{"id":"bacteriostatic-sodium-chloride-0-9-in-plastic-container","rwe":[{"pmid":"41903110","year":"2026","title":"Deletion of Cab39 adaptors results in KS-WNK1 independent accumulation of SPAK in biomolecular condensates.","finding":"","journal":"American journal of physiology. Renal physiology","studyType":"Clinical Study"},{"pmid":"41901155","year":"2026","title":"Agreement Between an Artificial Intelligence-Based Meal Image Recognition System and the Weighed Dietary Record for Estimating Energy and Nutrient Intakes.","finding":"","journal":"Nutrients","studyType":"Clinical Study"},{"pmid":"41900657","year":"2026","title":"Alkali-Equivalent-Dependent Dual Role of Sodium Chloride in Alkali-Activated Slag Cement: From Synergistic Activator to Competitive Inhibitor.","finding":"","journal":"Materials (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41898381","year":"2026","title":"Correction: Castagna et al. Sodium Chloride Cotransporter in Hypertension. Biomedicines 2024, 12, 2580.","finding":"","journal":"Biomedicines","studyType":"Clinical Study"},{"pmid":"41895942","year":"2026","title":"The contribution of polysaccharides to the foaming and emulsifying properties of aquafaba.","finding":"","journal":"Food research international (Ottawa, Ont.)","studyType":"Clinical Study"}],"_fda":{"id":"8e1ca6c4-2e03-4c2f-b69b-be57bb896c1c","set_id":"009bef3c-e8ac-46be-b564-a2556adf0081","openfda":{"unii":["451W47IQ8X"],"route":["IRRIGATION"],"rxcui":["486515"],"spl_id":["8e1ca6c4-2e03-4c2f-b69b-be57bb896c1c"],"brand_name":["Sodium Chloride"],"spl_set_id":["009bef3c-e8ac-46be-b564-a2556adf0081"],"package_ndc":["0990-7972-08"],"product_ndc":["0990-7972"],"generic_name":["SODIUM CHLORIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["SODIUM CHLORIDE"],"manufacturer_name":["ICU Medical Inc."],"application_number":["NDA018314"],"is_original_packager":[true]},"version":"11","warnings":["WARNINGS FOR IRRIGATION ONLY. NOT FOR INJECTION. Entry of a hypotonic solution into the circulation may cause hemolysis. Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, each of these irrigations must be regarded as a systemic drug. Absorption of large amounts can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions. Do not heat over 66° C (150° F)."],"overdosage":["OVERDOSAGE In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS , PRECAUTIONS and ADVERSE REACTIONS ."],"description":["DESCRIPTION This product is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, rinsing, dilution and cell washing purposes. Each 100 mL of 0.9% Sodium Chloride Irrigation, USP contains: Sodium chloride 900 mg. pH 5.6 (4.5 — 7.0). The solution is isotonic (308 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Na + 154; Cl¯ 154. This irrigation solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose, short procedure irrigation, or cell washing fluid. When smaller volumes are required the unused portion should be discarded. It may be classified as a sterile irrigant, rinse, diluent, cell wash and pharmaceutical vehicle. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Water for Injection, USP is chemically designated H 2 O. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period."],"precautions":["PRECAUTIONS Do not use for irrigation that may result in absorption into the blood. Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities, wounds and urethral catheters or for wetting dressings that come in contact with body tissues or for cell washing techniques. The flexible container is designed for use with nonvented irrigation sets or nonvented sets for cell washing harvesting systems. When used for irrigation via irrigation equipment, the administration set should be attached promptly. Unused portions should be discarded and a fresh container used for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral catheters, a separate container should be used for each patient. When used for cell washing, the nonvented set should be attached promptly. The three liter container may be used to dispense new aliquots of washing solution for each wash cycle for the same patient. However, unused portions should be discarded and a separate container should be used for each patient and each start-up procedure. Do not administer unless solution is clear, seal is intact and container is undamaged. Discard unused portion. Carcinogenesis, Mutagenesis, Impairment of Fertility : Studies with Sodium Chloride Irrigation, USP have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Nursing Mothers: Caution should be exercised when Sodium Chloride Irrigation, USP is administered to a nursing woman. Pregnancy: Teratogenic Effects. Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Chloride Irrigation, USP. It is also not known whether Sodium Chloride Irrigation, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This solution should be given to a pregnant woman only if clearly needed. Pediatric Use: Safety and effectiveness of Sodium Chloride irrigation solution in pediatric patients have not been established by adequate and well-controlled trials. However, the use of Sodium Chloride irrigation solution in the pediatric population is referenced in the medical literature. The Warnings , Precautions , and Adverse Reactions identified in the label should be observed in the pediatric population. Geriatric Use: An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. This drug is known to be substantially secreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function."],"how_supplied":["HOW SUPPLIED 0.9% Sodium Chloride Irrigation, USP is supplied in a single-dose 3000 mL flexible irrigation container (NDC No. 0409-7972-08 / 0990-7972-08). ICU Medical is transitioning NDC codes from \"0409\" to a \"0990\" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: June, 2018 EN-4661 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA"],"effective_time":"20251031","adverse_reactions":["ADVERSE REACTIONS Possible adverse effects arising from the irrigation of body cavities, tissues, cells or indwelling catheters and tubes are usually avoidable when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, discontinue the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary."],"contraindications":["CONTRAINDICATIONS NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY This irrigation solution exerts a mechanical cleansing action for sterile irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes and for washing, rinsing or soaking surgical dressings, instruments and laboratory specimens. It also serves as a diluent or vehicle for drugs used for irrigation or other pharmaceutical preparations. 0.9% Sodium Chloride Irrigation, USP provides an isotonic saline irrigation identical in composition with 0.9% Sodium Chloride Injection, USP (normal saline). 0.9% Sodium Chloride Irrigation, USP is considered generally compatible with living tissues and organs. Sodium chloride in water dissociates to provide sodium (Na + ) and chloride (Cl¯) ions. Sodium (Na + ) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl¯) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na + ) and chloride (Cl¯) are largely under the control of the kidney which maintains a balance between intake and output. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na + ) plays a major role in maintaining physiologic equilibrium."],"indications_and_usage":["INDICATIONS AND USAGE This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment)."],"spl_unclassified_section":["FOR ALL GENERAL IRRIGATION, RINSING, DILUTION AND CELL WASHING PURPOSES Not For Injection By Usual Parenteral Routes Flexible Irrigation Container Rx only"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a diluent or vehicle for other drugs, the manufacturer's recommendations should be followed. For use in cell washing, the manufacturer's recommendations for blood salvaging and red cell processing should be followed. Drug Interactions Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS ."],"spl_product_data_elements":["Sodium Chloride SODIUM CHLORIDE SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 3000 mL Bag Label 3000 mL NDC 0990-7972-08 0.9% SODIUM CHLORIDE Irrigation , USP EACH 100 mL CONTAINS SODIUM CHLORIDE, 900 mg. pH 5.6 (4.5 to 7.0) 308 mOsmol/LITER (CALC.) STERILE, NONPYROGENIC. INDICATIONS: ISOTONIC SOLUTION FOR IRRIGATION. CONTRAINDICATIONS: NOT FOR INJECTION. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. WARNINGS: DO NOT HEAT OVER 66°C (150°F). STORE AT 20 TO 25°C (68 TO 77°F). [SEE USP CONTROLLED ROOM TEMPERATURE.] PROTECT FROM FREEZING. SINGLE-DOSE CONTAINER. CONTAINS NO BACTERIOSTAT. DISCARD UNUSED PORTION. USE ASEPTIC TECHNIQUE. DOSAGE AND ADMINISTRATION: AS DIRECTED BY PHYSICIAN. RX ONLY 3 V CONTAINS DEHP icumedical IM-4376 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA PRINCIPAL DISPLAY PANEL - 3000 mL Bag Label","PRINCIPAL DISPLAY PANEL - 3000 mL Bag Overwrap TO OPEN TEAR AT NOTCH 2 HDPE DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY. IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED. RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE HEAT. PROTECT FROM FREEZING. SEE INSERT. 98-4321-R14-3/98 Principal Display Panel - 3000 mL Bag Overwrap"]},"tags":[{"label":"sodium chloride","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A12CA01","category":"atc"},{"label":"Nasal","category":"route"},{"label":"Intrathecal","category":"route"},{"label":"Intravascular","category":"route"},{"label":"Aerosol","category":"form"},{"label":"Cloth","category":"form"},{"label":"Gel","category":"form"},{"label":"Granule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Baxter Hlthcare","category":"company"},{"label":"Approved 1960s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"17033 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"16498 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"13555 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"13178 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"13073 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"12258 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"11126 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"10774 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"10655 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"10475 reports"}],"commonSideEffects":[{"effect":"COVID-19","drugRate":"19.5%","placeboRate":"","totalAtRisk":36749,"totalAffected":7154,"trialsReporting":2},{"effect":"Headache","drugRate":"12.4%","placeboRate":"","totalAtRisk":36749,"totalAffected":4557,"trialsReporting":2},{"effect":"Fatigue","drugRate":"10.3%","placeboRate":"","totalAtRisk":36749,"totalAffected":3790,"trialsReporting":2},{"effect":"Injection site