{"id":"fluoride-ion","_fda":{"id":"37336c01-148c-42b0-82b0-aaaf922e1fd1","set_id":"bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a8","openfda":{"unii":["8ZYQ1474W7"],"route":["TOPICAL"],"rxcui":["416783"],"spl_id":["37336c01-148c-42b0-82b0-aaaf922e1fd1"],"brand_name":["ACT Anticavity Fluoride Kids Wild Watermelon"],"spl_set_id":["bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a8"],"package_ndc":["41167-0924-2"],"product_ndc":["41167-0924"],"generic_name":["SODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION)"],"product_type":["HUMAN OTC DRUG"],"substance_name":["SODIUM FLUORIDE"],"manufacturer_name":["Chattem, Inc."],"application_number":["M021"],"is_original_packager":[true]},"purpose":["Purpose Anticavity"],"version":"6","warnings":["Warnings Keep out of reach of children under 6 years of age . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"effective_time":"20260112","active_ingredient":["Active i ngredient Sodium fluoride 0.24% (0.14% w/v fluoride ion)"],"inactive_ingredient":["Inactive ingredients water, sorbitol, hydrated silica, hydroxyethylcellulose, flavor, sucralose, benzoic acid, sodium saccharin, potassium hydroxide, sodium benzoate, dipotassium glycyrrhizate, sodium lauryl sulfate, yellow 5, green 3"],"indications_and_usage":["Use ■ aids in the prevention of dental cavities"],"spl_unclassified_section":["ACT Kids Anticavity Fluoride Toothpaste ( Wild Watermelon ) Drug Facts","Other information ■ contains FD&C yellow no. 5 (tartrazine) as a color additive"],"dosage_and_administration":["Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor children 2 to 6 years of age instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision. children under 2 years of age do not use unless directed by a dentist or doctor"],"spl_product_data_elements":["ACT Anticavity Fluoride Kids Wild Watermelon sodium fluoride 0.24 (0.14 w/v fluoride ion) SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA SUCRALOSE BENZOIC ACID SACCHARIN SODIUM POTASSIUM HYDROXIDE SODIUM BENZOATE GLYCYRRHIZINATE DIPOTASSIUM SODIUM LAURYL SULFATE FD&C YELLOW NO. 5 FD&C GREEN NO. 3 HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)"],"keep_out_of_reach_of_children":["Keep out of reach of children under 6 years of age . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"dosage_and_administration_table":["<table><col width=\"339\"/><col width=\"339\"/><tbody><tr><td styleCode=\"Toprule Rrule \">adults and children 2 years of age and older</td><td styleCode=\"Toprule Lrule \">brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor</td></tr><tr><td styleCode=\"Toprule Rrule \">children 2 to 6 years of age</td><td styleCode=\"Toprule Lrule \">instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision.</td></tr><tr><td styleCode=\"Toprule Rrule \">children under 2 years of age</td><td styleCode=\"Toprule Lrule \">do not use unless directed by a dentist or doctor</td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL ACT Kids wild water- melon NET WT 4.6 oz (130 g) PRINCIPAL DISPLAY PANEL ACT Kids wild water- melon NET WT 4.6 oz (130 g)"]},"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"NO ADVERSE EVENT","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"ORAL MUCOSAL EXFOLIATION","source":"FDA FAERS","actionTaken":"2 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"ORAL DISCOMFORT","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"PARAESTHESIA ORAL","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"PRODUCT PACKAGING ISSUE","source":"FDA FAERS","actionTaken":"1 reports"},{"date":"","signal":"PRODUCT USE ISSUE","source":"FDA FAERS","actionTaken":"1 reports"}]},"_chembl":{"chemblId":"CHEMBL1362","moleculeType":"Small molecule","molecularWeight":"19.00"},"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=FLUORIDE ION","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:19:35.538966+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:19:48.979264+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=FLUORIDE 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(EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:19:50.535523+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M021","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:19:33.218845+00:00"}},"_dailymed":{"setId":"cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49","title":"ACT WHITENING ANTICAVITY GENTLE MINT (SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION)) MOUTHWASH [CHATTEM, INC.]"},"_scrapedAt":"2026-03-28T01:47:03.277Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:19:53.287679+00:00","fieldsConflicting":0,"overallConfidence":0.95},"trialDetails":[{"nctId":"NCT06166849","phase":"NA","title":"Clinical Evaluation of an Experimental Remineralization Product","status":"COMPLETED","sponsor":"Ivoclar Vivadent AG","startDate":"2023-03-28","conditions":"White Spot 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