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 83 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Good Neighbor Roll-on Pain Relief LIDOCAINE HCL Amerisource Bergen a0c3adbf-fa35-47c0-9db3-459ce9a106ac 2025-08-06 Warnings Exact identifier application number: M017 Good Neighbor Roll-on Menthol Pain Relief Gel MENTHOL Amerisource Bergen bd557323-0003-4ee6-b22d-a72d621c7de4 2025-08-05 Warnings Exact identifier application number: M017 Earthmed FS Pain relieving balm MENTHOL Earthmed LLC 3ba4e769-fec6-52d9-e063-6394a90a65d4 2025-08-05 Warnings Exact identifier application number: M017 HYDROCORTISONE HYDROCORTISONE HF Acquisition Co LLC, DBA HealthFirst 3ba6a5ec-fda2-b2a6-e063-6294a90ac9b6 2025-08-05 Warnings Exact identifier application number: M017 Kocowo Lidocaine Pain Relief Gel-Patch LIDOCAINE PAIN RELIEF GEL-PATCH Henan Enokon Medical Instrument Co., Ltd. 3b82989d-7cc3-23d3-e063-6294a90ae2a3 2025-08-03 Warnings Exact identifier application number: M017 Menthol pain relief patches MENTHOL Menthol pain relief patch 3b5fd718-3f86-f7a7-e063-6294a90a8c52 2025-08-02 Warnings Exact identifier application number: M017 Graphene Far Infrared Herbal Pain Relief Patches CORYDALIS RHIZOME Changsha Maocheng Trading Co., Ltd 3b604a3c-fe91-7096-e063-6394a90afe04 2025-08-02 Warnings Exact identifier application number: M017 Active Recovery Pain Relief CAMPHOR, MENTHOL Charlotte's Web, Inc. 3a9f9ca0-3d8a-796a-e063-6394a90a790c 2025-08-01 Warnings Exact identifier application number: M017 Active Recovery Pain Relief Stick CAMPHOR, MENTHOL Charlottes Web, Inc. 3aa037c6-6109-b52e-e063-6394a90a215b 2025-08-01 Warnings Exact identifier application number: M017 PM Recovery Pain Relief CAMPHOR, MENTHOL Charlotte's Web, Inc. 3aa08859-809d-de8c-e063-6394a90a8e25 2025-08-01 Warnings Exact identifier application number: M017 Wish ultra winter ice MENTHOL LJ Pharma b4c5487c-1314-4d63-96df-077e72e7ee95 2025-08-01 Warnings Exact identifier application number: M017 Rugged Fit Pain Relief Roll On MENTHOL, METHYL SALICYLATE SYSTEM4BOOK LLC 39d68734-981c-14d7-e063-6294a90a4919 2025-08-01 Warnings Exact identifier application number: M017 ICY FREEZE MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 28fdb049-b297-4358-9447-7d69ba879702 2025-08-01 Warnings Exact identifier application number: M017 Cortizone 10 Cooling HYDROCORTISONE Chattem, Inc. 14d9fce2-9f54-4204-83cb-161de8a303f0 2025-08-01 Warnings Exact identifier application number: M017 Bravado Labs Numbing LIDOCAINE HCL Prodigy Media Inc 8c43f5b5-b911-4a7a-b2d1-56a09c54b001 2025-07-30 Warnings Exact identifier application number: M017 Chimera GUARD LIDOCAINE PAIN RELIEFING PATCH Hangzhou Rongna Health Technology Co., Ltd. 3721c984-1993-6265-e063-6394a90af23f 2025-07-29 Warnings Exact identifier application number: M017 Chimera GUARD LIDOCAINE PAIN RELIEFING PATCH Hangzhou Rongna Health Technology Co., Ltd. 3758d625-010f-7441-e063-6394a90a066d 2025-07-29 Warnings Exact identifier application number: M017 Cold Therapy Roll on COLD THERAPY ROLL ON Allegiant Health 36463acb-7c28-416f-a45f-a93f0be5692b 2025-07-29 Warnings Exact identifier application number: M017 ProCure Anti Itch CAMPHOR 0.5% Twin Med LLC 3afe387c-ef42-215d-e063-6394a90a41b5 2025-07-28 Warnings Exact identifier application number: M017 lidocaine pain relief patches LIDOCAINE Changsha Maocheng Trading Co., Ltd 3afeead3-4f5c-4711-e063-6294a90aacca 2025-07-28 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