Chlorzoxazone

Overview

A centrally acting central muscle relaxant with sedative properties. It is claimed to inhibit muscle spasm by exerting an effect primarily at the level of the spinal cord and subcortical areas of the brain. (From Martindale, The Extra Pharmacopoea, 30th ed, p1202)

Indication

For the relief of discomfort associated with acute painful musculoskeletal conditions.

Associated Conditions

Acute painful musculoskeletal conditions

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Effectiveness of Chlorzoxazone Versus Orphenadrine Citrate in Alleviating Bruxism Pain	2025/08/07	NCT07109882	Not Applicable	Recruiting	University of Baghdad
Pharmacokinetic and Bioequivalence Comparison of Baclofen and Chlorzoxazone Administered Individually or Concurrently	2022/02/25	NCT05257447	Phase 1	Completed	University of Texas Southwestern Medical Center
A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers	2017/04/06	NCT03103568	Phase 1	Completed	Swedish Orphan Biovitrum
Chlorzoxazone in Hip and Knee Arthroplasty	2015/04/01	NCT02405104	Phase 4	Completed	Northern Orthopaedic Division, Denmark
The Effect of Chlorzoxazone on Moderate to Severe Postoperative Pain After Spine Surgery	2013/09/02	NCT01933542	Phase 4	Completed	Rigshospitalet, Denmark
Placebo-Controlled Cross Over Trial of Chlorzoxazone Intake	2011/04/27	NCT01342341	Phase 4	Completed	University of California, San Francisco
Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes	2010/08/24	NCT01187862	Phase 1	Completed	University Hospital, Basel, Switzerland

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Chlorzoxazone	Bryant Ranch Prepack	63629-9158	ORAL	500 mg in 1 1	3/26/2020
Chlorzoxazone	A-S Medication Solutions	50090-0315	ORAL	500 mg in 1 1	8/27/2019
CHLORZOXAZONE	Bryant Ranch Prepack	71335-2009	ORAL	500 mg in 1 1	5/25/2023
Chlorzoxazone	Dispensing Solutions, Inc.	55045-1594	ORAL	500 mg in 1 1	9/7/2011
CHLORZOXAZONE	Aurobindo Pharma Limited	59651-306	ORAL	500 mg in 1 1	9/5/2023
Chlorzoxazone	Actavis Pharma, Inc.	0591-2520	ORAL	500 mg in 1 1	8/25/2024
CHLORZOXAZONE	Aurobindo Pharma Limited	59651-305	ORAL	375 mg in 1 1	9/5/2023
Lorzone	Lake Erie Medical DBA Quality Care Products LLC	55700-517	ORAL	375 mg in 1 1	4/17/2017
Chlorzoxazone	Rebel Distributors Corp	21695-569	ORAL	500 mg in 1 1	11/3/2006
CHLORZOXAZONE	Rising Pharma Holdings, Inc.	16571-725	ORAL	375 mg in 1 1	6/9/2023

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
SOLAXIN TAB 200MG	N/A	EISAI (HONG KONG) COMPANY LIMITED	N/A	N/A	12/20/1988

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
ACETAZONE FORTE C8	teva canada limited	00834319	Tablet - Oral	250 MG	12/31/1991
GIN PAIN PILLS - TAB	Stella Pharmaceutical Canada Inc.	02212870	Tablet - Oral	250 MG	9/5/1996
BACK-AID FORTE - TAB	rougier pharma division of ratiopharm inc	02171287	Tablet - Oral	250 MG	12/31/1995
ACETAZONE FORTE	teva canada limited	00834300	Tablet - Oral	250 MG	12/31/1991
PARAFON FORTE	mcneil pharmaceutical, division of ortho-mcneil inc.	00132519	Tablet - Oral	250 MG	12/31/1949
PARAFON FORTE TABLETS	johnson & johnson - merck consumer pharmaceuticals of canada	02229946	Tablet - Oral	250 MG	5/30/1997
EXTRA STRENGTH TYLENOL ACHES AND STRAINS	mcneil consumer healthcare division of johnson & johnson inc	02155214	Tablet - Oral	250 MG	12/31/1996
PARAFON FORTE C8 W CODEINE TAB	mcneil pharmaceutical, division of ortho-mcneil inc.	00614920	Tablet - Oral	250 MG	12/31/1985

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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