Home NDC 80684-101 Thera Plus Cold Therapy Pain Relieving Menthol
Product NDC 80684-101
11-digit product format 806840101
Labeler code 80684
Product ID 80684-101_0b23e32c-9248-271c-e063-6294a90a1f5c
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL
Dosage form GEL
Route TOPICAL
Labeler Fourstar Group USA, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-01
Substance MENTHOL
Active strength 40 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 Cold Therapy Pain Relieving Menthol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 40 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 415974 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 80684-101-00 Thera Plus Cold Therapy Pain Relieving Menthol 74 mL in 1 BOTTLE GEL 74 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80684-101 THERA PLUS COLD THERAPY PAIN RELIEVING MENTHOL (MENTHOL) GEL [FOURSTAR GROUP USA, INC.] 2 Current NDC, 1 package rows 20240201_0a462c91-5300-e282-e063-6394a90a4cc2.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 33 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tylenol Precise Cooling Pain Relieving LIDOCAINE, MENTHOL Kenvue Brands LLC fc0a3404-b174-3952-e053-6294a90a1e02 2026-02-16 Warnings Exact identifier application number: M017 Aloe Vera Gel LIDOCAINE HCL Valu Merchandisers Company 87ee2b4f-d640-4cec-9f48-1d8aa54434e9 2026-02-16 Warnings, Adverse reactions Exact identifier application number: M017 Hemp Magic Fast-Acting Pain Relief Cream MENTHOL Nexxus Capital LLC 4af69640-1413-868b-e063-6394a90a3989 2026-02-16 Warnings Exact identifier application number: M017 RelaxInk LIDOCAINE LIDOCAINE 4% Hambli Limited 49a1cf66-9bb1-b918-e063-6394a90a2ff6 2026-02-15 Warnings Exact identifier application number: M017 blue goo Pain Relieving MENTHOL 2.5% Garcoa, Inc. 7b9b5ac6-9568-464c-8096-0302a1e650df 2026-02-13 Warnings Exact identifier application number: M017 Methyl Salicylate 30 Percent Cream METHYL SALICYLATE Alexso, Inc 1d50ccb2-1a5d-49c7-8524-2f54eed63e85 2026-02-13 Warnings Exact identifier application number: M017 Antiseptic Mouth Rinse EUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOL Topco Associates LLC a38e91c1-7ac6-4a7f-a5a2-8d9166b1535a 2026-02-13 Warnings, Adverse reactions Exact identifier application number: M017 Gel Cooling Pain Relief MENTHOL Topco Associates LLC 80962394-a46f-48fd-8e0c-685dd1e500d7 2026-02-13 Warnings, Adverse reactions Exact identifier application number: M017 Banophen DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Major Pharmaceuticals 9758d886-bd58-4eb2-a827-fa8e7fee2b7c 2026-02-13 Warnings Exact identifier application number: M017 Natureplex Hydrocortisone Hydro HYDROCORTISONE Natureplex, LLC 2fc6a148-34bb-4289-8588-32c1bb011b98 2026-02-13 Warnings Exact identifier application number: M017 Capsaicin 0.035 Percent CAPSAICIN Alexso, Inc 6d0bc1cc-e812-4753-b20c-c0357dd6deb5 2026-02-13 Warnings Exact identifier application number: M017 Swiftalyn Numbing Cream LIDOCAINE 4% GENUINE INNOVATION LTD 3f74c4a6-26f0-ddf7-e063-6394a90a1225 2026-02-12 Warnings Exact identifier application number: M017 PHARMBANNER Arnica Bruise Cream ARNICA BRUISE CREAM Shenzhen Xinxin Yunhai Technology Co., Ltd. 3c783061-8e2d-8a84-e063-6394a90a5265 2026-02-12 Warnings Exact identifier application number: M017 ETERNAL SPIRIT BEAUTY PAIN RELIEF WITH HEMP MENTHOL, CAMPHOR Worldwide Cosmetics, Inc 459d64a9-0538-57c8-e063-6394a90a6155 2026-02-12 Warnings Exact identifier application number: M017 Antiseptic Mouth Rinse EUCALYPTOL Walgreen Co. cba60e9d-5f12-4c56-9fa5-6ce1514fc2b0 2026-02-12 Warnings, Adverse reactions Exact identifier application number: M017 Medicated Body Powder MENTHOL Walmart Stores Inc afd337b7-d76e-f17a-e053-2a95a90abac7 2026-02-12 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride 2% LIDOCAINE HYDROCHLORIDE Aldermed Inc. 4977b722-d08d-3d9e-e063-6294a90a9035 2026-02-12 Warnings Exact identifier application number: M017 Ice Gel ICE COLD ANALGESIC MENTHOL Jell Pharmaceuticals Pvt Ltd 4a8b3f84-8c45-eb94-e063-6394a90a3e73 2026-02-11 Warnings Exact identifier application number: M017 Walgreens Pain Relieving Lidocaine Patch LIDOCAINE Walgreen Co. 41c4e9fe-e407-b22a-e063-6394a90a4b27 2026-02-10 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE CREAM 1% Aldermed Inc. 4a7f2c0e-5cf3-29cb-e063-6394a90a5d8d 2026-02-10 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 80684-101-00 80684010100 74 mL in 1 BOTTLE (80684-101-00) 74 ml 2024-02-01 No No Current