Is Carisoprodol approved by the US FDA?

Drugs@FDA lists 27 application product lines for Carisoprodol, including SOMA (Prescription); CARISOPRODOL (Prescription); CARISOPRODOL (Prescription); CARISOPRODOL (Prescription); CARISOPRODOL (Prescription).

Are there safety signals or safety updates for Carisoprodol?

US FDA: 1 entry (latest 2018-08-22).

Active substance

Carisoprodol

US FDA 27
US price lines 3
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
SOMA	350MG; 250MG	tablet · oral	MYLAN SPECIALITY LP	Prescription	9 Apr 1959
CARISOPRODOL	350MG	tablet · oral	WATSON LABS	Prescription	20 Apr 1982
CARISOPRODOL	350MG	tablet · oral	PHARMAZONE	Prescription	13 Apr 1989
CARISOPRODOL	350MG	tablet · oral	OXFORD PHARMS	Prescription	7 Mar 1997
CARISOPRODOL	350MG	tablet · oral	CHARTWELL RX	Prescription	8 Sep 1997
CARISOPRODOL	350MG	tablet · oral	ACCELRX LABS	Prescription	7 Jun 2005
CARISOPRODOL	350MG	tablet · oral	INGENUS PHARMS LLC	Prescription	22 Oct 2008
CARISOPRODOL	350MG; 250MG	tablet · oral	AUROBINDO PHARMA	Prescription	6 Aug 2009
CARISOPRODOL	350MG	tablet · oral	SCIEGEN PHARMS	Prescription	27 Jan 2014
CARISOPRODOL	350MG	tablet · oral	ORIENT PHARMA CO LTD	Prescription	27 Oct 2014
CARISOPRODOL	350MG	tablet · oral	NATCO	Prescription	28 Oct 2014
CARISOPRODOL	250MG; 350MG	tablet · oral	HERITAGE	Prescription	8 Jul 2015
CARISOPRODOL	250MG; 350MG	tablet · oral	MPP PHARMA	Prescription	11 May 2017
CARISOPRODOL	350MG	tablet · oral	POINTVIEW HLDINGS	Prescription	20 Oct 2021
SOMA	250MG	capsule · oral	MYLAN SPECIALITY LP	Discontinued	9 Apr 1959
CARISOPRODOL	350MG	tablet · oral	WATSON LABS TEVA	Discontinued	12 Jun 1979
CARISOPRODOL	350MG	tablet · oral	SUN PHARM INDUSTRIES	Discontinued	17 Oct 1991
CARISOPRODOL	350MG	tablet · oral	HIKMA INTL PHARMS	Discontinued	24 Jan 1996
CARISOPRODOL	350MG	tablet · oral	WATSON LABS	Discontinued	3 Dec 1996
CARISOPRODOL	350MG	tablet · oral	EPIC PHARMA LLC	Discontinued	21 Sep 2000
CARISOPRODOL	350MG	tablet · oral	ABLE	Discontinued	21 Jun 2001
CARISOPRODOL	350MG	tablet · oral	SUN PHARM INDS LTD	Discontinued	27 Feb 2007
CARISOPRODOL	250MG; 350MG	tablet · oral	STRIDES PHARMA	Discontinued	12 Nov 2015
CARISOPRODOL	350MG	tablet · oral	WATSON LABS	Discontinued
CARISOPRODOL	350MG	tablet · oral	PIONEER PHARMS	Discontinued

2 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CARISOPRODOL 250 MG TABLET	$0.47389	per EA	23 Sep 2026
US NADAC	CARISOPRODOL 350 MG TABLET	$0.07059	per EA	23 Sep 2026
US NADAC	SOMA 350 MG TABLET	$11.29746	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 22 Aug 2018 SOMA — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for carisoprodol →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.