 89a5c4bb-442f-d3f0-e053-2a95a90a51bd 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d11ab8e-d3ea-c7ef-e063-6294a90ae0a3 2025-11-24 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