Home NDC 59316-004 Biofreeze Flexible Relief Strip
Product NDC 59316-004
11-digit product format 593160004
Labeler code 59316
Product ID 59316-004_51b597cc-806d-e160-e063-6394a90ac1be
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form PATCH
Route TOPICAL
Labeler Reckitt Benckiser LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-31
Substance MENTHOL, UNSPECIFIED FORM
Active strength 56 mg/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 Flexible Relief Strip
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 56 mg/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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2566836 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 59316-004-01 Biofreeze Flexible Relief Strip 6 g in 1 PATCH PATCH 6 5 59316-004-01 Biofreeze Flexible Relief Strip 1 in 1 POUCH PATCH 1 5 59316-004-04 Biofreeze Flexible Relief Strip 4 in 1 CARTON PATCH 4 5 59316-004-04 Biofreeze Flexible Relief Strip 6 g in 1 PATCH PATCH 6 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59316-004 BIOFREEZE FLEXIBLE RELIEF STRIP (MENTHOL) PATCH [RB HEALTH (US) LLC] 4 Current NDC, Legacy NDC, 4 package rows 20241228_6ec26bae-e395-49aa-969e-8c653d6f0b27.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 85 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alocane Plus LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE Quest Products, Inc. 24538037-1d74-48a0-b909-98ecc57651fe 2025-07-17 Warnings Exact identifier application number: M017 Hydrocortisone anti-itch plus HYDROCORTISONE Wal-Mart Stores, Inc. a0c6e180-b385-4a9b-a9cf-84a551f533d0 2025-07-16 Warnings Exact identifier application number: M017 OTC Rescue Lidocaine Pain Relief Patch LIDOCAINE Veridian Healthcare 0e742fc6-5f76-d202-e063-6394a90acf31 2025-07-16 Warnings Exact identifier application number: M017 Itch Relief HYDROCORTISONE STRATEGIC SOURCING SERVICES LLC ae4b7cd6-8b5d-4d25-86f9-72260638bb94 2025-07-16 Warnings Exact identifier application number: M017 Freds Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE FRED'S, INC. 7502eebe-11c5-4e9e-b427-b87180a84349 2025-07-16 Warnings Exact identifier application number: M017 PROINNATE Numbing Cream MENTHOL Guangzhou Haishi Biological Technology Co., Ltd. 39688b2b-c1fe-cd86-e063-6394a90a5345 2025-07-16 Warnings Exact identifier application number: M017 Methyl Salicylate METHYL SALICYLATE ViolaCare, Inc. 8f0ba6e7-8aa4-443e-99ae-a255085ddfec 2025-07-15 Warnings Exact identifier application number: M017 TopCare Hydrocortisone Intensive Healing Formula HYDROCORTISONE Topco Associates LLC 7daafc44-e2a4-4f1b-bfca-3309a8e9a920 2025-07-15 Warnings Exact identifier application number: M017 Hydrocortisone Plus 12 Moisturizers HYDROCORTISONE TARGET Corporation 72c3889c-b743-4728-a315-6e4063e00200 2025-07-15 Warnings Exact identifier application number: M017 Shopko Hydrocortisone Maximum Strength HYDROCORTISONE Shopko Stores Operating Co., LLC 0431a6af-4c9a-4bbd-a535-cba31a5e53cc 2025-07-15 Warnings Exact identifier application number: M017 Freds Hydrocortisone with Aloe HYDROCORTISONE FRED'S, INC. 076503bf-8238-4739-bb1c-c385e72f8a96 2025-07-15 Warnings Exact identifier application number: M017 Shopko Hydrocortisone HYDROCORTISONE Shopko Stores Operating Co., LLC 92bcbde3-401a-4301-854e-c352852317d6 2025-07-15 Warnings Exact identifier application number: M017 TopCare Hydrocortisone HYDROCORTISONE Topco Associates LLC bd3585fa-3b48-49b7-8ad1-749bf1e31ed5 2025-07-15 Warnings Exact identifier application number: M017 Methyl Salicylate 25% Pain Relieving METHYL SALICYLATE Puretek Corporation 376797ff-cf13-a3c6-e063-6394a90a9de1 2025-07-15 Warnings Exact identifier application number: M017 TIGER BALM PAIN RELIEVING CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM Haw Par Healthcare Ltd. 440e97bc-bd97-4733-9955-643b18e7fb18 2025-07-15 Warnings Exact identifier application number: M017 Tiger Balm Pain Relieving Hydrogel Large CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM Haw Par Healthcare Ltd. 064d04ca-184d-492b-867c-beaa165ab3e0 2025-07-14 Warnings Exact identifier application number: M017 Methyl Salicylate 25% Cream METHYL SALICYLATE Medcore LLC 143f76bf-2de4-466a-8a6b-d6ab6314a2c3 2025-07-14 Warnings Exact identifier application number: M017 BLUESPRING Doctors Pain Formula Pain Relief MENTHOL ACA MANAGEMENT LLC 98f3f719-792f-4a93-95b1-90072e0f8bf4 2025-07-14 Warnings Exact identifier application number: M017 Shopko Anti-Itch DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE Shopko Stores Operating Co., LLC 130119eb-b87e-4a07-8d2a-317369bfa541 2025-07-14 Warnings Exact identifier application number: M017 Equate Hydrocortisone Intensive Healing Formula HYDROCORTISONE Wal-Mart Stores Inc. 635b49c4-54d2-4b6d-bee8-851fc2c7ca9c 2025-07-14 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 59316-004-01 59316000401 1 PATCH in 1 POUCH (59316-004-01) / 6 g in 1 PATCH 1 patch 2021-03-31 0000-00-00 No No Current 59316-004-04 59316000404 4 PATCH in 1 CARTON (59316-004-04) / 6 g in 1 PATCH 4 patch 2021-03-31 0000-00-00 No No Current