pain","drugRate":"10.3%","placeboRate":"","totalAtRisk":36749,"totalAffected":3789,"trialsReporting":2},{"effect":"Chills","drugRate":"10.2%","placeboRate":"","totalAtRisk":21587,"totalAffected":2208,"trialsReporting":1},{"effect":"Pain","drugRate":"8.6%","placeboRate":"","totalAtRisk":21587,"totalAffected":1857,"trialsReporting":1},{"effect":"Myalgia","drugRate":"7.5%","placeboRate":"","totalAtRisk":21587,"totalAffected":1622,"trialsReporting":1},{"effect":"Pyrexia","drugRate":"5.4%","placeboRate":"","totalAtRisk":21587,"totalAffected":1174,"trialsReporting":1},{"effect":"Upper respiratory tract infection","drugRate":"2.4%","placeboRate":"","totalAtRisk":15162,"totalAffected":361,"trialsReporting":1}],"contraindications":["Not for injection by usual parenteral routes","Should not be used for irrigation during electrosurgical procedures"],"specialPopulations":{"Lactation":"The components of DELFLEX solutions are excreted in human milk. Appropriate administration of DELFEX solutions with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to harm nursing infant.","Pregnancy":"While there are no adequate and well controlled studies in pregnant women, appropriate administration of DELFLEX with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm.","Geriatric use":"Clinical studies of Ringers Irrigation have not been performed to determine whether patients over 65 years respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."}},"company":"Baxter","patents":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Sodium Chloride","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:48:55.125080+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Sodium Chloride","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:49:07.455303+00:00"},"mechanism":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:28:35.312426+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:49:05.551480+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:48:53.765172+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Sodium Chloride","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:49:06.395679+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:48:51.441218+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:48:51.441263+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:49:08.533176+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200574/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:49:07.337436+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA018314","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:48:51.441268+00:00"}},"allNames":"plegisol in plastic container","synonyms":["sodium chloride"],"timeline":[{"date":"1965-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from HOSPIRA to Baxter Hlthcare"},{"date":"1965-12-16","type":"positive","source":"DrugCentral","milestone":"FDA approval (Hospira)"},{"date":"1982-02-19","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 0.45% In Plastic Container approved — 450MG/100ML"},{"date":"1982-10-29","type":"positive","source":"FDA Orange Book","milestone":"Bacteriostatic Sodium Chloride 0.9% In Plastic Container approved — 90MG/10ML (9MG/ML)"},{"date":"1983-11-01","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 3% In Plastic Container approved — 3GM/100ML"},{"date":"1984-07-20","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 14.6% approved — 50MEQ/20ML (2.5MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"1985-04-30","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 0.9% In Plastic Container approved — 180MG/20ML (9MG/ML)"},{"date":"1985-05-17","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 0.9% In Sterile Plastic Container approved — 900MG/100ML"},{"date":"1985-07-15","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 0.9% In Plastic Container approved — 450MG/50ML (9MG/ML)"},{"date":"1985-09-17","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 0.9% In Plastic Container approved — 900MG/100ML"},{"date":"1987-04-22","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 23.4% In Plastic Container approved — 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"1988-06-08","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 0.45% In Plastic Container approved — 450MG/100ML"},{"date":"1992-09-03","type":"positive","source":"FDA Orange Book","milestone":"Broncho Saline approved — 0.9%"},{"date":"1992-12-07","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 0.9% In Plastic Container approved — 450MG/50ML (9MG/ML)"},{"date":"1999-04-01","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 0.9% In Plastic Container approved — 360MG/40ML (9MG/ML)"},{"date":"2006-07-27","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 0.9% In Plastic Container approved — 1.125GM/125ML (9MG/ML)"},{"date":"2007-04-12","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 5 manufacturers approved"},{"date":"2012-01-06","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 0.9% approved — 9MG/ML (9MG/ML)"},{"date":"2015-01-22","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 0.9% In Plastic Container approved — 18MG/2ML (9MG/ML)"},{"date":"2016-08-08","type":"positive","source":"FDA Orange Book","milestone":"Sodium Chloride 0.9% approved — 90MG/10ML (9MG/ML)"}],"aiSummary":"Sodium Chloride Irrigation, USP is a sterile, nonpyrogenic isotonic saline solution indicated for general irrigation, washing, rinsing, and dilution purposes including blood cell washing. The solution provides sodium and chloride ions essential