Thera Plus Extra Strength Muscle Rub Topical Analgesic

Product NDC: 80684-139
11-digit product format: 806840139
Labeler code: 80684
Product ID: 80684-139_3c1ad278-b7b9-7859-e063-6294a90a528a
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: 2025-03-03
Substance: MENTHOL
Active strength: 25 mg/g
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 Extra Strength Muscle Rub Topical Analgesic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	25 mg/g

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
282805	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
8a3b6adf-afbb-4d77-a19b-a6514ebd3b50	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80684-139-00	Thera Plus Extra Strength Muscle Rub Topical Analgesic	42.5 g in 1 TUBE	GEL	42.5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80684-139	THERA PLUS EXTRA STRENGTH MUSCLE RUB TOPICAL ANALGESIC (MENTHOL) GEL [FOURSTAR GROUP USA, INC.]	2	Current NDC, 1 package rows	20250306_8a3b6adf-afbb-4d77-a19b-a6514ebd3b50.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 121 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Boil Ease	BENZOCAINE	Insight Pharmaceuticals LLC	bf108934-5e1a-4059-9dcf-008f52a83fab	2024-10-25	Warnings	Exact identifier application number: M017
Dermarest Eczema Medicated	HYDROCORTISONE	Insight Pharmaceuticals LLC	0292ab62-5088-45fa-a056-70c2fcc19ef7	2024-10-25	Warnings	Exact identifier application number: M017
anti itch	HYDROCORTISONE	Meijer, Inc.	2db7bcab-acb8-48ad-8cd1-842ff7765ed9	2024-10-23	Warnings	Exact identifier application number: M017
NATUREANCE MIRACLE	MENTHOL	EROS GLOBAL CORP	ec1a2a1f-a38d-9c59-e053-2a95a90ad268	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Plantar Relief Strips	CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE	Rooftop Consumer Health, Inc.	65e142d8-da21-4c55-9faf-b387cb6c2c0e	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Rooftop Consumer Health, Inc.	cc011b79-2761-40f7-8142-88f8e30a179a	2024-10-23	Warnings	Exact identifier application number: M017
Profoot Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Profoot, Inc.	06f82bde-41a1-35f6-e063-6394a90a6437	2024-10-23	Warnings	Exact identifier application number: M017
Deep Cover Bug Bite Relief	BENZOCAINE	Morrisons Outdoors, LLC	25010dd6-fb48-8ee7-e063-6394a90aee6c	2024-10-21	Warnings	Exact identifier application number: M017
Evel Knievels Natural Choice Pain Relief	MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	4576656c-4b6e-6965-7665-6c52756c6573	2024-10-21	Warnings	Exact identifier application number: M017
berkley and jensen anti itch	HYDROCORTISONE	BJWC	5cc6e4f6-c62d-4923-9726-9dbc569a3f49	2024-10-19	Warnings	Exact identifier application number: M017
DG Health Hydrocortisone Maximum Strength	HYDROCORTISONE	Dolgencorp Inc	2cc792b8-dce6-4178-bd6d-63ba268b7747	2024-10-19	Warnings	Exact identifier application number: M017
Careland Hydrogel Pain Relief Patches	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	e970070c-1c3b-49f0-8298-e6c5ebbf50a0	2024-10-18	Warnings	Exact identifier application number: M017
Fruit of the Earth Cool Blue Aloe Mist Continuous	LIDOCAINE HYDROCHLORIDE	Fruit Of The Earth, Inc.	d4caae4c-efba-2453-e053-2995a90a5e5f	2024-10-18	Warnings	Exact identifier application number: M017
CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving	LIDOCAINE HCL	CVS Pharmacy	f0f1969d-10e0-76ee-e053-2995a90a7336	2024-10-17	Warnings	Exact identifier application number: M017
Wong To Yick External Analgesic	CAMPHOR MENTHOL METHYL SALICYLATE	Wong To Yick Wood Lock Ointment Ltd	16a21af4-6bc0-4ae1-aa3b-1da84c8286e2	2024-10-17	Warnings	Exact identifier application number: M017
Wong To Yick External Analgesic	CAMPHOR MENTHOL METHYL SALICYLATE	Wicsun Trading Inc	0b4bd444-b3c1-47aa-a7e3-f16c92326124	2024-10-17	Warnings	Exact identifier application number: M017
Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL	LIDOCAINE	Fruit of the Earth, Inc.	c7a833bd-7457-73a3-e053-2a95a90ac53f	2024-10-17	Warnings	Exact identifier application number: M017
Wegmans Aloe After Sun Gel with Lidocaine HCl External Analgesic	LIDOCAINE HYDROCHLORIDE	WEGMANS FOOD MARKETS INC	f70bc438-7ed8-f74d-e053-6394a90a2b3f	2024-10-16	Warnings	Exact identifier application number: M017
EQUATE Sunburn relief with Aloe After Sun	LIDOCAINE	Wal-Mart Stores Inc	c25e1288-7ac6-41fc-ab65-26c379f288a7	2024-10-16	Warnings	Exact identifier application number: M017
Genuine First Aid Insect Sting Relief Pad 1 ct	BENZOCAINE, ALCOHOL	GFA Production (Xiamen) Co., Ltd.	b119ba37-0ee1-851a-e053-2995a90a85b1	2024-10-15	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
282805	menthol 2.5 % Topical Gel	PSN	8a3b6adf-afbb-4d77-a19b-a6514ebd3b50	3
282805	menthol 0.025 MG/MG Topical Gel	SCD	8a3b6adf-afbb-4d77-a19b-a6514ebd3b50	3
282805	menthol 2.5 % Topical Gel	SY	8a3b6adf-afbb-4d77-a19b-a6514ebd3b50	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80684-139-00	80684013900	42.5 g in 1 TUBE (80684-139-00)	42.5 g	2025-03-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Thera Plus Extra Strength Muscle Rub Topical Analgesic Gel	FOURSTAR GROUP USA, INC.	2025-08-11	HUMAN OTC DRUG LABEL	3