Home NDC 59316-992 Biofreeze
Product NDC 59316-992
11-digit product format 593160992
Labeler code 59316
Product ID 59316-992_32859ab1-5873-9a6f-e063-6294a90a86e3
Type HUMAN OTC DRUG
Nonproprietary name Menthol, Unspecified Form
Dosage form PATCH
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-03-04
Substance MENTHOL, UNSPECIFIED FORM
Active strength .05 g/g
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
Brand name suffix Menthol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM .05 g/g
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 420222 Internal RxNorm lookup 2109627 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-992 BIOFREEZE DAY AND OVERNIGHT (MENTHOL) KIT [RB HEALTH (US) LLC] 3 Current NDC, Legacy NDC 20241228_fb5c8f89-a720-ad32-e053-6294a90a2abe.zip 59316-992 BIOFREEZE MENTHOL (MENTHOL, UNSPECIFIED FORM) KIT [RB HEALTH (US) LLC] 3 Current NDC, Legacy NDC 20240927_3f2b1f48-2d78-4985-a046-9f72de5e1a9b.zip 59316-992 BIOFREEZE MENTHOL (MENTHOL, UNSPECIFIED FORM) PATCH [RB HEALTH (US) LLC] 3 Current NDC, Legacy NDC, 16 package rows 20240502_71a36691-9d9e-479d-bfdc-6f6b192ad2d0.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 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59316-992-04 59316099204 4 PATCH in 1 CARTON (59316-992-04) / 20 g in 1 PATCH 4 patch 2024-09-07 No No Current 59316-992-07 59316099207 1 PATCH in 1 POUCH (59316-992-07) / 9 g in 1 PATCH 1 patch 2022-03-04 0000-00-00 No No Current 59316-992-08 59316099208 12 PATCH in 1 CARTON (59316-992-08) / 9 g in 1 PATCH 12 patch 2022-03-04 0000-00-00 No No Current 59316-992-09 59316099209 5 PATCH in 1 CARTON (59316-992-09) / 9 g in 1 PATCH 5 patch 2022-03-04 0000-00-00 No No Current 59316-992-32 59316099232 1 PATCH in 1 POUCH (59316-992-32) / 20 g in 1 PATCH 1 patch 2022-03-04 0000-00-00 No No Current 59316-992-33 59316099233 1 PATCH in 1 POUCH (59316-992-33) / 13 g in 1 PATCH 1 patch 2022-03-04 0000-00-00 No No Current 59316-992-34 59316099234 15 PATCH in 1 CARTON (59316-992-34) / 9 g in 1 PATCH 15 patch 2024-10-01 No No Current 59316-992-36 59316099236 12 POUCH in 1 CARTON (59316-992-36) / 1 PATCH in 1 POUCH / 9 g in 1 PATCH 12 pouch 2022-03-04 0000-00-00 No No Current