Menthol

Overview

Menthol is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. Forming clear or white waxy, crystalline substance, menthol is typically solid at room temperature. (-)-Menthol is the naturally-occurring and main form of menthol, and is assigned the (1R,2S,5R) configuration. Menthol mediates anesthetic properties and anti-irritating properties locally, thus it is widely used to relieve minor throat irritations.

Indication

Used to treat occasional minor irritation, pain, sore mouth, and sore throat as well as cough associated with a cold or inhaled irritants.

Associated Conditions

Allergic Reaction
Back Pain Lower Back
Back pain
Chilblains
Common Cold
Contusions
Cough
Cough caused by Common Cold
Dandruff
Flu caused by Influenza
Generalised muscle aches
Haemorrhoids
Intercostal Pain
Itching caused by Dandruff
Itching of the scalp
Joint Pain
Mild pain
Muscle Strain
Muscle; Fatigue
Myalgia
Nasal Congestion
Oral Pain
Pain caused by Fracture Bone
Productive cough
Psoriasis
Redness of the scalp
Seborrheic Dermatitis
Shoulder Stiffness
Sore Throat
Sprains
Stiff Shoulder
Stiff neck
Swelling
Upper Respiratory Tract Infection
Articular inflammation
Hematomas
Muscle, joint pains
Nonspecific pain
Scalp irritation

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy of L-menthol on Breathlessness in Chronic Obstructive Pulmonary Disease	2023/06/05	NCT05888597	Phase 2	Recruiting	Region Skane
Antiperistaltic Effect and Safety of L-menthol in the Elderly With Contraindication to Buscopan	2020/10/20	NCT04593836	Phase 3	UNKNOWN	Taipei Veterans General Hospital, Taiwan
Study of NPO-13 During Colonoscopy	2019/09/20	NCT04097574	Phase 2	Completed	Nihon Pharmaceutical Co., Ltd
Desensitization of Nociceptive Afferents by Application of Topical Capsaicin, Trans-cinnamaldehyde and L-menthol	2017/04/27	NCT03132142	Not Applicable	UNKNOWN	Aalborg University
Phase Ⅱ Dose Response Study of NPO-13 in Patients Undergoing Total Colonoscopy	2014/10/16	NCT02265939	Phase 2	Completed	Nihon Pharmaceutical Co., Ltd

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
4% lidocaine plus 1% menthol Pain Relief Patch	Xuzhou Lanting Pharmaceutical Co., Ltd	85323-003	TOPICAL	1 g in 100 g	3/5/2025
5% Menthol Pain Relief Patch	Xuzhou Lanting Pharmaceutical Co., Ltd	85323-004	TOPICAL	5 g in 100 g	3/5/2025
MQ Pain Relieving Patch	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	83781-006	TOPICAL	5.7 g in 100 1	3/24/2025

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
ROWACHOL CAP E.C.	N/A	JACOBSON MEDICAL (HONG KONG) LIMITED	N/A	N/A	3/24/1984
CARECOMPLEX SOLUTION	N/A	BEST UNITED MARKETING LIMITED	N/A	N/A	1/17/2025
SALONPAS PAIN RELIEF PATCH LARGE PATCH	N/A	Hisamitsu Pharmaceutical (Hong Kong) Co., Limited	N/A	N/A	4/8/2025
OLBAS OIL	N/A	NGAISHING PHARMACEUTICAL TRADING (HK) LIMITED	N/A	N/A	8/3/1996
ROWATANAL CREAM	N/A	JACOBSON MEDICAL (HONG KONG) LIMITED	N/A	N/A	8/10/2022
COMFORTLINE SOLUTION	N/A	BEST UNITED MARKETING LIMITED	N/A	N/A	1/17/2025
NEO-ROWACHOL GASTRO-RESISTANT CAPSULES	N/A	JACOBSON MEDICAL (HONG KONG) LIMITED	N/A	N/A	5/4/2017

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BALMINIL NASAL OINTMENT	rougier pharma division of ratiopharm inc	02135639	Ointment - Nasal	4 MG / G	12/31/1995
TOKUHON MEDICATED PLASTER	eastland drug co. ltd.	02178478	Plaster - Topical	5.67 %	2/27/1998
SALONPAS - PLS TOP	Hisamitsu Pharmaceutical Co., Inc.	02179520	Plaster - Topical	5.7 %	8/3/1995
SALONPAS GEL-PATCH	Hisamitsu Pharmaceutical Co., Inc.	02238054	Plaster - Topical	1.00 G / 100 G	2/1/2002
STREPSILS EXTRA BLACK CHERRY	rb health (canada) inc.	02263998	Lozenge - Oral	4 MG	3/23/2007
NEW AMMELTZ	classical remedia ltd	02322714	Liquid - Topical	30 MG / ML	N/A
CEPACOL SENSATIONS SORE THROAT & BLOCKED NOSE	rb health (canada) inc.	02382881	Lozenge - Oral	8 MG	7/19/2012

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
SINUS INHALACIONES	Reckitt Benckiser Healthcare S.A.	41653	SOLUCIÓN PARA INHALACIÓN DEL VAPOR	Sin Receta	Not Commercialized
RADIO SALIL ANTIINFLAMATORIO CREMA	Laboratorios Vinas S.A.	50101	CREMA	Sin Receta	Commercialized
RUSCUS LLORENS POMADA RECTAL	Laboratorios Llorens S.L.	45946	POMADA RECTAL	Sin Receta	Commercialized
VASELINA MENTOLADA ORRAVAN 20 mg/g POMADA	Laboratorio Reig Jofre, S.A.	34412	POMADA	Sin Receta	Commercialized
LINIMENTO NAION SOLUCIÓN PARA PULVERIZACIÓN CUTÁNEA	Industrias Farmaceuticas Puerto Galiano S.A.	34157	LÍQUIDO CUTÁNEO	Sin Receta	Not Commercialized
PAZBRONQUIAL JARABE	Laboratorios Cinfa S.A.	38575	JARABE	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ICTIOMEN POLVO	Casen Recordati S.L.	48911	POLVO CUTÁNEO	Sin Receta	Not Commercialized
VAPORUB POMADA	Laboratorios Vicks S.L.	22051	POMADA	Sin Receta	Commercialized
CUCODOL 0,5 MG/2 MG/2 MG COMPRIMIDOS PARA CHUPAR	Pharmex Advanced Laboratories S.L.	45613	COMPRIMIDO PARA CHUPAR	Sin Receta	Not Commercialized
REFLEX FORTE GEL	Reckitt Benckiser Healthcare S.A.	59479	GEL	Sin Receta	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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