{ "summary": { "safetyreportid": "21298311", "receivedate": "20220905", "serious": "1", "seriousnessdeath": "2", "age": "69", "sex": "2", "drugs": [ "SODIUM CHLORIDE", "SODIUM CHLORIDE", "CHLORINE DIOXIDE", "VITAMINS" ], "reactions": [ "Throat irritation", "Asthenia", "Feeling cold" ], "source_url": "/docs/faers/21298311.html" }, "raw": { "safetyreportversion": "1", "safetyreportid": "21298311", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20221027", "reporttype": "1", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedate": "20220905", "receiptdate": "20220905", "fulfillexpeditecriteria": "3", "authoritynumb": "FDA-CDER-CTU-2022-71005", "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "69", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Throat irritation" }, { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Asthenia" }, { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Feeling cold" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "SODIUM CHLORIDE", "drugauthorizationnumb": "99", "drugseparatedosagenumb": "-1", "drugdosagetext": "FREQUENCY : AS NEEDED;?", "drugadministrationroute": "048", "drugindication": "Hypothyroidism", "drugstartdateformat": "102", "drugstartdate": "20190201", "drugrecurreadministration": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "SODIUM CHLORIDE" }, "openfda": { "application_number": [ "NDA018897", "NDA019635", "ANDA201833", "M022", "M018", "ANDA213688", "ANDA207310", "NDA020178", "NDA019319", "ANDA208122", "ANDA209476", "NDA018314", "505G(a)(3)", "part349", "NDA202832", "NDA021569", "M012", "NDA018800", "ANDA212248", "ANDA078177", "NDA017464", "ANDA088912", "NDA016733", "NDA018016", "NDA016677", "ANDA206171", "NDA018803", "NDA017867", "NDA018090", "NDA016366", "NDA017427", "ANDA212070", "ANDA217796", "NDA019465", "ANDA211968", "NDA019022", "ANDA088911" ], "brand_name": [ "SODIUM CHLORIDE", "CVS HEALTH STERILE SALINE MIST", "HYPERTONIC SALINE", "LICEFREEE EVERYDAY", "SALINE CLEANING", "AQUA MARINA", "NATRUM MURIATICUM", "STERILE SALINE MIST WALGREENS", "SALINE NASAL", "WALGREENS", "MURO 128", "CVS HEALTH STERILE SALINE MIST LIVE BETTER", "0.9SALINE", "WHWSWB 0.9% SALINE", "HYPERTONIC SALINE SOLUTION SODIUM CHLORIDE", "RESP EASE", "STERILE SALINE MIST RITE AID", "DG HEALTH STERILE SALINE MIST", "WALGREENS SODIUM CHLORIDE OPHTHALMIC 5 PERCENT HYPERTONICITY EYE", "SODIUM CHLORIDE HYPERTONICITY", "SINUCLEANSE NASAL DRIP", "D-129", "WORAFY GENTLE EYE WASH", "0.9% SODIUM CHLORIDE SALINE SOLUTION", "LICEFREEE", "SODIUM CHLORIDE NORMAL SALT", "ALTACHLORE SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC 5 PERCENT", "STERILE SALINE KIDS MIST PEDIAMEDS", "QUALITY CHOICE SALINE", "STERILE SALINE MIST MEIJER", "SINUCLEANSE STERILE SALINE MIST DAILY CARE", "WINCO FOODS SALINE NASAL RELIEF", "0.9 PERCENTSALINE", "BASE LABORATORIES SALINE", "RHINOMEL MANUKA", "WALGREENS SALINE MIST EXTRA STRENGTH", "NATRUM MURIATICUM 6X", "FAMILY CARE SALINE", "BACTERIOSTATIC SODIUM CHLORIDE", "ANCIENT SECRETS BREATHE AGAIN", "STERILE HYPERTONIC SALINE SOLUTION 7 SODIUM CHLORIDE", "NACL 0.9% NORMAL SALINE SOLUTION", "EXTRA STRENGHT SALINE MIST RITE AID", "NORMAL SALT", "HYDRA NEB", "NAT MUR", "SINUCLEANSE STERILE SALINE MIST", "ALTACHLORE SODIUM CHLORIDE HYPERTONICITY", "STERILE SALINE KIDS MIST SINUCLEANSE