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 145 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join INTIMALE Maximum Strength Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 25b9ade3-72b0-4b86-8c48-90310a26806f 2023-11-11 Warnings Exact identifier application number: M017 POWERECT Max Power Male Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 25a1c926-9543-44a7-865e-a4b6e1a40cbe 2023-11-11 Warnings Exact identifier application number: M017 SKINS DELAY Maximum Strength Lidocaine LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 172efe5d-28b8-443c-b3f9-429669189081 2023-11-11 Warnings Exact identifier application number: M017 GASPARI Ageless Pain Relief Cream MENTHOL GASPARI ANTI-AGING LLC ea806089-688b-4944-ad69-86f366509eb5 2023-11-11 Warnings Exact identifier application number: M017 ZENSEZONE Arthmed Temporary Pain Relief Cream CAPSAICIN, MENTHOL, METHYL SALICYLATE ZENSEZONE LLC c5778f22-c411-4bd7-b2af-45e3fee15fd2 2023-11-11 Warnings Exact identifier application number: M017 PRFC HEMP Topical Analgesic MENTHOL DOBEST INC 722da9d1-91d7-45be-adb1-8d6a22aa83ac 2023-11-11 Warnings Exact identifier application number: M017 AMP RELIEF Pain Relief Cream MENTHOL COASTAL FORMULAS LLC 84ea496e-ab54-4882-93ef-600f8eb33cb4 2023-11-11 Warnings Exact identifier application number: M017 AMP RELIEF Pain Relief Cream MENTHOL COASTAL FORMULAS LLC 39564c67-49ab-42d4-a391-792ac69180c0 2023-11-11 Warnings Exact identifier application number: M017 LIDOSOLVE PAIN RELIEF LIDOCAINE HYDROCHLORIDE HENNIKA HEALTH, LLC 3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e2 2023-11-11 Warnings Exact identifier application number: M017 AMINO ACTIVE Topical Analgesic Cream HISTAMINE DIHYDROCHLORIDE VIREO SYSTEMS, INC. 591b1e7e-a8c0-4640-a592-4e0f3538a40e 2023-11-11 Warnings Exact identifier application number: M017 NERVE ACTIVE Pain Relief Cream MENTHOL TOP DOG DIRECT, LLC a8b85dcb-fd3e-4340-a945-609fc741443c 2023-11-11 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back LIDOCAINE Geri-Gentle Corporation e4427928-c063-9ca6-e053-2995a90a1aa1 2023-11-10 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch Arm and Neck MENTHOL Geri-Gentle Corporation e4429f70-667e-662b-e053-2a95a90a62ba 2023-11-10 Warnings Exact identifier application number: M017 GeriGentle FrostyHeat Pain Relief Patch Back MENTHOL Geri-Gentle Corporation e442b8ec-a3de-65e8-e053-2995a90af3ec 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE STUFF Pain Relief MENTHOL BLUE SPRING WELLNESS, L.L.C. 9f948fb4-4275-4a1f-83f8-cd708db4a296 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE STUFF PAIN RELIEF MENTHOL BLUE SPRING WELLNESS, L.L.C. b4278b70-e9a6-4d1f-bbad-257fe437b86a 2023-11-10 Warnings Exact identifier application number: M017 BLUE SPRING Foot and Leg Comfort Cream with Pain Relief MENTHOL, CAPSAICIN BLUE SPRING WELLNESS, L.L.C. 2f9cf514-48be-49ec-b424-0b228b4b874a 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE STUFF Pain Relief MENTHOL BLUE SPRING WELLNESS, L.L.C. 1231ddd2-7661-45b2-ab15-32f7fdc078a8 2023-11-10 Warnings Exact identifier application number: M017 SUPER WHITE Stuff Pain Relief MENTHOL BLUE SPRING WELLNESS, L.L.C. 7779b26b-ae3b-4639-a6b0-826c7ab37a86 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE Theraplex Solutions a898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d4 2023-11-10 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