for maintaining fluid and electrolyte balance and is considered compatible with living tissues and organs. Primary contraindications include prohibition from injection by usual parenteral routes and avoidance during electrosurgical procedures. The product serves as a mechanical cleansing agent and vehicle for pharmaceutical preparations in surgical and clinical settings.","brandName":"Plegisol In Plastic Container","mechanism":{"target":"Not specified","novelty":"First-in-class","modality":"Irrigation solution","drugClass":"Electrolyte solution","explanation":"Sodium Chloride Irrigation, USP is an isotonic saline solution identical in composition to 0.9% Sodium Chloride Injection, USP (normal saline). The solution dissociates to provide sodium (Na+) and chloride (Cl−) ions. Sodium is the principal cation of extracellular fluid and plays a large role in therapy of fluid and electrolyte disturbances, while chloride has an integral role in buffering action during oxygen and carbon dioxide exchange in red blood cells.\n\nThe solution is considered generally compatible with living tissues and organs. Distribution and excretion of sodium and chloride are largely controlled by the kidney, which maintains balance between intake and output. Water, an essential constituent of all body tissues accounting for approximately 70% of total body weight, is maintained through various regulatory mechanisms, with sodium playing a major role in maintaining physiologic equilibrium.","oneSentence":"Provides isotonic saline irrigation with mechanical cleansing action for sterile irrigation of body cavities, tissues, wounds, and surgical equipment.","technicalDetail":"Plegisol In Plastic Container (Sodium Chloride) is a solution of sodium chloride (NaCl) in water, providing a source of essential electrolytes for various medical purposes, including fluid and electrolyte replenishment."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Sodium_chloride","title":"Sodium chloride","extract":"Sodium chloride, commonly known as table salt, is an ionic compound with the chemical formula NaCl, representing a 1:1 ratio of sodium and chloride ions. It is transparent or translucent, brittle, hygroscopic, and occurs as the mineral halite. In its edible form, it is commonly used as a condiment and food preservative. Large quantities of sodium chloride are used in many industrial processes, and it is a major source of sodium and chlorine compounds used as feedstocks for further chemical syntheses. Another major application of sodium chloride is de-icing of roadways in sub-freezing weather."},"commercial":{"launchDate":"1965","_launchSource":"DrugCentral (FDA 1965-12-16, HOSPIRA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4198","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Sodium%20Chloride","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Sodium Chloride","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Sodium_chloride","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T01:46:47.088007","_validation":{"fieldsValidated":4,"lastValidatedAt":"2026-04-20T08:28:40.055722+00:00","fieldsConflicting":0,"overallConfidence":0.95},"competitors":[{"drugName":"sodium sulfate","drugSlug":"sodium-sulfate","fdaApproval":"1986-04-30","relationship":"same-class"}],"genericName":"sodium chloride","indications":{"approved":[],"offLabel":[],"pipeline":[]},"currentOwner":"Baxter Hlthcare","drugCategory":"established","patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"sodium-sulfate","brandName":"sodium sulfate","genericName":"sodium sulfate","approvalYear":"1986","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT02466971","phase":"PHASE3","title":"Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2016-05-10","conditions":["Advanced Vaginal Adenocarcinoma","Advanced Vaginal Adenosquamous Carcinoma","Advanced Vaginal Squamous Cell Carcinoma","Cervical Adenocarcinoma","Cervical Adenosquamous Carcinoma","Cervical Squamous Cell Carcinoma","Stage IB2 Cervical Cancer AJCC v6 and v7","Stage II Cervical Cancer AJCC v7","Stage II Vaginal Cancer AJCC v6 and v7","Stage IIA Cervical Cancer AJCC v7","Stage IIB Cervical Cancer AJCC v6 and v7","Stage III Vaginal Cancer AJCC v6 and v7","Stage IIIB Cervical Cancer AJCC v6 and v7","Stage IV Vaginal Cancer AJCC v6 and v7","Stage IVA Cervical Cancer AJCC v6 and v7","Stage IVA Vaginal Cancer AJCC v6 and v7","Unresectable Vaginal Carcinoma","Vaginal Adenocarcinoma","Vaginal Adenosquamous Carcinoma","Vaginal Carcinoma","Vaginal Squamous Cell Carcinoma, Not Otherwise Specified"],"enrollment":450,"completionDate":"2026-07-14"},{"nctId":"NCT04491942","phase":"PHASE1","title":"Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2021-08-25","conditions":["Advanced Bile Duct Carcinoma","Advanced Breast Carcinoma","Advanced Cervical Carcinoma","Advanced Endometrial Carcinoma","Advanced Esophageal Carcinoma","Advanced Gastric Carcinoma","Advanced Head and Neck Carcinoma","Advanced Lung Non-Small Cell Carcinoma","Advanced Lung Small Cell Carcinoma","Advanced Malignant Solid Neoplasm","Advanced Ovarian Carcinoma","Advanced Penile Carcinoma","Advanced Pleural Malignant Mesothelioma","Advanced Urothelial Carcinoma","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Stage III Cervical Cancer AJCC v8","Stage III Distal Bile Duct Cancer AJCC v8","Stage III Intrahepatic Bile 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