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 12 of 156 · 3,115 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AVON Foot Works Arthritis Achy Foot and Muscle METHYL SALICYLATE COSMAX USA, CORPORATION 56440d3f-bc93-cebb-e063-6294a90a5f79 2026-07-10 Warnings Exact identifier application number: M017 CHEONG KUN PAIN RELIEVING CAMPHOR CHEONG KUN PAIN RELIEVER OIL CHINESE MEDICINE FACTORY (MACAU) LIMITED 557d5cb3-2a05-4f45-e063-6394a90a9b12 2026-07-10 Warnings Exact identifier application number: M017 Biofreeze Professional MENTHOL Reckitt Benckiser LLC 485c8208-c93b-5b84-e063-6394a90ab77a 2026-07-10 Warnings Exact identifier application number: M017 Fit Mist Pain Relief MENTHOL Aroma Sensations Inc f5a98544-8bd7-42dc-a594-5559e3920e29 2026-07-09 Warnings Exact identifier application number: M017 Nuturna Sciatica MENTHOL Micelle Laboratories, Incorporated ff200864-bedf-4138-bdec-2b23701406dd 2026-07-09 Warnings Exact identifier application number: M017 Lidocaine cream DRS LIDOCAINE 5% CREAM OL PHARMA TECH LLC. (Drs. Pharmacy) 372fe018-1e5a-9ec4-e063-6294a90a1500 2026-07-09 Warnings Exact identifier application number: M017 Nupharmisto 4% Lidocaine Numbing cream LIDOCAINE 4% EveryMarket Inc 5615e49d-e03b-f915-e063-6294a90a1786 2026-07-08 Warnings Exact identifier application number: M017 CAREALL Musle and Joint MENTHOL New World Imports, Inc 561cc103-ae88-8f30-e063-6294a90a05c4 2026-07-08 Warnings Exact identifier application number: M017 HealthWise Medicated Cold Hot MENTHOL Veridian Healthcare, LLC 561e1409-d1d8-e35d-e063-6394a90a4d8f 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Balm Roll On Pain Relief MENTHOL WB Ventures LLC 3b1834e6-75cd-5380-e063-6294a90ad1d5 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Balm Itch Relief Cream MENTHOL WB Ventures LLC 0ce31b5d-4401-460c-e063-6394a90ab558 2026-07-08 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc. 560a4abf-31dd-333f-e063-6294a90a3505 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Balm MENTHOL WB VENTURES LLC b9f50c43-b0d5-39a8-e053-2995a90a04f1 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Bug Bite Balm MENTHOL WB Ventures LLC b9fab18f-32c7-d5bd-e053-2995a90a6d0f 2026-07-08 Warnings Exact identifier application number: M017 Salonpas pain relieving hot CAPSAICIN, MENTHOL Hisamitsu Pharmaceutical Co., Inc. d2aa8820-a947-404b-b617-e692fbd16502 2026-07-07 Warnings Exact identifier application number: M017 Quali Yi Tiao Gen Pain Patch CAPSAICIN PATCH Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory 33154a9b-f6d0-4e95-b4cb-6b938f5dcf4d 2026-07-07 Warnings Exact identifier application number: M017 DIPROSPAN HYDROCORTISONE OPMX LLC 55fa9ecb-b843-5748-e063-6294a90a2d53 2026-07-06 Warnings Exact identifier application number: M017 MUYOHON Numbing Cream NUMBING CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 55caf0a5-f062-a6c3-e063-6294a90ae073 2026-07-04 Warnings Exact identifier application number: M017 Targeted Warming Capsaicin Patch CAPSAICIN Army & Air Force Exchange Service 55b539f8-38c4-594e-e063-6394a90afbaa 2026-07-03 Warnings Exact identifier application number: M017 TopCare Health Pain Relief LIDOCAINE HYDROCHLORIDE Topco Associates LLC 485b0671-da09-19d7-e063-6294a90aca5d 2026-07-03 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