{"id":"aspirin","rwe":[],"_fda":{"id":"008ee85b-5cac-45a6-a857-a828f8125175","set_id":"0058175f-3474-40c3-a046-6cfaec86d84b","openfda":{"nui":["N0000000160","N0000008836","M0001335","N0000175722","N0000175578","N0000008832"],"upc":["0359726443012"],"unii":["R16CO5Y76E"],"route":["ORAL"],"rxcui":["308416"],"spl_id":["008ee85b-5cac-45a6-a857-a828f8125175"],"brand_name":["Low Dose Aspirin"],"spl_set_id":["0058175f-3474-40c3-a046-6cfaec86d84b"],"package_ndc":["59726-065-30"],"product_ndc":["59726-065"],"generic_name":["ASPIRIN"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Anti-Inflammatory Agents, Non-Steroidal [CS]"],"pharm_class_pe":["Decreased Prostaglandin Production [PE]","Decreased Platelet Aggregation [PE]"],"substance_name":["ASPIRIN"],"pharm_class_epc":["Nonsteroidal Anti-inflammatory Drug [EPC]","Platelet Aggregation Inhibitor [EPC]"],"pharm_class_moa":["Cyclooxygenase Inhibitors [MoA]"],"manufacturer_name":["P & L Development, LLC"],"application_number":["M013"],"is_original_packager":[true]},"purpose":["Purpose Pain reliever"],"version":"3","stop_use":["Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stool have stomach pain that does not get better pain gets worse or lasts more than 10 days redness or swelling is present ringing in the ears or loss of hearing occurs new symptoms occur These could be signs of a serious condition"],"warnings":["Warnings Reye's syndrome : Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert : Aspirin may cause a severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer. if you have ever had an allergic reaction to his product or any of its ingredients Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stool have stomach pain that does not get better pain gets worse or lasts more than 10 days redness or swelling is present ringing in the ears or loss of hearing occurs new symptoms occur These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"questions":["Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"ask_doctor":["Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma"],"do_not_use":["Do not use if you are allergic to aspirin or any other pain reliever/fever reducer. if you have ever had an allergic reaction to his product or any of its ingredients"],"effective_time":"20240416","active_ingredient":["Active ingredient (in each tablet) Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug"],"inactive_ingredient":["Inactive ingredients croscarmellose sodium, D&C yellow #10, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose 102 polacrilin potassium, polyethylene glycol 6000, polyvinyl alcohol, purified water, talc, silicon dioxide, sodium lauryl sulfate, soybean, titanium dioxide, triethyl citrate"],"storage_and_handling":["Other information store between 15-30ºC (59-86ºF)"],"indications_and_usage":["Uses for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. ask your doctor about other uses for safety coated 81 mg aspirin"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis"],"dosage_and_administration":["Directions drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor"],"spl_product_data_elements":["Low Dose Aspirin Aspirin ASPIRIN ASPIRIN D&C YELLOW NO. 10 CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE METHACRYLIC ACID SILICON DIOXIDE POLACRILIN POTASSIUM SODIUM LAURYL SULFATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE POLYETHYLENE GLYCOL 6000 SOYBEAN POLYVINYL ALCOHOL, UNSPECIFIED P"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"package_label_principal_display_panel":["Principal Display Panel Compare to the active ingredient in Bayer® Low Dose Aspirin† EASY OPEN CAP Low Dose Aspirin 81 mg Pain reliever (NSAID) ≠aspirin regimen ≠safety coated THIS PACKAGE NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN enteric coated tablets ≠≠Coating helps protect against stomach upset †This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer® Low Dose Aspirin. ≠Talk to your doctor or other healthcare provider before using this product for your heart. Aspirin is not right for everyone. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: PL Developments 200 Hicks Street Westbury, NY 11590","Product Label READYinCASE Low Dose Aspirin 81 mg Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"approved","trials":["NCT00905008","NCT01812200","NCT07338331","NCT00731302","NCT02146664","NCT02243137","NCT01617031","NCT02247128","NCT05926271","NCT06738992","NCT01432652","NCT02838030","NCT04273516","NCT05567536","NCT00033319","NCT05637567","NCT03218293","NCT01559298","NCT02081638","NCT00449618","NCT05625724","NCT04363840","NCT05073718","NCT04936191","NCT06336174","NCT05644210","NCT00576160","NCT06853535","NCT00841789","NCT01962545","NCT04070573","NCT00759629","NCT02611973","NCT00938522","NCT05643651","NCT02168829","NCT06449469","NCT00611169","NCT05122741","NCT04557475","NCT00946907","NCT00742430","NCT01396395","NCT01274767","NCT01113528","NCT03378934","NCT04937699","NCT04974892","NCT01511939","NCT06723145"],"aliases":["ASA","Bayer