{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "safetyreportversion": "7", "safetyreportid": "14196345", "primarysourcecountry": "CA", "occurcountry": "CA", "transmissiondateformat": "102", "transmissiondate": "20180711", "reporttype": "2", "serious": "1", "seriousnessdeath": "1", "seriousnessdisabling": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20171116", "receiptdateformat": "102", "receiptdate": "20180606", "fulfillexpeditecriteria": "1", "companynumb": "PHHO2017CA015536", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHHO2017CA015536" }, "primarysource": { "reportercountry": "CA", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, 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Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]", "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SENNA", "drugdosagetext": "PRN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "6", "activesubstance": { "activesubstancename": "SENNA LEAF\\SENNOSIDES\\SENNOSIDES A AND B" }, "openfda": { "application_number": [ "M007", "505G(a)(3)", "M008" ], "brand_name": [ "SENNA", "SENNA TABS", "ONELAX SENNA" ], "generic_name": [ "SENNOSIDES 8.6 MG TABLETS", "SENNOSIDES", "SENNA LEAF", "SENNA" ], "manufacturer_name": [ "Aarkish Pharmaceuticals NJ Inc.", "American Health Packaging", "Family Dollar Services Inc", "Boiron", "H E B", "Patrin Pharma, Inc.", "AmerisourceBergen (Good Neighbor Pharmacy) 46122", "QUALITY CHOICE (Chain Drug Marketing Association)", "Pharbest Pharmaceuticals, Inc.", "Reliable 1 Laboratories LLC", "Major Pharmaceuticals", "Akron Pharma Inc.", "Rugby Laboratories", "AARNA USA INC.", "Rite Aid Corporation", "PAI Holdings, LLC dba PAI Pharma", "Walgreens" ], "product_ndc": [ "81005-101", "60687-851", "55319-298", "0220-4642", "37808-675", "39328-020", "39328-120", "39328-220", "0220-4643", "46122-702", "83324-004", "16103-363", "69618-069", "0904-7528", "37808-782", "71399-0027", "0536-1483", "82568-0006", "11822-0298", "0121-4967", "69618-064", "71399-1017", "82568-0024", "0363-8820" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "SENNOSIDES", "SENNA LEAF", "SENNOSIDES A AND B" ], "rxcui": [ "312935", "702311" ], "spl_id": [ "56d3eab0-0040-da54-e063-6294a90a09e2", "4860231c-fcbe-78df-e063-6394a90a26b0", "127bd8dd-7c0b-48ca-9662-1c5a6138b376", "3c591996-cf43-f089-e063-6394a90aff49", "cde8b1e7-b335-4d27-98bd-7686c5d660d9", "b42865b6-223b-461b-aabd-ca548a0339fa", "3b8d8a9c-2bea-881c-e063-6294a90abd8e", "ecb36956-0a73-4225-9f0a-a5286f7c6ee2", "22d033e2-47a4-4667-98a1-1968050a535f", "61f99f78-d945-4004-a167-f3a80979f4a4", "2de53996-629d-7455-e063-6294a90a21e4", "77e88305-734a-4b15-bbfe-67a32f02c143", "ffd1f134-7073-471d-9655-fc41a2543490", "5a6593f8-d323-3cb0-e063-6294a90a0dba", "94ef8dee-13d8-44b1-9eaa-fce49ed0cea6", "364d4dfc-a08a-1a27-e063-6394a90ad77b", "a8902034-4df3-4582-a632-07b003d46a2c", "788bfeed-afae-42ae-a24b-0634f35f000b", "2bc82d20-1476-46c7-e063-6394a90a0d44", "35428dd1-59c5-58f3-e063-6394a90af628", "d1e612c9-ccc5-4e54-912f-fdcdf2120e66", "b3e7783e-7909-46e5-8601-2684995904f6" ], "spl_set_id": [ "564bc9a5-13b5-4cce-a349-6b2e122683ed", "e3cbb71b-b45c-4ce1-820b-959dde04360d", "7dbcf9f4-eb98-41d9-9c2c-55d9d26942cb", "80b365a8-2911-1144-e053-2a91aa0a8985", "d047e4e9-b8ac-498e-9fde-8af5d415edaa", "a9f1ef8d-8700-481f-a709-972bb9d27153", "3b8d8a9c-2be9-881c-e063-6294a90abd8e", "da4b5f33-aee7-4c21-acf2-98649ec8bbf3", "1959ef47-95c1-4234-9e1c-ad679b8dfb77", "b9f8ea59-932f-4827-a87c-b4aff909c43f", "c8aa7ae9-7d00-db7d-e053-2995a90ae72b", "cfb6bf89-c77e-4372-9bc9-44d6a659c955", "60de7967-279c-478c-b4dd-e3b283375025", "27fa8f54-ed84-4afd-8da3-8754da48643b", "41d53783-7ac2-411c-b9bf-afd87b3af30d", "364d4dfc-a089-1a27-e063-6394a90ad77b", "f3a0938e-dbdb-4988-aa1e-78564948d6a0", "7c28ffb8-149f-4a5a-ab98-dfa7b3b0f6ed", "ae46a611-20f2-74c8-e053-2995a90a32ce", "55ce3969-d7a6-49c4-8c13-d95690efc1a6", "7ad21fb7-20eb-48d6-be15-450aa2ec97d3", "2875fe94-07a0-4e6e-b574-0d8d7cdf0a11" ], "package_ndc": [ "81005-101-30", "81005-101-10", "60687-851-40", "60687-851-46", "60687-851-77", "55319-298-12", "0220-4642-41", "37808-675-10", "39328-020-08", "39328-120-05", "39328-120-50", "39328-120-99", "39328-220-15", "39328-220-50", "0220-4643-41", "46122-702-78", "83324-004-01", "16103-363-08", "16103-363-11", "69618-069-58", "0904-7528-41", "0904-7528-94", "37808-782-10", "71399-0027-8", "0536-1483-59", "82568-0006-1", "82568-0006-2", "82568-0006-3", "11822-0298-2", "11822-0298-6", "11822-0298-4", "0121-4967-05", "0121-4967-40", "69618-064-01", "71399-1017-1", "71399-1017-2", "71399-1017-3", "82568-0024-8", "0363-8820-50", "0363-8820-10", "0363-8820-30" ], "unii": [ "3FYP5M0IJX", "AK7JF626KX", "1B5FPI42EN" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PEG", "drugdosagetext": "PRN", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "6", "activesubstance": { "activesubstancename": "POLYETHYLENE GLYCOLS" }, "openfda": { "application_number": [ "NDA019011", "NDA019797", "ANDA217505" ], "brand_name": [ "PEG 3350 AND ELECTROLYTES", "PEG 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE", "PEG3350" ], "generic_name": [ "POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE", "POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE", "POLYETHYLENE GLYCOL 3350" ], "manufacturer_name": [ "Wilshire Pharmaceuticals, Inc.", "Major Pharmaceuticals" ], "product_ndc": [ "52536-236", "52536-237", "52536-302", "0904-7534" ], "product_type": [ "HUMAN PRESCRIPTION DRUG", "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "POLYETHYLENE GLYCOL 3350", "SODIUM SULFATE ANHYDROUS", "SODIUM BICARBONATE", "SODIUM CHLORIDE", "POTASSIUM CHLORIDE" ], "rxcui": [ "966920", "801054", "876193" ], "spl_id": [ "b251752d-7750-482a-9364-0acf4ad47cc8", "4e442a72-b13b-4869-8a1d-59356095b091", "3e0f5355-f066-4626-8951-ee9aa0ff7c37" ], "spl_set_id": [ "b251752d-7750-482a-9364-0acf4ad47cc8", "4e442a72-b13b-4869-8a1d-59356095b091", "161629f6-6193-4712-bba7-7d5b174a9338" ], "package_ndc": [ "52536-236-01", "52536-237-01", "52536-302-01", "0904-7534-86", "0904-7534-26" ], "nui": [ "N0000010288", "N0000175811", "N0000009871" ], "pharm_class_moa": [ "Osmotic Activity [MoA]" ], "pharm_class_epc": [ "Osmotic Laxative [EPC]" ], "pharm_class_pe": [ "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]" ], "unii": [ "G2M7P15E5P", "36KCS0R750", "8MDF5V39QO", "451W47IQ8X", "660YQ98I10" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20171001" } } } ] }