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 51 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Certain Dri Clinical Strength Prescription Protection Rollon CERTAIN DRI CLINICAL STRENGTH PRESCRIPTION PROTECTION ROLLON Clarion Brands LLC 46a1f92e-4411-3989-e063-6394a90a7038 2025-12-23 Warnings Exact identifier application number: M017 PREMIERES PAIN MENTHOL Premiere Enterprises 128bd1e7-e961-416c-933b-fbd146e3d386 2025-12-23 Warnings Exact identifier application number: M017 PREMIERES PAIN MENTHOL Premiere Enterprises 35ff19df-4cc4-4fce-bd30-d87d835e0e26 2025-12-23 Warnings Exact identifier application number: M017 Premieres Pain MENTHOL Premiere Enterprises 1f081913-6106-4d06-a37a-631f710dbacb 2025-12-23 Warnings Exact identifier application number: M017 ABSORBINE jr. LIDOCAINE HCL, PHENOL Clarion Brands, LLC e1de73bb-917c-48d1-9a78-00c76edddb98 2025-12-23 Warnings Exact identifier application number: M017 ABSORBINE jr. PLUS Knee CAMPHOR, MENTHOL Clarion Brands, LLC 3ad8718d-ebf1-474f-8a91-48c78ab3b5c1 2025-12-23 Warnings Exact identifier application number: M017 Absorbine Jr. Plus MENTHOL Clarion Brands, LLC fd5d77fc-dc73-2aec-2c7f-0fca5d7d3a75 2025-12-23 Warnings Exact identifier application number: M017 ABSORBINE JR PLUS ULTRA STRENGTH PAIN MENTHOL Clarion Brands, LLC cf329707-d90a-29dd-f2c2-acfd5af614f3 2025-12-23 Warnings Exact identifier application number: M017 Absorbine Jr Pro Cream LIDOCAINE HCL, PHENOL Clarion Brands, LLC 17b3f1e6-5554-4f3e-b133-76ae8ffea919 2025-12-23 Warnings Exact identifier application number: M017 Absorbine Jr Pro No Mess Roll-on Plus LIDOCAINE HCL, PHENOL Clarion Brands, LLC a7172f17-1525-4738-b72c-92479c730af2 2025-12-23 Warnings Exact identifier application number: M017 ABSORBINE JR MENTHOL Clarion Brands, LLC d656e7f6-ca26-1873-6c11-08aa82091bb0 2025-12-23 Warnings Exact identifier application number: M017 Relief Recovery METHYL SALICYLATE Mayway Corporation 27afd45e-2dc5-d099-e063-6394a90ad2b7 2025-12-23 Warnings Exact identifier application number: M017 Mobility METHYL SALICYLATE Mayway Corporation 27af9d17-9c15-5e2a-e063-6394a90aeda5 2025-12-23 Warnings Exact identifier application number: M017 medlot pain relief gel patch LIDOCAINE Lotfancy, Inc. 3ce4af20-b227-5b98-e063-6394a90ab992 2025-12-23 Warnings Exact identifier application number: M017 Nizoral Scalp Itch Relief HYDROCORTISONE Kramer Laboratories dba59238-6beb-447e-8c4c-e4bc00fd2c20 2025-12-23 Warnings Exact identifier application number: M017 Salonpas LIDOCAINE Pain Relieving LIDOCAINE Hisamitsu America, Inc. 63911880-8194-4c7d-a72f-cab94761b2d7 2025-12-23 Warnings Exact identifier application number: M017 The Body Builders Cream MENTHOL Smart Cookie Solutions f803325e-eb86-4b9e-a401-0a91bdcd6389 2025-12-22 Warnings Exact identifier application number: M017 PROINNATE Numbing Cream LIDOCAINE,MENTHOL Guangdong Aimu Biological Technology Co., Ltd 46895ddb-0b9f-675e-e063-6394a90adf23 2025-12-22 Warnings Exact identifier application number: M017 Caring Mills Vaginal Anti-Itch Cream BENZOCAINE, RESORCINOL Veridian Healthcare f2362658-aea2-438e-a66c-738022e6e047 2025-12-22 Warnings Exact identifier application number: M017 HealthWise Pain Relieving Menthol Gel MENTHOL 2% Veridian Healthcare 396d0fd4-67be-4de1-8f0c-42c83dfe9120 2025-12-22 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