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 17 of 156 · 3,115 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sting Relief Prep Pad BENZOCAINE NINGBO TIANBO FIRST AID PRODUCT CO., LTD. 9487d15d-9116-4ff8-a004-ba0835ea091e 2026-05-31 Warnings Exact identifier application number: M017 Careland Kinesiology Pain Relieving Tape CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE Planet (Anhui) Pharmaceutical Co., Ltd. 35d24cfc-9d34-4fd7-9312-1673b092a3b9 2026-05-31 Warnings Exact identifier application number: M017 Walgreens Scalp Itch Relief HYDROCORTISONE Walgreens 34952272-1f9e-c642-e063-6394a90ae2bd 2026-05-29 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine No-Mess Applicator LIDOCAINE HYDROCHLORIDE Chattem, Inc. 8092cde7-28d0-4755-b5c0-5765934e572f 2026-05-29 Warnings Exact identifier application number: M017 Belladona and Arnica MENTHOL Dannso Corp./d.b.a. Essential Products fc4e63e4-cebc-49ff-8900-7238261d0fe0 2026-05-28 Warnings Exact identifier application number: M017 Insect Sting Relief BENZOCAINE, ALCOHOL Hubei Fanjian Medical Product Co.,Ltd f30401c1-961e-44dd-e053-2a95a90a69d6 2026-05-28 Warnings Exact identifier application number: M017 Menthol plus Camphor Pain Relief MENTHOL, CAMPHOR Veridian Healthcare 4a054949-0889-7182-e063-6394a90aff5e 2026-05-28 Warnings Exact identifier application number: M017 Antibacterial Lidocaine Wound Gel BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE CVS Pharmacy 960bfe55-87f6-3e51-e053-2995a90a867d 2026-05-27 Warnings Exact identifier application number: M017 MyDerm Medical 5 Lidocaine Numbing Roll-On LIDOCAINE Inspec Solutions 1d466be1-a780-462f-8dd4-87478da096aa 2026-05-27 Warnings Exact identifier application number: M017 myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol MENTHOL Inspec Solutions LLC. d427d623-c2fd-7d6b-e053-2995a90abdc3 2026-05-27 Warnings Exact identifier application number: M017 Caldyphen Clear PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE Amerisource Bergen d8802e56-649e-4494-86ee-7ca8841cc28b 2026-05-27 Warnings Exact identifier application number: M017 Equate Itch Relief Gel ITCH RELIEF GEL Walmart, Inc 7d7bb750-017e-c60e-e053-2991aa0ad671 2026-05-26 Warnings Exact identifier application number: M017 MyDerm Bite and Sting BENZOCAINE Medline Industries bf45c4dd-5814-4602-b96b-f82a44948763 2026-05-26 Warnings Exact identifier application number: M017 MyDerm Aloe and Lidocaine LIDOCAINE Medline Industries fdfd4388-cd27-467b-959b-249a49ea5cf6 2026-05-26 Warnings Exact identifier application number: M017 MyDerm Aloe and Lidocaine LIDOCAINE Inspec Solutions LLC. 4939c663-a876-4527-822a-df02964fa694 2026-05-26 Warnings Exact identifier application number: M017 Lidocaine Menthol Pain Relief LIDOCAINE, MENTHOL Amerisource Bergen 94039190-dde3-4d8e-873a-79abd3f6208b 2026-05-26 Warnings Exact identifier application number: M017 Vicks VapoFreeze PAIN RELIEF CAMPHOR, MENTHOL The Procter & Gamble Manufacturing Company 526cdb40-aa65-4885-e063-6294a90afa0c 2026-05-22 Warnings Exact identifier application number: M017 topcare hydrocortisone HYDROCORTISONE Topco Associates LLC 858053a0-d888-4bb9-b94e-503bcf3864cb 2026-05-21 Warnings Exact identifier application number: M017 Arthritis Pain Relief Cream HISTAMINE DIHYDROCHLORIDE Sombra Cosmetics Inc. 523333ee-eccd-bcf7-e063-6394a90aea60 2026-05-21 Warnings Exact identifier application number: M017 North Star Nutritionals Soothanol X3 Pain Relieving Drops MENTHOL NEWMARKET HEALTH PRODUCTS, LLC 068343b8-0435-40d0-846c-9d8624e8b6c4 2026-05-21 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