Regulatory PathRegulatory requirements compared

Active substance

Diclofenac

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ANNUVA 50 mg Tablet50 mgTablet · Oral use20 BlisterSAR 17.65Generic · PrescriptionDAMMAM PHARMAValid
APO-DICLO 50 mg enteric-coated tablet50 mgEnteric-coated tablet · Oral use20 BlisterSAR 19.80Generic · PrescriptionAPOTEXValid
AQUAFLAM 50 MG SACHET50 mgPowder for oral solution · Oral use12 SachetSAR 24.00Generic · PrescriptionRIYADH PHARMAValid
Avotrene Emulgel1 %Gel · Topical1 TubeSAR 14.40Generic · OTCMiddle East Pharmaceutical Industries Co Ltd Avalon PharmaValid
CATAFAST 50 MG SACHET50 mgPowder for oral suspension · Oral use9 SachetSAR 18.00NCE · PrescriptionNOVARTIS PHARMA AGValid
CATAFLAM 50MG TABLET50 mgCoated tablet · Oral use20 BlisterSAR 31.70Generic · PrescriptionNOVARTIS PHARMA AGValid
CLOFAST 1% GEL1 %Gel · Topical1 TubeSAR 3.50Generic · OTCOMAN PHARMACEUTICAL PRODUCTSValid
CLOFAST-P 50 mg tablet50 mgTablet · Oral use20 BlisterSAR 9.10Generic · PrescriptionOMAN PHARMACEUTICAL PRODUCTSValid
CLOFEN 75MG INJECTION25 mg/mlSolution for injection · Parenteral use5 AmpouleSAR 25.65Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
CLOFEN CREAMAGEL 1%1 %Cream · Topical1 TubeSAR 3.90Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
CLOFEN CREAMAGEL 1%1 %Cream · Topical1 TubeSAR 8.00Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
Catafenac50 mgPowder for oral solution · Oral use20 SachetSAR 40.00Generic · PrescriptionSaudi AmaroxValid
Catafenac50 mgPowder for oral solution · Oral use10 SachetSAR 20.00Generic · PrescriptionSaudi AmaroxValid
DICLAC 75MG ID TABLETS75 mgProlonged-release tablet · Oral use20 BlisterSAR 24.85Generic · PrescriptionHEXALValid
DICLOGESIC12.5 mgSuppository · Rectal use10 BlisterSAR 4.60Generic · PrescriptionDAR ALDAWAValid
DICLOGESIC100 mgSuppository · Rectal use5 BlisterSAR 11.40Generic · PrescriptionDAR ALDAWAValid
DICLOGESIC 50MG SUPPOSITORY50 mgSuppository · Rectal use10 BlisterSAR 6.35Generic · PrescriptionDAR ALDAWAValid
DICLOGESIC RETARD100 mgFilm-coated tablet · Oral use10 BlisterSAR 9.05Generic · PrescriptionDAR ALDAWAValid
DICLOGESIC RETARD100 mgCapsule · Oral use12 BlisterSAR 17.20Generic · PrescriptionDAR ALDAWAValid
DICLOGESIC RETARD100 mgCoated tablet · Oral use500 BlisterSAR 345.20Generic · PrescriptionDAR ALDAWAValid
DICLOMAX50 mgTablet · Oral use160 BlisterSAR 141.20Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
DICLOMAX 1% EMULGEL1 %Gel · Topical1 TubeSAR 10.55Generic · OTCJazeera Pharmaceutical Industries (JPI)Valid
DICLOMAX 25MG TAB25 mgTablet · Oral use30 BlisterSAR 14.85Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
DICLOMAX 50 MG TAB50 mgTablet · Oral use20 BlisterSAR 19.80Generic · PrescriptionJazeera Pharmaceutical Industries (JPI)Valid
DICLON 1% EMULGEL1 %Gel · Topical1 TubeSAR 9.30Generic · OTCMEDPHARMA PHARMACEUTICAL & CHEMICAL INDUSTRIESValid

