Regulatory PathRegulatory requirements compared

Active substance

Naproxen

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ALEVE 220 mg film-coated tablet220 mgFilm-coated tablet · Oral use12 BlisterSAR 11.65NCE · OTCBAYER CONSUMER CARE AGValid
NAPROTEX 500 mg tablet500 mgTablet · Oral use10 BlisterSAR 18.90Generic · OTCAPOTEXValid
NAPROX 250MG TAB250 mgTablet · Oral use20 BlisterSAR 17.25Generic · OTCHikma Pharmaceuticals PLCValid
NAPROX D.S 500MG TAB500 mgTablet · Oral use10 BlisterSAR 14.95Generic · OTCHikma Pharmaceuticals PLCValid
PROXEN F.C TAB 500MG500 mgFilm-coated tablet · Oral use20 BlisterSAR 35.30Generic · OTCSTADA ARZNEIMITTEL GmbHValid
PROXEN F.C. TAB 250MG250 mgFilm-coated tablet · Oral use20 BlisterSAR 26.35NCE · OTCSTADA ARZNEIMITTEL GmbHValid
MIRANAX 550 MG F- C TABLETS550 mgFilm-coated tablet · Oral use10 BlisterSAR 20.15Generic · OTCGRUNENTHALWithdrawn by MAH · Not Marketed
NAPROTEX 250MG-TAB.250 mgTablet · Oral use20 BlisterSAR 20.55Generic · OTCAPOTEXWithdrawn by MAH · Not Marketed
PROXEN F.C TAB 500MG500 mgFilm-coated tablet · Oral use20 BlisterSAR 44.15Generic · OTCGRUNENTHALWithdrawn by MAH · Not Marketed
PROXEN F.C. TAB 250MG250 mgFilm-coated tablet · Oral use20 BlisterSAR 33.00NCE · OTCGRUNENTHALWithdrawn by MAH · Not Marketed
PROXEPAIN220 mgFilm-coated tablet · Oral use20 BlisterSAR 19.45Generic · OTCRIYADH PHARMAWithdrawn by MAH · Not Marketed
PROXEPAIN220 mgFilm-coated tablet · Oral use10 BlisterSAR 11.05Generic · OTCRIYADH PHARMAWithdrawn by MAH · Not Marketed
RIAPROXEN 250 mg film-coated tablet250 mgFilm-coated tablet · Oral use20 BlisterSAR 22.45Generic · OTCRIYADH PHARMAWithdrawn by MAH · Not Marketed
RIAPROXEN 500 mg film-coated tablet500 mgFilm-coated tablet · Oral use20 BlisterSAR 28.35Generic · OTCRIYADH PHARMAWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACUTE COUGH; ACUTE PANCREATITIS-PAIN MANAGEMENT; ANKYLOSING SPONDYLITIS; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; CHRONIC PANCREATITIS; ENDOMETRIOSIS; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; EPIDERMOLYSIS BULLOSA; GOUT; INFECTIOUS MONONUCLEOSIS; JUVENILE IDIOPATHIC ARTHRITIS (JIA); LOW BACK PAIN; MENSTRUAL DISORDERS; MIGRAINE/ HEADACHE; MUCOSAL ULCERATION-SUPPORTIVE AGENTS; NECROTIZING PERIODONTITIS AND NECROTIZING ULCERATIVE GINGIVITIS; NON-INFECTIOUS UVEITIS; OSTEOARTHRITIS; PAIN MANAGEMENT IN CANCER PATIENTS; PERICORONITIS; PHARYNGITIS; POLYCYTHEMIA VERA - BONE PAIN; POSTOPERATIVE PAIN; PSORIATIC ARTHRITIS; RENAL AND URETERIC STONES; RHEUMATOID ARITHRITIS; SICKLE CELL DISEASE - PAIN MANAGEMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
NAPROSYN500MGtablet · oralATNAHS PHARMA USPrescription11 Mar 1976
ANAPROX DSEQ 500MG BASEtablet · oralATNAHS PHARMA USPrescription4 Sep 1980
NAPROSYN25MG/MLsuspension · oralATNAHS PHARMA USPrescription23 Mar 1987
NAPROXEN250MG; 375MG; 500MGtablet · oralGRANULESPrescription21 Dec 1993
NAPROXEN250MG; 375MG; 500MGtablet · oralTEVAPrescription21 Dec 1993
ALEVE220MGtablet · oralBAYEROver-the-counter11 Jan 1994
NAPROXEN25MG/MLsuspension · oralHIKMA PHARMSPrescription30 Mar 1994
EC-NAPROSYN375MG; 500MGtablet, delayed release · oralATNAHS PHARMA USPrescription14 Oct 1994
NAPRELANEQ 375MG BASE; EQ 500MG BASE; EQ 750MG BASEtablet, extended release · oralTWI PHARMSPrescription5 Jan 1996
NAPROXEN SODIUM220MGtablet · oralCONTRACT PHARMACALOver-the-counter13 Jan 1997
NAPROXEN SODIUM220MGtablet · oralPERRIGOOver-the-counter13 Jan 1997
NAPROXEN375MG; 500MGtablet, delayed release · oralTEVAPrescription30 Jun 1998
NAPROXEN SODIUM220MGtablet · oralDR REDDYS LABS INCOver-the-counter28 Jul 1998
NAPROXEN375MG; 500MGtablet, delayed release · oralAUROBINDO PHARMA USAPrescription19 Apr 2001
NAPROXEN250MG; 375MG; 500MGtablet · oralAMNEAL PHARMS NYPrescription18 Dec 2001
NAPROXEN SODIUMEQ 500MG BASE; EQ 375MG BASE; EQ 750MG BASEtablet, extended release · oralACTAVIS LABS FL INCPrescription27 Aug 2002
NAPROXEN SODIUMEQ 200MG BASEcapsule · oralBIONPHARMAOver-the-counter17 Feb 2006
NAPROXEN250MG; 375MG; 500MGtablet · oralGLENMARK PHARMS LTDPrescription28 Mar 2007
NAPROXEN SODIUMEQ 250MG BASE; EQ 500MG BASEtablet · oralGLENMARK PHARMS LTDPrescription27 Apr 2007
NAPROXEN250MG; 375MG; 500MGtablet · oralZYDUS PHARMS USAPrescription7 Jun 2007
NAPROXEN SODIUMEQ 250MG BASE; EQ 500MG BASEtablet · oralDR REDDYS LABS LTDPrescription26 Jul 2007
NAPROXEN SODIUM220MGtablet · oralAMNEAL PHARMS NYOver-the-counter16 Dec 2008
NAPROXEN250MG; 375MG; 500MGtablet · oralMARKSANS PHARMAPrescription14 Feb 2011
NAPROXEN SODIUM220MGtablet · oralMARKSANS PHARMAOver-the-counter16 Mar 2011
NAPROXEN375MG; 500MGtablet, delayed release · oralNUVO PHARMS INCPrescription19 Sep 2011

