{"id":"mouth-rinse","_fda":{"id":"46e1e8df-948a-b1cc-e063-6394a90a1521","set_id":"c110cf06-98ad-b30c-e053-2995a90a8e53","openfda":{"upc":["0370275936169"],"unii":["D9OM4SK49P"],"route":["DENTAL"],"rxcui":["1599135"],"spl_id":["46e1e8df-948a-b1cc-e063-6394a90a1521"],"brand_name":["TheraStom"],"spl_set_id":["c110cf06-98ad-b30c-e053-2995a90a8e53"],"package_ndc":["70275-936-16"],"product_ndc":["70275-936"],"generic_name":["ANTIGINGIVITIS/ANTIPLAQUE MOUTH RINSE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["CETYLPYRIDINIUM CHLORIDE"],"manufacturer_name":["Forward Science Technologies LLC"],"is_original_packager":[true]},"purpose":["Purpose Antigingivitis/Antiplaque"],"version":"4","warnings":["Warnings Stop use and ask a dentist if: • Gingivitis, bleeding, or redness persists for more than 2 weeks • You have painful or swollen gums, pus from the gum line, loose teeth, or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease."],"effective_time":"20251226","active_ingredient":["Active Ingredient Cetylpyridinium Chloride 0.075%"],"inactive_ingredient":["Inactive Ingredients Calcium Disodium EDTA, Flavor (Peppermint, Eucalyptus, Pink Grapefruit), Glycerin, PEG-40, Propylene Glycol, Water, Xylitol, Zinc Gluconate"],"instructions_for_use":["Directions • Adults and children 12 years or older: Vigorously swish 20 ml (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. • Children 6 years to under 12 years of age: supervise use • Children under 6 years of age: do not use"],"indications_and_usage":["Use(s) • Helps control plaque that leads to bleeding gums. • Helps prevent gingivitis, an early form of gum disease ."],"information_for_patients":["Other information This rinse is not intended to replace brushing or flossing"],"dosage_and_administration":["Dosage Vigorously swish 20 ml (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out."],"spl_product_data_elements":["TheraStom antigingivitis/antiplaque mouth rinse PROPYLENE GLYCOL EUCALYPTUS OIL POLYOXYL 40 HYDROGENATED CASTOR OIL WATER EDETATE CALCIUM DISODIUM GLYCERIN CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM GRAPEFRUIT OIL XYLITOL ZINC GLUCONATE PEPPERMINT OIL"],"keep_out_of_reach_of_children":["Keep out of reach of children Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["therastombottlelabel"]},"safety":{"boxedWarnings":[]},"_chembl":{"chemblId":"CHEMBL55400","moleculeType":"Small molecule","molecularWeight":"209.25"},"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=mouth rinse","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T06:49:24.672383+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T06:49:52.576725+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T06:49:31.497053+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=mouth rinse","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T06:49:31.837861+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:49:23.533521+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:49:43.847471+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T06:49:23.533551+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: DNA disrupting agent","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T06:49:33.056661+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL55400/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T06:49:32.710044+00:00"}},"_dailymed":{"setId":"5b9c19a1-e3c0-4bed-92dd-8bff48477e2e","title":"ANTISEPTIC MOUTH RINSE (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [NICE-PAK PRODUCTS, LLC]"},"aiSummary":"Mouth rinse is a liquid held in the mouth to be swirled around and may be gargled, typically by tilting the head back and bubbling the liquid at the back of the mouth. It has been studied as a treatment for various conditions, including gingivitis, head and neck cancer, and postoperative complications, and its mechanism is classified as a DNA disrupting agent.","_scrapedAt":"2026-03-28T02:43:36.824Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T06:49:52.576826+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"id":"mouth-rinse-control-of-plaque-leading-to-b","name":"Control of plaque leading to bleeding gums","dosing":null,"approvals":[],"diseaseId":"","eligibility":"General population","pivotalTrial":null,"restrictions":[],"patientPopulation":"General population","diagnosticRequired":null,"brandNameForIndication":""},{"id":"mouth-rinse-prevention-of-gingivitis","name":"Prevention of gingivitis","dosing":null,"approvals":[],"diseaseId":"","eligibility":"General population","pivotalTrial":null,"restrictions":[],"patientPopulation":"General 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