Regulatory PathRegulatory requirements compared

Active substance

Acetylsalicylic acid

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ASPICARD 81MG TAB81 mgEnteric-coated tablet · Oral use120 BlisterSAR 30.00Generic · OTCTabuk Pharmaceutical Manufacturing CompanyValid
ASPIRIN ADULT TAB 300MG300 mgTablet · Oral use30 BlisterSAR 3.50Generic · OTCBAYER CONSUMER CARE AGValid
ASPIRIN PROTECT 100MG E.C. TABLETS100 mgEnteric-coated tablet · Oral use60 BlisterSAR 19.05NCE · OTCBAYER CONSUMER CARE AGValid
AZERA 100 mg enteric-coated tablet100 mgEnteric-coated tablet · Oral use90 Tablet ContainerSAR 6.35Generic · OTCUNITED PHARMACEUTICAL CO.Valid
DISPRIN81 mgEnteric-coated tablet · Oral use100 Tablet ContainerSAR 25.00Generic · OTCRIYADH PHARMAValid
JUSPRIN 81MG ENTERIC COATED TABLETS81 mgEnteric-coated tablet · Oral use30 BottleSAR 7.50Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
Jusprin81 mgEnteric-coated tablet · Oral use90 BottleSAR 22.50Generic · PrescriptionGulf Pharmaceutical Industries (Julphar)Valid
ADIPRIN 100MG E.C.TAB100 mgGastro-resistant coated tablet · Oral use30 BlisterSAR 2.35Generic · OTCTHE ARAB PHARMACEUTICAL MANUFACTURING PSCWithdrawn by MAH · Not Marketed
ADIPRIN 100MG E.C.TAB100 mgGastro-resistant coated tablet · Oral use100 BlisterSAR 6.75Generic · OTCTHE ARAB PHARMACEUTICAL MANUFACTURING PSCWithdrawn by MAH · Not Marketed
ASPICOT 100 MG E.C. TABLETS2 mgEnteric-coated tablet · Oral use100 BlisterSAR 2.00Generic · OTCPHARMALINEWithdrawn by MAH · Not Marketed
ASPICOT 100 MG E.C. TABLETS100 mgEnteric-coated tablet · Oral use30 BlisterSAR 0.70Generic · OTCPHARMALINEWithdrawn by MAH · Not Marketed
ASPIRIN ADULT TAB 300MG300 mgTablet · Oral use30 BlisterSAR 5.10Generic · OTCBAYER PHARMA AGWithdrawn by MAH · Not Marketed
ASPIRIN CHILDREN 100mg100 mgTablet · Oral use30 BlisterSAR 4.00Generic · OTCBAYER PHARMA AGSuspended · Not Marketed
ASPIRIN PROTECT 100MG E.C. TABLETS100 mgFilm-coated tablet · Oral use20 BlisterSAR 6.35Generic · OTCBAYER PHARMA AGWithdrawn by MAH · Not Marketed
ASPRO 320 MG TABLETS320 mgTablet · Oral use30 BlisterSAR 4.10Generic · OTCBAYER SANTE FAMILIALEWithdrawn by MAH · Not Marketed
ASPRO 320 MG TABLETS320 mgTablet · Oral use20 BlisterSAR 2.90Generic · OTCBAYER SANTE FAMILIALEWithdrawn by MAH · Not Marketed
HYPYRIN TAB 400MG400 mgTablet · Oral use100 Tablet ContainerSAR 17.55Generic · PrescriptionEISAIWithdrawn by MAH · Not Marketed
JUSPRIN 300MG ENTERIC COATED TABLETS300 mgEnteric-coated tablet · Oral use30 BlisterSAR 3.85Generic · OTCGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
JUSPRIN 500MG ENTERIC COATED TABLETS500 mgEnteric-coated tablet · Oral use20 BlisterSAR 4.05Generic · OTCGulf Pharmaceutical Industries (Julphar)Withdrawn by MAH · Not Marketed
KIDIPRIN CHEWABLE TABS 100MG100 mgChewable tablet · Oral use30 BlisterSAR 0.70Generic · OTCHikma Pharmaceuticals PLCWithdrawn by MAH · Not Marketed
NOVASEN 325MG E.C TAB325 mgGastro-resistant coated tablet · Oral use60 BlisterSAR 12.75Generic · OTCNOVOPHARMWithdrawn by MAH · Not Marketed
NOVASEN 325MG E.C TAB325 mgGastro-resistant coated tablet · Oral use30 BlisterSAR 7.25Generic · OTCNOVOPHARMWithdrawn by MAH · Not Marketed
NOVASEN 650MG E.C TAB650 mgGastro-resistant coated tablet · Oral use60 BlisterSAR 20.90Generic · PrescriptionNOVOPHARMWithdrawn by MAH · Not Marketed
NOVASEN 650MG E.C TAB650 mgGastro-resistant coated tablet · Oral use30 BlisterSAR 11.95Generic · PrescriptionNOVOPHARMWithdrawn by MAH · Not Marketed
REMIN TAB 300MG300 mgEffervescent tablet · Oral use30 BlisterSAR 0.75NCE · OTCAPMWithdrawn by MAH · Not Marketed