60 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ALEVE BACK AND BODY PAIN02436337220 MGCAPSULE · ORALBAYER INC
ALEVE CAPLETS02301733220 MGTABLET · ORALBAYER INC
ALEVE LIQUID GELS02361795220 MGCAPSULE · ORALBAYER INC
ANAPROX02162725275 MGTABLET · ORALSEARCHLIGHT PHARMA INC
ANAPROX DS02162717550 MGTABLET · ORALSEARCHLIGHT PHARMA INC
APO-NAPRO-NA00784354275 MGTABLET · ORALAPOTEX INC
APO-NAPRO-NA DS01940309550 MGTABLET · ORALAPOTEX INC
APO-NAPROXEN00522651250 MGTABLET · ORALAPOTEX INC
APO-NAPROXEN00592277500 MGTABLET · ORALAPOTEX INC
APO-NAPROXEN00600806375 MGTABLET · ORALAPOTEX INC
APO-NAPROXEN EC02246700375 MGTABLET (ENTERIC-COATED) · ORALAPOTEX INC
APO-NAPROXEN EC02246701500 MGTABLET (ENTERIC-COATED) · ORALAPOTEX INC
APO-NAPROXEN EC TABLETS02246699250 MGTABLET (ENTERIC-COATED) · ORALAPOTEX INC
MAXIDOL LIQUID GELS02372991220 MGCAPSULE · ORALBAYER INC
NAPROSYN02162423500 MGTABLET (DELAYED-RELEASE) · ORALSEARCHLIGHT PHARMA INC
NAPROSYN02162466750 MGTABLET (EXTENDED-RELEASE) · ORALSEARCHLIGHT PHARMA INC
NAPROXEN02362430220 MGTABLET · ORALPHARMASCIENCE INC
NAPROXEN MENSTRUAL PAIN RELIEF02396009220 MGTABLET · ORALPHARMASCIENCE INC
NAPROXEN-NA00887056275 MGTABLET · ORALPRO DOC LIMITEE
NAPROXEN-NA DF02153386550 MGTABLET · ORALPRO DOC LIMITEE
PEDIAPHARM NAPROXEN SUSPENSION0216243125 MG / MLSUSPENSION · ORALMEDEXUS PHARMACEUTICALS INC.
PRO-NAPROXEN EC02310953500 MGTABLET (DELAYED-RELEASE) · ORALPRO DOC LIMITEE
TEVA-NAPROXEN00565350250 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-NAPROXEN00589861500 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-NAPROXEN00627097375 MGTABLET · ORALTEVA CANADA LIMITED