106 more — full table

Indications — CHI Daman Drug Formulary

ACUTE PANCREATITIS-PAIN MANAGEMENT; ANKYLOSING SPONDYLITIS; BACTERIAL TONSILLOPHARYNGITIS TREATMENT AND PREVENTION; CHRONIC PANCREATITIS; DENTAL ABSCESS-DENTAL PAIN; ENDOMETRIOSIS; ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; EPIDERMOLYSIS BULLOSA; GOUT; INFLUENZA-SYMPTOMATIC TREATMENT; 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; 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
DICLOFENAC SODIUM50MG; 75MGtablet, delayed release · oralACTAVIS ELIZABETHPrescription26 Mar 1996
DICLOFENAC POTASSIUM50MGtablet · oralTEVAPrescription6 Aug 1998
DICLOFENAC SODIUM75MG; 25MG; 50MGtablet, delayed release · oralCARLSBADPrescription13 Nov 1998
DICLOFENAC POTASSIUM50MG; 25MG; 75MGtablet · oralRUBICON RESEARCHPrescription20 Nov 1998
DICLOFENAC POTASSIUM50MGtablet · oralRISINGPrescription26 Jul 1999
DICLOFENAC SODIUM100MGtablet, extended release · oralVPNAPrescription11 Feb 2000
DICLOFENAC SODIUM100MGtablet, extended release · oralAUROBINDO PHARMA USAPrescription13 Dec 2001
DICLOFENAC SODIUM50MG; 75MGtablet, delayed release · oralAUROBINDO PHARMA USAPrescription12 Feb 2002
DICLOFENAC SODIUM100MGtablet, extended release · oralDEXCEL LTDPrescription6 Nov 2002
CATAFLAM50MG; 25MGtablet · oralAMICI PHARMAPrescription18 Mar 2004
DICLOFENAC SODIUM75MGtablet, delayed release · oralUNIQUEPrescription8 Jun 2007
VOLTAREN ARTHRITIS PAIN1%gel · topicalHALEON US HOLDINGSOver-the-counter17 Oct 2007
DICLOFENAC SODIUM0.1%solution/drops · ophthalmicRISINGPrescription28 Dec 2007
DICLOFENAC SODIUM0.1%solution/drops · ophthalmicBAUSCH AND LOMBPrescription28 Dec 2007
DICLOFENAC SODIUM0.1%solution/drops · ophthalmicSANDOZPrescription6 Feb 2008
DICLOFENAC SODIUM0.1%solution/drops · ophthalmicRUBICON RESEARCHPrescription13 Nov 2008
ZIPSOR25MGcapsule · oralCOSETTEPrescription16 Jun 2009
CAMBIA50MGfor solution · oralCOSETTEPrescription17 Jun 2009
DICLOFENAC SODIUM25MG; 50MGtablet, delayed release · oralUNIQUEPrescription1 Dec 2010
DICLOFENAC SODIUM1.5%solution · topicalWATSON LABS INCPrescription24 Nov 2014
DICLOFENAC SODIUM1.5%solution · topicalSUN PHARMA CANADAPrescription26 Nov 2014
DICLOFENAC SODIUM1.5%solution · topicalLUPINPrescription20 Aug 2015
DICLOFENAC SODIUM0.1%solution/drops · ophthalmicALTAIRE PHARMS INCPrescription16 Nov 2015
DICLOFENAC SODIUM3%gel · topicalACTAVIS MID ATLANTICPrescription2 Dec 2015
DICLOFENAC SODIUM1.5%solution · topicalNOVEL LABS INCPrescription9 Dec 2015

