Methyl salicylate

Overview

Methyl salicylate (oil of wintergreen or wintergreen oil) is an organic ester naturally produced by many species of plants, particularly wintergreens. The compound was first extracted and isolated from plant species Gaultheria procumbens in 1843. It can be manufactured synthetically and it used as a fragrance, in foods, beverages, and liniments. It forms a colorless to yellow or reddish liquid and exhibits a characteristic odor and taste of wintergreen. For acute joint and muscular pain, methyl salicylate is used as a rubefacient and analgesic in deep heating liniments. It is used as a flavoring agent in chewing gums and mints in small concentrations and added as antiseptic in mouthwash solutions.

Indication

Ointments or liniments containing methyl salicylate are applied topically as counter irritant for relief of acute pain associated with lumbago,sciatica and rheumatic conditions. Local analgesics for human and veterinary medicine.

Associated Conditions

Acute Muscle Pain
Back Pain Lower Back
Back pain
Bone pain
Contusions
Joint Pain
Ligament pain
Muscle Inflammation
Muscle Injuries
Muscle Strain
Muscle swelling
Myalgia
Neuropathic Pain
Pain
Partial-Onset Seizures
Postherpetic Neuralgia
Sprains
Tendon pain
Articular inflammation
Minor aches
Muscle, joint pains

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Clinical Efficacy and Safety of Compound Methyl Salicylate Liniment	2017/12/05	NCT03362216	Not Applicable	Completed	Peking University People's Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
RockSauce Warming Massage	Nantong Health & Beyond Hygienic Products Inc.	43473-076	TOPICAL	200 mg in 1 mL	5/27/2025
Medrox-Rx	Pharmaceutica North America, Inc.	45861-005	TOPICAL	24 g in 120 g	10/27/2011
Major Arthritis Pain Relief Patch	Major Pharmaceuticals	0904-7342	TOPICAL	10 g in 100 g	9/2/2025
Antispetic	Big Lots	50594-664	ORAL	0.6 mg in 1 mL	5/7/2025
Methyl Salicylate 10%	ViolaCare, Inc.	85231-101	TOPICAL	10 g in 100 g	6/7/2025
Rugged Fit Pain Relief Roll On	SYSTEM4BOOK LLC	85826-041	TOPICAL	10 g in 100 mL	8/1/2025
Antispetic	Target Corporation	11673-664	ORAL	0.6 mg in 1 mL	5/7/2025
Tartar control plus Antiseptic	TopCo Associates LLC	76162-855	ORAL	0.6 mg in 1 mL	5/7/2025
Antiseptic Mouthrinse	Lidl US, LLC	71141-155	ORAL	0.6 mg in 1 mL	3/24/2025
Antiseptic Mouth Rinse	HARRIS TEETER	72036-072	ORAL	0.6 mg in 1 mL	3/3/2025

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
ROBINSON RINGWORM AND WHITESPOT LOTION	BEACONS PHARMACEUTICALS PTE LTD	SIN08677P	LOTION	0.95%	4/24/1996

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
SALIRUB OINTMENT	N/A	MARCHING PHARMACEUTICAL LIMITED	N/A	N/A	3/11/2006
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
EUGENPAS PATCH	N/A	EUGENPHARM INTERNATIONAL LIMITED	N/A	N/A	5/3/2010
SINSINPAS PATCH	N/A	EUGENPHARM INTERNATIONAL LIMITED	N/A	N/A	5/3/2010
FORTOHOT PATCH	N/A	FP HEALTHCARE LIMITED	N/A	N/A	1/9/2025
PAINKILL LOTION	N/A	EUGENPHARM INTERNATIONAL LIMITED	N/A	N/A	7/9/2010
OLBAS OIL	N/A	NGAISHING PHARMACEUTICAL TRADING (HK) LIMITED	N/A	N/A	8/3/1996
ZENOL GEL STICK	N/A	RS Lifestyle Limited	N/A	N/A	12/22/2008
AMMEL LOTION	N/A	EUGENPHARM INTERNATIONAL LIMITED	N/A	N/A	7/9/2010

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
GOLD CROSS MUSCLE RUB CREAM jar	13916	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	9/5/1991
ATHELITE LAVA JOINT & MUSCLE PAIN RELIEF CREAM	429411	Twisobell Health Pty Ltd	Medicine	A	12/1/2023
Deep Heat Game Day Original Heat Rub	478626	Mentholatum Australasia Pty Ltd	Medicine	A	2/12/2025
Deep Heat Pain Relief Spray	468608	Mentholatum Australasia Pty Ltd	Medicine	A	11/14/2024
METHYL SALICYLATE OINTMENT jar/can	14713	Care Essentials PharmAust Pty Ltd	Medicine	A	10/25/1991
ATHELITE LAVA ICE JOINT & MUSCLE PAIN RELIEF SPRAY	428839	Twisobell Health Pty Ltd	Medicine	A	11/28/2023
GOANNA OIL LINIMENT Metal Can Liniment	18164	Lupin Australia Pty Limited	Medicine	A	9/26/1991
GOLD CROSS MUSCLE RUB OINTMENT methyl salicylate jar	14287	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	8/30/1991
THARS Ointment	17149	Sutcliffe Labs Pty Ltd	Medicine	A	9/30/1991
WHITE FLOWER EMBROCATION Liniment	19130	Shen Neng Herbal Medicines Group Pty Ltd	Medicine	A	9/30/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
WINTERGREEN OIL OF	stanley pharmaceuticals, a division of vita health products inc.	00178624	Liquid - Topical	null NIL / NIL	12/31/1972
GAULTHERIA PROCUMBENS	dolisos canada inc.	02234499	Liquid , Globules , Granules - Oral	1 X	1/5/1998
CHAMOMILLA SIMILIAPLEX	sisu inc.	02231874	Liquid - Oral	3 D	5/30/1998
CARBOSEPTOL	herbes universelles inc.	00361593	Ointment - Topical	13.3 MG / G	12/31/1966
WATKINS ANALGESIC BALM	watkins incorporated	00376450	Cream - Topical	7 %	12/31/1977
RUBBEX CREME	vitalab	00840815	Cream - Topical	15 %	12/31/1994
ARTHRICARE PAIN RELIEVING RUB TRIPLE MEDICATED GEL	del pharmaceuticals inc.	01935054	Gel - Topical	30 %	12/31/1991
ARTHRITIS PAIN RELIEVER HERBALIFE	herbalife international of america, inc.	00578711	Liquid - Topical	1 %	12/31/1983
MEDICATED ANALGESIC CREAM	prodemdis enr.	02038196	Cream - Topical	12.5 %	10/25/1996
CARMATIS ONT	carmaran ltée	00478512	Ointment - Topical	10 %	12/31/1981

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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