{ "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": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 43064 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10012245", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140314", "receiptdateformat": "102", "receiptdate": "20140314", "fulfillexpeditecriteria": "1", "companynumb": "2013SP005565", "duplicate": "1", "reportduplicate": { "duplicatesource": "STRIDES", "duplicatenumb": "2013SP005565" }, "primarysource": { "reportercountry": "US" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "65", "patientonsetageunit": "801", "patientweight": "42.3", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Cellulitis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Pyrexia", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "SODIUM CHLORIDE", "drugstartdateformat": "602", "drugstartdate": "2011", "openfda": { "application_number": [ "NDA018897", "NDA019635", "ANDA201833", "M018", "ANDA213688", "ANDA207310", "NDA020178", "NDA019319", "ANDA207956", "ANDA208122", "ANDA209476", "NDA018314", "505G(a)(3)", "M022", "part349", "NDA202832", "NDA021569", "M012", "NDA018800", "ANDA212248", "ANDA078177", "NDA017464", "ANDA088912", "NDA016733", "NDA018016", "NDA016677", "ANDA206171", "NDA018803", "NDA017867", "M016", "NDA018090", "NDA016366", "NDA017427", "ANDA212070", "ANDA217796", "NDA019465", "ANDA211968", "NDA019022", "ANDA088911" ], "brand_name": [ "SODIUM CHLORIDE", "CVS HEALTH STERILE SALINE MIST", "HYPERTONIC SALINE", "LICEFREEE EVERYDAY", "SALINE CLEANING", "OHTRUST ARTIFICAL EYEDROP", "AQUA MARINA", "NATRUM MURIATICUM", "0.9 PERCENT SALINE SOLUTION", "STERILE SALINE MIST WALGREENS", "WALGREENS", "ARTIFICIAL EYEDROP", "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", "SODIUM CHLORIDE 1 GRAM", "D-129", "WORAFY GENTLE EYE WASH", "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", "SODIUM CHLORODE HYPERTONICITY OPHTHALMIC SOLUTION", "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", "EXTRA STRENGHT SALINE MIST RITE AID", "NORMAL SALT", "HYDRA NEB", "NAT MUR", "SINUCLEANSE STERILE SALINE MIST", "SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC", "ALTACHLORE SODIUM CHLORIDE HYPERTONICITY", "STERILE SALINE KIDS MIST SINUCLEANSE BREATHE", "NASOCALM", "NAT MUR 6X", "NATURAL LIQUIDMINERALSPRAY", "NATURAL LIQUIDMINERAL", "BURBLE", "0.9%SALINE", "SODIUM CHLORIDE OPHTHALMIC 5 PERCENT HYPERTONICITY EYE", "NASAL RINES SALT", "NATURAL LIQUIDGROUND WATER SALT", "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. 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SOFTENER LAXATIVE", "EXCHANGE SELECT STOOL SOFTENER", "STOOL SOFTENER EXTRA STRENGTH", "DOCUSATE MINI ENEMA", "GOOD SENSE STOOL SOFTENER", "DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE", "DOCUSATE SODIUM 100MG", "PREFERRED STOOL SOFTENER", "COLACE EXTRA STRENGTH STOOL SOFTNER", "STOOL SOFTENER LAXATIVE EXTRA STRENGTH", "ENEMEEZ", "WALGREENS STOOL SOFTENER FRUIT PUNCH", "FLEET", "GOOD NEIGHBOR STOOL SOFTENER LAXATIVE", "PHILLIPS STOOL SOFTENER BULK DOCUSATE", "BASIC CARE STOOL SOFTENER", "STOOL SOFTENER REGULAR STRENGTH", "DOK", "PREFERRED STOOL SOFTENER LAXATIVE", "QUALITY CHOICE STOOL SOFTENER", "FEVIA CONSTIPATION CONTROL", "STOOL SOFTENER DOCUSATE SODIUM", "CVS STOOL SOFTENER FRUIT PUNCH", "GOOD NEIGHBOR STOOL SOFTENER", "KROGER STOOL SOFTENER FRUIT PUNCH", "DULCOLAX PINK STOOL SOFTENER", "QUALITY CHOICE STOOL SOFTENER LAXATIVE", "TOPCARE STOOL SOFTENER LAXATIVE", "DOCUSATE SODIUM 50 MG", "PEDIA-LAX", "DOCUSATE SODIUM 50MG SOFTGEL (RED)", "DOCUSATE SODIUM SOFTGELS 50MG (DYE FREE)" ], "generic_name": [ "DOCUSATE SODIUM", "DOCUSATE SODIUM 100MG" ], "manufacturer_name": [ "Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.", "TARGET Corporation", "United Natural Foods, Inc. dba UNFI", "EQUATE (Wal-Mart Stores, Inc.) 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Perrigo Company", "Geri-Care Pharmaceutical Corp", "Care One (Retail Business Services, LLC.)", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.", "Walgreen Co.", "Reese Pharmaceutical Co", "BJWC (Berkley & Jensen / BJ's)", "Atlantis Consumer Healthcare Inc.", "WALMART INC. (see also Equate)", "Quest Products, LLC", "WALGREENS CO.", "Strategic Sourcing Services LLC", "MEIJER, INC.", "The Kroger Co.", "Allegiant Health", "Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd", "RMT HEALTH LLC", "C.B. Fleet Company, Inc.", "AmerisourceBergen Drug Corp", "Bayer HealthCare LLC.", "Amazon.com Services LLC", "Sam's West, Inc", "MAJOR PHARMACEUTICALS", "Sam's West Inc", "Publix Supermarkets, Inc.", "Amerisource Bergen", "STRATEGIC SOURCING SERVICES LLC", "Chain Drug Marketing Association", "VIVUNT PHARMA LLC", "Magno-Humphries, Inc.", "APNAR PHARMA LP", "CVS PHARMACY, INC", "Meijer Distribution Inc.", "Pharbest Pharmaceuticals, Inc.", "Best Choice (Valu Merchandisers Company)", "Costco Wholesale", "American Health Packaging", "QUALITY CHOICE (Chain Drug Marketing Association)", "Geri-Care Pharmaceuticals, Corp", "CARDINAL HEALTH 110, LLC. 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