Home NDC 80684-097 Thera Plus Cool and Heat Pain Relieving Gel Menthol
Product NDC 80684-097
11-digit product format 806840097
Labeler code 80684
Product ID 80684-097_0b61ea71-e589-bff5-e063-6394a90a2e50
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form LIQUID
Route TOPICAL
Labeler Fourstar Group USA, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-01
Substance MENTHOL
Active strength 160 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Thera Plus Cool and Heat Pain Relieving Gel Menthol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 160 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 253056 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 80684-097-00 Thera Plus Cool and Heat Pain Relieving Gel Menthol 74 mL in 1 BOTTLE LIQUID 74 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80684-097 THERA PLUS COOL AND HEAT PAIN RELIEVING GEL MENTHOL (MENTHOL) LIQUID [FOURSTAR GROUP USA, INC.] 2 Current NDC, 1 package rows 20240201_0a225714-ccb1-4676-e063-6294a90aeeb2.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 80 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HealthWise Overnight Menthol Patch MENTHOL Veridian Healthcare 6379f50d-2878-46ca-8acb-71c4554585e9 2025-08-28 Warnings Exact identifier application number: M017 Anti Itch Maximum Relief PRAMOXINE HYDROCHLORIDE AND MENTHOL Natureplex LLC 75de3d5e-ecbe-4d04-a39d-792200e6ee32 2025-08-28 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 3d5718f3-c175-6b64-e063-6394a90aa6f1 2025-08-27 Warnings Exact identifier application number: M017 ARCTIC HEAT MENTHOL, METHYL SALICYLATE Renu Laboratories, LLC 402df5c1-b8cb-17a2-e054-00144ff8d46c 2025-08-27 Warnings Exact identifier application number: M017 PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE HYDROCORTISONE Click Industries LLC 328c389c-7e05-4892-a9b3-b6a753f4935a 2025-08-25 Warnings Exact identifier application number: M017 Yeheal CAMPHOR, MENTHOL, ISOPROPYL ALCOHOL Shenzhen Yeheal Biotechnology Co., Ltd 3cf1bc74-3060-6d63-e063-6294a90a9f5c 2025-08-22 Warnings Exact identifier application number: M017 Dermedial Anti-Ouch MENTHOL Natures Formulae Health Products Ltd. 3ce29160-3964-e435-e063-6394a90abb38 2025-08-21 Warnings Exact identifier application number: M017 SUGARLOAF ORGANICS MENTHOL REVIVE MENTHOL RENU LABORATORIES, LLC fa2f9539-b703-a00b-e053-6394a90ae309 2025-08-21 Warnings Exact identifier application number: M017 Camphor 4% Plus Menthol 10% CAMPHOR 4% PLUS MENTHOL 10% PureTek Corporation 3cab26e4-e377-f26a-e063-6394a90a17af 2025-08-20 Warnings Exact identifier application number: M017 Capsaicin 0.035% Cream CAPSAICIN 0.035% CREAM Puretekcorp 3cbc73b6-8c58-8f23-e063-6394a90a71a3 2025-08-20 Warnings Exact identifier application number: M017 Game On MENTHOL, METHYL SALICYLATE Natural Essentials, Inc. 3cd20f1f-033f-f698-e063-6294a90a89eb 2025-08-20 Warnings Exact identifier application number: M017 ELAIMEI Numbing Cream LIDOCAINE 4% Shenzhen Shandian Jingling Technology Co., Ltd. 37ac13b2-ca55-0e28-e063-6294a90a000e 2025-08-19 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY FSA Store Inc. 3cd18f96-34f7-3f2c-e063-6294a90a3b7e 2025-08-19 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE SPRAY FSA Store Inc. 3ce24b87-55ac-0bbd-e063-6294a90ab582 2025-08-19 Warnings Exact identifier application number: M017 Fast Freeze Pain Relieving MENTHOL, UNSPECIFIED FORM NATURAL ESSENTIALS, INC. 15a26af1-ca5a-40fc-a411-6c0e8ae18fbb 2025-08-18 Warnings Exact identifier application number: M017 Orythia Maximum Strength Lidocaine Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 6d6b59f9-f614-4e3c-b07b-32b4591d39f2 2025-08-18 Warnings Exact identifier application number: M017 Ocean Potion Suncare Ice Plus Pain Relieving Soothing LIDOCAINE GNL BRANDS INTERNATIONAL, LLC 3c69654c-cba6-dfef-e063-6394a90ad479 2025-08-15 Warnings Exact identifier application number: M017 Earth Mama Medicated Herbal Lip Balm MENTHOL Eleeo Brands LLC 3c6c16bb-1f4b-b851-e063-6294a90a7404 2025-08-15 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Cintas First Aid & Safety 96f17095-31f3-4b8a-ab22-0caaefaa7476 2025-08-15 Warnings Exact identifier application number: M017 MedPride Cold Ice Analgesic Gel MENTHOL SHIELD LINE LLC 860a2c86-b240-4e0e-e053-2a91aa0a333a 2025-08-15 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 80684-097-00 80684009700 74 mL in 1 BOTTLE (80684-097-00) 74 ml 2024-02-01 No No Current