BREATHE", "NAT MUR 6X", "0.9%SALINE", "SODIUM CHLORIDE 1 GRAM", "SODIUM CHLORIDE OPHTHALMIC 5 PERCENT HYPERTONICITY EYE", "OIMMAL GENTLE EYE WASH", "WILD HORSE 777 MOISTURIZING NASAL", "EQUATE STERILE SALINE MIST", "NATRIUM MURIATICUM 6X" ], "generic_name": [ "SODIUM CHLORIDE", "SODIUM CHLORIDE TABLET", "SODIUM CHLORIDE TABLETS" ], "manufacturer_name": [ "Hospira, Inc.", "CVS Pharmacy", "NAVEH PHARMA (1996) LTD", "B. Braun Medical Inc.", "Tec Laboratories,Inc.", "Guangzhou Huanmei Cosmetics Co., Ltd.", "Hikma Pharmaceuticals USA Inc.", "Boiron", "Fresenius Kabi USA, LLC", "WALGREEN COMPANY", "ALAINA HEALTHCARE PRIVATE LIMITED", "Walgreen Company", "Bausch & Lomb Incorporated", "Becton Dickinson and Company", "Huizhou Jinsheng Medical Technology Co., Ltd", "Yiwu Huanshu E-commerce Co., Ltd", "Laboratoire Unither", "Baxter Healthcare Corporation", "RITE AID", "DG Health", "CVS PHARMACY", "Hyland's Inc.", "ASCENT CONSUMER PRODUCTS, INC", "DNA Labs, Inc.", "ICU Medical Inc.", "Shenzhen Shandian Jingling Technology Co., Ltd.", "Yunqi Cosmetics (Shenzhen) Co., Ltd", "Baxter Healthcare Company", "Tec Laboratories, Inc.", "Method Pharmaceuticals", "Belleview Bioscience LLC", "Altaire Pharmaceuticals Inc.", "ASCENT CONSUMER PRODUCTS, INC.", "Advanced Rx LLC", "QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)", "SEVENE USA", "Meijer, Inc.", "WinCo Foods, LLC", "Joonem LLC", "Medefil, Inc.", 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"80327-013-00", "79903-325-05", "24208-277-15", "24208-277-30", "24208-277-59", "0220-3595-41", "0487-4301-25", "0487-4301-10", "0487-4301-05", "0487-4301-50", "70369-010-09", "63323-090-02", "63323-090-20", "63323-090-04", "63323-090-40", "62106-1058-2", "0338-0054-03", "0338-0056-03", "57237-361-01", "58657-119-01", "0264-7800-00", "0264-7800-10", "0264-7800-20", "0264-7802-00", "0264-7802-10", "70369-007-02", "70369-007-03", "70369-007-07", "65219-502-01", "65219-502-10", "65219-504-02", "65219-504-20", "65219-506-03", "65219-506-30", "63323-924-01", "63323-924-10", "63323-924-03", "63323-924-30", "17271-701-02", "17271-701-03", "17271-701-05", "17271-701-06", "17271-701-07" ], "unii": [ "451W47IQ8X", "LYR4M0NH37" ], "nui": [ "N0000175811", "N0000009371", "N0000009726", "N0000010288" ], "pharm_class_epc": [ "Osmotic Laxative [EPC]" ], "pharm_class_pe": [ "Increased Large Intestinal Motility [PE]", "Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]" ], "pharm_class_moa": [ "Osmotic Activity [MoA]" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CHLORINE DIOXIDE", "activesubstance": { "activesubstancename": "CHLORINE DIOXIDE" }, "openfda": { "brand_name": [ "PURE O2-S F" ], "generic_name": [ "CHLORINE DIOXIDE" ], "manufacturer_name": [ "Pure O2" ], "product_ndc": [ "75124-0014", "75124-0001" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "CHLORINE DIOXIDE" ], "spl_id": [ "33e25ea9-f6c4-787b-e063-6294a90a3fad", "adfeccac-a851-8cb6-e053-2995a90ac488" ], "spl_set_id": [ "33e26932-15f7-8304-e063-6294a90a7324", "a390128a-0331-0afa-e053-2a95a90a97bc" ], "package_ndc": [ "75124-0014-1", "75124-0001-1" ], "unii": [ "8061YMS4RM" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VITAMINS", "activesubstance": { "activesubstancename": "VITAMINS" } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20220904" } } } }