2 more — full table

Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ CARDIAC ARREST, CARDIOVASCULAR EMERGENCIES AND/OR DYSRHYTHMIAS; ANTIPHOSPHOLIPID SYNDROME; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); COLORECTAL CANCER-ADVANCED/ METASTATIC; CORONARY ARTERY DISEASE; DENTAL ABSCESS-DENTAL PAIN; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HIP AND KNEE REPLACEMENT SURGERY; HODGKIN'S LYMPHOMA; INFECTIOUS MONONUCLEOSIS; ISCHEMIC STROKE; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MATERNAL AND CHILD HEALTHCARE- PERINATAL,INTRAPARTUM AND POSTPARTUM CARE-PRE-ECLAMPSIA; MULTIPLE MYELOMA; MYELOFIBROSIS-ADVERSE REACTION MANAGEMENT; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); PERICORONITIS; POLYCYTHEMIA VERA; PULMONARY EMBOLISM; SINUSITIS; ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI); SYSTEMIC LUPUS ERYTHEMATOSUS; T-CELL LYMPHOMA-RENAL TOXICITY; THROMBOTIC THROMBOCYTOPENIC PURPURA; VENOUS THROMBOEMBOLISM DISEASE (VTE)-PROPHYLAXIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
VAZALORE325MG; 81MGcapsule · oralPLX PHARMAOver-the-counter14 Jan 2013
8-HOUR BAYER650MGtablet, extended release · oralBAYERDiscontinued25 Jun 1965
MEASURIN650MGtablet, extended release · oralBAYERDiscontinued25 Jun 1965
BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN500MGtablet · oralBAYERDiscontinued18 Oct 2001
DURLAZA162.5MGcapsule, extended release · oralHESPDiscontinued4 Sep 2015

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ASA0243304481 MGTABLET (DELAYED-RELEASE) · ORALPHARMASCIENCE INC
ASA 325MG00530336325 MGTABLET · ORALVITA HEALTH PRODUCTS INC
ASA 81 MG0224499381 MGTABLET (DELAYED-RELEASE) · ORALPHARMASCIENCE INC
ASA 81 MG0237217781 MGTABLET (DELAYED-RELEASE) · ORALVITA HEALTH PRODUCTS INC
ASA DAILY LOW DOSE0239479081 MGTABLET (CHEWABLE) · ORALPHARMASCIENCE INC
ASAPHEN0200901380 MGTABLET (CHEWABLE) · ORALPHARMASCIENCE INC
ASAPHEN E.C. 80 MG0223854580 MGTABLET (DELAYED-RELEASE) · ORALPHARMASCIENCE INC
ASPIRIN 81MG0223772681 MGTABLET (ENTERIC-COATED) · ORALBAYER INC
ASPIRIN 81MG QUICK CHEWS0228997081 MGTABLET (CHEWABLE) · ORALBAYER INC
ASPIRIN COATED FOR DELAYED RELEASE REGULAR STRENGTH02150417325 MGTABLET (DELAYED-RELEASE) · ORALBAYER INC
ASPIRIN EXTRA STRENGTH02150336500 MGTABLET · ORALBAYER INC
ASPIRIN REGULAR STRENGTH02150328325 MGTABLET · ORALBAYER INC
ENTERIC COATED DAILY LOW DOSE ASA 81 MG0236312781 MGTABLET (DELAYED-RELEASE) · ORALVITA HEALTH PRODUCTS INC
ENTROPHEN0224228181 MGTABLET (DELAYED-RELEASE) · ORALPENDOPHARM DIVISION OF PHARMASCIENCE INC
ENTROPHEN CHEWABLE0224397481 MGTABLET (CHEWABLE) · ORALPENDOPHARM DIVISION OF PHARMASCIENCE INC
JAMP-ASA 81MG EC0242720681 MGTABLET (ENTERIC-COATED) · ORALVITA HEALTH PRODUCTS INC
JAMP-ASA CHEW0226913980 MGTABLET (CHEWABLE) · ORALJAMP PHARMA CORPORATION
JAMP-ASA EC0228390580 MGTABLET (DELAYED-RELEASE) · ORALJAMP PHARMA CORPORATION
M-ASA 80 MG CROQUABLE0242995080 MGTABLET (CHEWABLE) · ORALMANTRA PHARMA INC
PRAXIS ASA EC 81 MG DAILY LOW DOSE0228370081 MGTABLET (DELAYED-RELEASE) · ORALPHARMASCIENCE INC
PRO-AAS - 80 (CROQUABLE)0231151880 MGTABLET (CHEWABLE) · ORALPRO DOC LIMITEE
PRO-AAS EC - 800231149680 MGTABLET (DELAYED-RELEASE) · ORALPRO DOC LIMITEE
REGULAR STRENGTH ASA02551217325 MGTABLET · ORALLNK INTERNATIONAL INC.
RIVASA 80 MG EC0248522280 MGTABLET (DELAYED-RELEASE) · ORALLABORATOIRE RIVA INC.
RIVASA 80MG CROQUABLE - TAB0220235280 MGTABLET (CHEWABLE) · ORALLABORATOIRE RIVA INC.

