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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0a462c91-5300-e282-e063-6394a90a4cc2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

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 30 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RICHTOFIT RAPID ACTIVE ARTHRITIS	MENTHOL AND CAMPHOR	RICHTOFIT LIMITED LIABILITY COMPANY	4b1cdab1-3e50-4ec3-e063-6394a90af75e	2026-03-12	Warnings	Exact identifier application number: M017
5Kind DMSO 4 Lidocaine HCl Pain Relieving	LIDOCAINE HYDROCHLORIDE, MENTHOL	5KIND TRADING LTD	67d8d045-7fa0-46c2-8072-645d8823903b	2026-03-11	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4%	RAPID AID VIET NAM COMPANY LIMITED	4ca541b4-7afe-77c5-e063-6294a90ad692	2026-03-10	Warnings	Exact identifier application number: M017
Lidocaine Cream, 4%	LIDOCAINE	IPG PHARMACEUTICALS, INC.	7775bfdd-7eac-4f09-b83f-fc4a16a24558	2026-03-10	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	CHEMCO CORPORATION	4c989283-9a27-e8d2-e063-6294a90a8bfa	2026-03-09	Warnings	Exact identifier application number: M017
Prequel Anti-Itch Solution Medicated Calming	MEDICATED CALMING LOTION	The Center Brands, LLC	419fa45b-992b-676e-e063-6394a90add81	2026-03-09	Warnings	Exact identifier application number: M017
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	1fda69f7-2bb6-42fc-bcef-677e7b3d7f01	2026-03-09	Warnings	Exact identifier application number: M017
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for knee	MENTHOL, LAUROCAPRAM	Planet (Anhui) Pharmaceutical Co., Ltd.	7577625c-87eb-4639-aeab-8a2ab97033fd	2026-03-09	Warnings	Exact identifier application number: M017
Careland Lidocaine Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	7de99b81-b3b3-49f1-8aa7-2ff42e1b46a4	2026-03-09	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4%	RAPID AID VIET NAM COMPANY LIMITED	4ca35030-958c-8f62-e063-6294a90a4d63	2026-03-09	Warnings	Exact identifier application number: M017
Welmate Lidocaine Pain Relieving Patch	LIDOCAINE	YYBA Corp	cff71b75-fc4e-29ac-e053-2995a90abd50	2026-03-06	Warnings	Exact identifier application number: M017
Heal and Rescue Bunion Pain Relief	LIDOCAINE HCL, MENTHOL	Rooftop Consumer Health, Inc	4c60d4d3-e0a9-6f93-e063-6394a90a16af	2026-03-06	Warnings	Exact identifier application number: M017
JUST CBD - PAIN RELIEF	MENTHOL, CAMPHOR	Just Brands LLC	4c493c0b-c58e-cb56-e063-6394a90a9395	2026-03-05	Warnings	Exact identifier application number: M017
Hug a BooBoo Medicated booboo Wipes	BENZOCAINE	Lights Medical Manufacture Co., Ltd.	509aaafc-2ef7-4205-818c-7ff5b146e159	2026-03-04	Warnings	Exact identifier application number: M017
CVS Foot Pain	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	4c3350c3-2e3e-093c-e063-6394a90a3475	2026-03-04	Warnings	Exact identifier application number: M017
Game On Sport	MENTHOL	Natural Essentials, Inc	4c3411dc-5378-bd93-e063-6394a90a8406	2026-03-04	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	f4d4a56b-b4b7-9a07-e053-2a95a90ad853	2026-03-04	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	9987165c-1a0f-dd57-e053-2a95a90ae735	2026-03-04	Warnings	Exact identifier application number: M017
Walgreens Unscented Pain Relieving	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	Walgreen Co.	41eadb4f-2ca5-42a1-e063-6294a90ab4e2	2026-03-04	Warnings	Exact identifier application number: M017
Careland Pain Relief Patch Plus	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e3	2026-03-04	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
415974	menthol 4 % Topical Gel	PSN	0a462c91-5300-e282-e063-6394a90a4cc2	2
415974	menthol 0.04 MG/MG Topical Gel	SCD	0a462c91-5300-e282-e063-6394a90a4cc2	2
415974	menthol 4 % Topical Gel	SY	0a462c91-5300-e282-e063-6394a90a4cc2	2

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Thera Plus Cold Therapy Pain Relieving Gel Menthol	Fourstar Group USA, Inc.	2023-11-27	HUMAN OTC DRUG LABEL	2