Home NDC 59316-832 Biofreeze Day and Overnight
Product NDC 59316-832
11-digit product format 593160832
Labeler code 59316
Product ID 59316-832_51b59cc1-4a52-f6d3-e063-6394a90aea69
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form KIT
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-22
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 Day and Overnight
Listing expiration 2027-12-31 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59316-005-03 Biofreeze Day and Overnight 6 g in 1 PATCH PATCH 18 g in 3 0.3 g in 6g 3 59316-832-94 Biofreeze Day and Overnight 1 in 1 KIT KIT 1 3 59316-992-07 Biofreeze Day and Overnight 1 in 1 POUCH PATCH 0.05 g in 1g 3 59316-992-07 Biofreeze Day and Overnight 9 g in 1 PATCH PATCH 54 g in 6 0.05 g in 1g 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-832 BIOFREEZE DAY AND OVERNIGHT (MENTHOL) KIT [RB HEALTH (US) LLC] 3 Current NDC, 4 package rows 20241228_fb5c8f89-a720-ad32-e053-6294a90a2abe.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 87 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Neutrogena Sun Rescue After Sun Medicated Relief CAMPHOR (SYNTHETIC) Kenvue Brands LLC c95c5b64-b90f-1143-e053-2a95a90aa03c 2025-07-07 Warnings Exact identifier application number: M017 sunmark Hydrocortisone HYDROCORTISONE Strategic Sourcing Services LLC 210079e9-3d2f-4489-b468-b96b145034ed 2025-07-07 Warnings Exact identifier application number: M017 Relief Gel LIDOCAINE HCL Good Clean Love, Inc. e5fa2265-ccb7-750c-e053-2995a90aa51e 2025-07-07 Warnings Exact identifier application number: M017 Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 09ac2749-a60f-4039-8c80-a0d2eaf50c34 2025-07-07 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE Sun Pharmaceutical Industries, Inc. 2ada9ec2-1c28-4da2-8639-07b3193ffb32 2025-07-03 Warnings Exact identifier application number: M017 Hydrocortisone with Aloe HYDROCORTISONE Sun Pharmaceutical Industries, Inc. caa2fd64-e262-4d7c-ad8a-69f506feba8c 2025-07-03 Warnings Exact identifier application number: M017 Stopain Extra Strength MENTHOL Troy Manufacturing, Inc. 07e9a235-6d10-4407-8729-beaf936e97ad 2025-07-03 Warnings Exact identifier application number: M017 Blue Ice Topical Analgesic Gel ICE GEL International Wholesale 397cd306-078d-5b7d-e063-6294a90a8bbc 2025-07-03 Warnings Exact identifier application number: M017 LIDOCAINE LIDOCAINE, MENTHOL Vive Health LLC 236ccc6d-21b7-6153-e063-6394a90a4634 2025-07-02 Warnings Exact identifier application number: M017 AsperFlex MAX LIDOCAINE 4% WITH MENTHOL 1% Akron Pharma Inc. ccf6172b-350a-4b78-b844-f84bf17c491f 2025-07-02 Warnings Exact identifier application number: M017 METHYL SALICYLATE 25% METHYL SALICYLATE Oncora Pharma, LLC 3766e3a9-94a8-4c3e-e063-6394a90aa24a 2025-07-01 Warnings Exact identifier application number: M017 Diphenhydramine Hydrochloride and Zinc Acetate DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Sun Pharmaceutical Industries, Inc. c89e3de8-7d71-485c-8fc5-2832d6024f16 2025-07-01 Warnings Exact identifier application number: M017 Westlake Outdoor Pain and Itch Relieving LIDOCAINE 4% PAIN AND ITCH RELIEVING WESTLAKE HB PHARMA 3c563b28-4f4f-9d0c-e063-6294a90adf73 2025-07-01 Warnings Exact identifier application number: M017 Cortizone 10 Water Resistant HYDROCORTISONE Chattem, Inc. 118e55e7-241f-44c4-959e-09bf6221bd77 2025-07-01 Warnings Exact identifier application number: M017 Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 38c1616e-3b09-0669-e063-6294a90a2c86 2025-06-29 Warnings Exact identifier application number: M017 Plantar Fasciitis Cream CAMPHOR SOLALIA LLC 388f33c2-2bdf-ded8-e063-6294a90aeeac 2025-06-27 Warnings Exact identifier application number: M017 4 Lidocaine Topical Anesthetic LIDOCAINE RUGBY LABORATORIES 63327e57-f4c8-4ae6-9d28-cef8697bbdcc 2025-06-27 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate ANTI-ITCH CONTINUOUS SPRAY Wal-Mart Stores, Inc. 709c3bb8-5b36-4823-941a-45ddb3e431c4 2025-06-27 Warnings Exact identifier application number: M017 Burn Relief Professional Bio-Kool LIDOCAINE - 4% Kool-Down Inc. 827e9c69-4706-0ccf-e053-2991aa0aa1c1 2025-06-27 Warnings Exact identifier application number: M017 Lidocaine Patch LIDOCAINE Shenzhen Finona Information Technology Co., Ltd 3875bde5-2e1a-5fdf-e063-6294a90a3c0d 2025-06-26 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59316-005-03 59316000503 6 g in 1 PATCH 6 g Historical 59316-832-94 59316083294 1 KIT in 1 KIT (59316-832-94) * 1 PATCH in 1 POUCH (59316-992-07) / 9 g in 1 PATCH * 6 g in 1 PATCH (59316-005-03) 1 kit 2023-05-31 No No Current 59316-992-07 59316099207 1 in 1 POUCH Historical