5 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFT NAPROXEN SODIUM 220 MG CAP$0.14941per EA23 Sep 2026
US NADACGNP NAPROXEN SOD 220 MG CAPLET$0.06732per EA23 Sep 2026
US NADACGNP NAPROXEN SOD 220 MG TABLET$0.06732per EA23 Sep 2026
US NADACGNP NAPROXEN SODIUM 220 MG CAP$0.14941per EA23 Sep 2026
US NADACGS NAPROXEN SOD 220 MG CAPLET$0.06732per EA23 Sep 2026
US NADACGS NAPROXEN SOD 220 MG TABLET$0.06732per EA23 Sep 2026
US NADACNAPROXEN 125 MG/5 ML SUSPEN$0.20183per ML23 Sep 2026
US NADACNAPROXEN 125 MG/5 ML SUSPEN$0.12157per ML23 Sep 2026
US NADACNAPROXEN 250 MG TABLET$0.04356per EA23 Sep 2026
US NADACNAPROXEN 375 MG TABLET$0.05884per EA23 Sep 2026
US NADACNAPROXEN 500 MG TABLET$0.05654per EA23 Sep 2026
US NADACNAPROXEN DR 375 MG TABLET$2.23429per EA30 Sep 2026
NHS Drug TariffNaproxen 125mg/5ml oral suspension sugar free£110.00100 ml1 Oct 2026
NHS Drug TariffNaproxen 250mg effervescent tablets sugar free£52.7220 tablet1 Oct 2026
NHS Drug TariffNaproxen 250mg gastro-resistant tablets£3.8656 tablet1 Oct 2026
NHS Drug TariffNaproxen 250mg tablets£0.9628 tablet1 Oct 2026
NHS Drug TariffNaproxen 250mg/5ml oral suspension£90.00100 ml1 Oct 2026
NHS Drug TariffNaproxen 375mg gastro-resistant tablets£7.2156 tablet1 Oct 2026
NHS Drug TariffNaproxen 500mg gastro-resistant tablets£12.3556 tablet1 Oct 2026
NHS Drug TariffNaproxen 500mg tablets£1.3528 tablet1 Oct 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.

WHO WHO Model List of Essential Medicines (2025)

  • 5.1.5.1. Medicines for acute migraine attacks · core
    Therapeutic equivalent to ibuprofen for Migraine

Safety signals and safety-related labeling changes

All safety entries for naproxen →

Combinations containing Naproxen

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.