65 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-DICLO0083917525 MGTABLET (ENTERIC-COATED) · ORALAPOTEX INC
APO-DICLO0083918350 MGTABLET (ENTERIC-COATED) · ORALAPOTEX INC
APO-DICLO SR02091194100 MG / SRTTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
APO-DICLO SR0216281475 MGTABLET (EXTENDED-RELEASE) · ORALAPOTEX INC
CAMBIA0238168050 MG / SACHETPOWDER FOR SOLUTION · ORALARALEZ PHARMACEUTICALS CANADA INC
DICLOFENAC024750650.1 % / W/VSOLUTION · OPHTHALMICPHARMA STULLN INC.
JAMP DICLOFENAC025345250.1 % / W/VSOLUTION · OPHTHALMICJAMP PHARMA CORPORATION
JAMP DICLOFENAC FOR SOLUTION0256329050 MG / SACHETPOWDER FOR SOLUTION · ORALJAMP PHARMA CORPORATION
JAMP DICLOFENAC TOPICAL SOLUTION024723091.5 % / W/WSOLUTION · TOPICALJAMP PHARMA CORPORATION
PENNSAID022472651.5 % / W/WSOLUTION · TOPICALKNIGHT THERAPEUTICS INC.
PMS-DICLOFENAC0230261625 MGTABLET (DELAYED-RELEASE) · ORALPHARMASCIENCE INC
PMS-DICLOFENAC0230262450 MGTABLET (DELAYED-RELEASE) · ORALPHARMASCIENCE INC
PRO-DICLOFENAC0087097850 MGTABLET (DELAYED-RELEASE) · ORALPRO DOC LIMITEE
RIVA-DICLOFENAC0256063150 MG / SACHETPOWDER FOR SOLUTION · ORALLABORATOIRE RIVA INC.
SANDOZ DICLOFENAC RAPIDE0226177450 MGTABLET · ORALSANDOZ CANADA INCORPORATED
SANDOZ-DICLOFENAC0226192850 MGSUPPOSITORY · RECTALSANDOZ CANADA INCORPORATED
TARO-DICLOFENAC024209881.5 % / W/WSOLUTION · TOPICALTARO PHARMACEUTICALS INC
TARO-DICLOFENAC POTASSIUM POWDER FOR ORAL SOLUTION0256447550 MG / SACHETPOWDER FOR SOLUTION · ORALTARO PHARMACEUTICALS INC
TEVA-DICLOFENAC EC0080854750 MGTABLET (ENTERIC-COATED) · ORALTEVA CANADA LIMITED
TEVA-DICLOFENAC SR0215858275 MGTABLET (EXTENDED-RELEASE) · ORALTEVA CANADA LIMITED
TEVA-DICLOFENAC-K0223935550 MGTABLET · ORALTEVA CANADA LIMITED
VOLTAREN0063272450 MGSUPPOSITORY · RECTALNOVARTIS PHARMACEUTICALS CANADA INC
VOLTAREN RAPIDE0088163550 MGTABLET · ORALNOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDICLOFENAC 0.1% EYE DROPS$1.69541per ML23 Sep 2026
US NADACDICLOFENAC 0.1% EYE DROPS$1.7496per ML23 Sep 2026
US NADACDICLOFENAC 1.5% TOPICAL SOLN$0.12941per ML23 Sep 2026
US NADACDICLOFENAC 2% SOLUTION PUMP$0.42962per GM23 Sep 2026
US NADACDICLOFENAC POT 25 MG TABLET$4.56677per EA23 Sep 2026
US NADACDICLOFENAC POT 50 MG POWDR PKT$10.97187per EA23 Sep 2026
US NADACDICLOFENAC POT 50 MG TABLET$0.11246per EA23 Sep 2026
US NADACDICLOFENAC POTASSIUM 25 MG CAP$2.80711per EA30 Sep 2026
US NADACDICLOFENAC SOD DR 25 MG TAB$0.68438per EA23 Sep 2026
US NADACDICLOFENAC SOD DR 50 MG TAB$0.06233per EA23 Sep 2026
US NADACDICLOFENAC SOD DR 75 MG TAB$0.06194per EA23 Sep 2026
US NADACDICLOFENAC SOD EC 25 MG TAB$0.68438per EA23 Sep 2026
NHS Drug TariffDiclofenac 0.1% eye drops£6.685 ml1 Oct 2026
NHS Drug TariffDiclofenac 0.1% eye drops 0.3ml unit dose preservative free£32.0040 unit dose1 Oct 2026
NHS Drug TariffDiclofenac 100mg suppositories£2.7310 suppository1 Oct 2026
NHS Drug TariffDiclofenac 12.5mg suppositories£0.7010 suppository1 Oct 2026
NHS Drug TariffDiclofenac 140mg medicated plasters£13.015 plaster1 Oct 2026
NHS Drug TariffDiclofenac 25mg suppositories£1.2410 suppository1 Oct 2026
NHS Drug TariffDiclofenac 50mg suppositories£2.0410 suppository1 Oct 2026
NHS Drug TariffDiclofenac 75mg/3ml solution for injection ampoules£9.9110 ampoule1 Oct 2026
NHS Drug TariffDiclofenac potassium 50mg tablets£7.9430 tablet1 Oct 2026
NHS Drug TariffDiclofenac sodium 1% gel£6.45100 gram1 Oct 2026
NHS Drug TariffDiclofenac sodium 100mg modified-release capsules£8.2028 capsule1 Oct 2026
NHS Drug TariffDiclofenac sodium 100mg modified-release tablets£11.3328 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.

Safety signals and safety-related labeling changes

All safety entries for diclofenac →

Combinations containing Diclofenac

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.