Aspirin","Ecotrin","Bufferin"],"patents":[],"pricing":[],"_sources":{"_fda":{"url":"","method":"api_direct","source":"FDA OpenFDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:54:38.004254+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"Haiku strategic summary","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T07:54:39.851902+00:00"}},"offLabel":[],"timeline":[],"aiSummary":"Acetylsalicylic acid (Aspirin) is indicated for temporary relief of minor aches and pains or as recommended by a doctor. The product has delayed action and will not provide fast relief of headaches or symptoms needing immediate relief. The label recommends consulting a doctor about other uses for safety-coated 81 mg aspirin formulations. Mechanism of action, pharmacokinetics, contraindications, and drug interactions are not available in the provided label text.","brandName":"Aspirin","companyId":"bayer","ecosystem":[],"mechanism":{"target":"Gamma-glutamyltranspeptidase 1, Nicotinate phosphoribosyltransferase, Acid-sensing ion channel 3","novelty":"","modality":"Small molecule","drugClass":"NSAID, Antiplatelet agent","explanation":"Aspirin irreversibly acetylates cyclooxygenase enzymes, permanently blocking the production of prostaglandins (which mediate pain and inflammation) and thromboxane A2 (which promotes platelet aggregation). This dual action makes it unique among NSAIDs — at low doses (75-100mg daily) it is used for cardiovascular protection by preventing blood clots, while at higher doses (300-900mg) it provides analgesic and anti-inflammatory effects. First synthesized by Bayer in 1897, aspirin is the oldest NSAID still in widespread use and remains on the WHO Model List of Essential Medicines.","oneSentence":"Irreversibly inhibits cyclooxygenase-1 and -2 (COX-1/COX-2), blocking prostaglandin and thromboxane synthesis to reduce pain, inflammation, fever, and platelet aggregation.","technicalDetail":""},"commercial":{"revenueYear":2023,"annualRevenue":1000,"revenueSource":"Groq: Bayer 10-K FY2023","revenueCurrency":"USD","revenueConfidence":"groq-knowledge"},"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T08:26:24.874853+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"companyName":"Bayer AG","competitors":[],"genericName":"acetylsalicylic acid","indications":{"approved":[{"name":"Arthritic Pain","diseaseId":"arthritic-pain","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Backache","diseaseId":"backache","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Common cold","diseaseId":"common-cold","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Headache disorder","diseaseId":"headache-disorder","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Influenza-like symptoms","diseaseId":"influenza-like-symptoms","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Joint pain","diseaseId":"joint-pain","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Migraine","diseaseId":"migraine","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Myocardial infarction","diseaseId":"myocardial-infarction","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Osteoarthritis","diseaseId":"osteoarthritis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pain","diseaseId":"pain","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Rheumatoid arthritis","diseaseId":"rheumatoid-arthritis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Sinus headache","diseaseId":"sinus-headache","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Toothache","diseaseId":"toothache","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00905008","phase":"N/A","title":"Long-Term Safety and Efficacy of Drug Eluting Stents in \"Real World\" - 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A Randomized Pilot Study (the ARTE Trial)","status":"COMPLETED","sponsor":"Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec","isPivotal":false,"enrollment":178,"indication":"Aortic Valve Disease, Myocardial Infarction","completionDate":"2016-03"},{"nctId":"NCT02081638","phase":"Phase 2","title":"Elite Controller and ART-Treated HIV+ Statin Versus ASA Treatment Intervention Study","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","isPivotal":false,"enrollment":53,"indication":"Human Immunodeficiency Virus","completionDate":"2019-10-16"},{"nctId":"NCT00449618","phase":"Phase 4","title":"A Prospective, Randomized, Multi-Center, Double-Blind Crossover Study to Compare Awakening Versus Bedtime Administration of 100 mg Aspirin or Placebo in Subjects With High-Normal Blood Pressure or Mil","status":"TERMINATED","sponsor":"University of Vigo","isPivotal":false,"enrollment":23,"indication":"High-Normal Blood Pressure, Mild Essential Hypertension","completionDate":"2008-12"},{"nctId":"NCT05625724","phase":"Phase 3","title":"Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes in Nulliparous Women After Assisted Reproductive Technology. 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