2 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACASPIRIN 325 MG TABLET$0.0166per EA23 Sep 2026
US NADACASPIRIN 81 MG CHEWABLE TABLET$0.02571per EA23 Sep 2026
US NADACASPIRIN EC 325 MG TABLET$0.02216per EA23 Sep 2026
US NADACASPIRIN EC 81 MG TABLET$0.01418per EA23 Sep 2026
US NADACFT ASPIRIN 325 MG TABLET$0.0166per EA23 Sep 2026
US NADACFT ASPIRIN 81 MG CHEWABLE TAB$0.02571per EA23 Sep 2026
US NADACFT ASPIRIN EC 325 MG TABLET$0.02216per EA23 Sep 2026
US NADACFT ASPIRIN EC 81 MG TABLET$0.01418per EA23 Sep 2026
US NADACGNP ASPIRIN 325 MG TABLET$0.0166per EA23 Sep 2026
US NADACGNP ASPIRIN EC 81 MG TABLET$0.01418per EA23 Sep 2026
US NADACGS ASPIRIN 81 MG CHEWABLE TAB$0.02571per EA23 Sep 2026
US NADACQC ASPIRIN 325 MG TABLET$0.0166per EA23 Sep 2026
NHS Drug TariffAspirin 150mg suppositories£28.9710 suppository1 Oct 2026
NHS Drug TariffAspirin 300mg dispersible tablets£0.9432 tablet1 Oct 2026
NHS Drug TariffAspirin 300mg gastro-resistant tablets£72.08100 tablet1 Oct 2026
NHS Drug TariffAspirin 300mg suppositories£55.6810 suppository1 Oct 2026
NHS Drug TariffAspirin 300mg tablets£0.8732 tablet1 Oct 2026
NHS Drug TariffAspirin 300mg tablets£2.73100 tablet1 Oct 2026
NHS Drug TariffAspirin 75mg dispersible tablets£2.5828 tablet1 Oct 2026
NHS Drug TariffAspirin 75mg dispersible tablets£9.21100 tablet1 Oct 2026
NHS Drug TariffAspirin 75mg gastro-resistant tablets£2.1228 tablet1 Oct 2026
NHS Drug TariffAspirin 75mg tablets£2.1228 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
    Migraine
    Oral > Solid: 300 to 500 mg
  • 12.5.1. Anti-platelet medicines · core
    Acute myocardial infarction; Cerebral ischaemic stroke
    Oral > Solid: 100 mg
  • 29.3. Medicines for juvenile joint diseases · complementary
    Mucocutaneous lymph node syndrome; Juvenile idiopathic arthritis; Acute rheumatic fever without mention of heart involvement
    Local > Rectal > Suppository: 150 mg; 300 mg | Oral > Solid > dispersible tablet: 75 mg; 300 mg; 500 mg | Oral > Solid > tablet: 75 to 500 mg
  • 2.1. Non-opioids and non-steroidal anti-inflammatory medicines (NSAIMs) · core
    Pain
    Oral > Solid: 100 to 500 mg | Local > Rectal > Suppository: 50 to 150 mg

Safety signals and safety-related labeling changes

All safety entries for acetylsalicylic acid →

Combinations containing Acetylsalicylic acid

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.