{"id":"ascorbic-acid","rwe":[],"_fda":{"id":"41b76910-3e17-3254-e063-6294a90adb54","set_id":"003181d4-5412-4ffe-b99d-880f2010e3ad","openfda":{"nui":["N0000193618","M0001797","M0022788","N0000175950"],"unii":["PQ6CK8PD0R","8ZYQ1474W7","81G40H8B0T","9VU1KI44GP"],"route":["ORAL"],"rxcui":["1365980"],"spl_id":["41b76910-3e17-3254-e063-6294a90adb54"],"brand_name":["Tri-Vite Drops with Fluoride"],"spl_set_id":["003181d4-5412-4ffe-b99d-880f2010e3ad"],"package_ndc":["58657-323-50"],"product_ndc":["58657-323"],"generic_name":["ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A AND VITAMIN D"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Ascorbic Acid [CS]","Vitamin A [CS]"],"substance_name":["ASCORBIC ACID","SODIUM FLUORIDE","VITAMIN A","VITAMIN D"],"pharm_class_epc":["Vitamin C [EPC]","Vitamin A [EPC]"],"manufacturer_name":["Method Pharmaceuticals, LLC"],"is_original_packager":[true]},"version":"7","warnings":["WARNINGS As in the case of all medications, keep out of reach of children."],"references":["REFERENCES 1. Brudevoid F, McCann HG: Fluoride and caries control - Mechanism of action, in Nizel AE (ed): The Science of Nutrition and its Application in Clinical Dentistry. Philadelphia, WB Saunders Co, 1966, pp 331-347. 2. American Academy of Pediatrics Committee on Nutrition: Fluoride supplementation, Pediatrics 1986; 77:758. 3. American Dental Association Council on Dental Therapeutics: Accepted Dental Therapeutics , ed 38, Chicago, 1979, p321. 4. Hennon DK, Stookey GK, Muhler JC: The clinical anticariogenic effectiveness of supplementary fluoride-vitamin preparations - Results at the end of three years. J Dent Children 1966; 33 January: 3-12. 5. Hennon DK, Stookey GK, Muhler JC: The clinical anticariogenic effectiveness of supplementary fluoride-vitamin preparations - Results at the end of four years. J Dent Children 1967; 34 November; 439- 443. 6. Hennon DK, Stookey GK, Muhler JC: The clinical anticariogenic effectiveness of supplementary fluoride-vitamin preparations - Results at the end of five and a half years. Phar and Ther in Dent 1970; 1:1. 7. Hennon DK, Stookey GK, Beiswanger BB: Fluoride-vitamin supplements: Effects on dental caries and fluorosis when used in areas with suboptimum fluoride in the water supply. J Am Dent Assoc 1977; 95-965 Distributed by: Method Pharmaceuticals, LLC Fort Worth, TX 76118 1-877-250-3427 Rev. 07/2018"],"precautions":["PRECAUTIONS The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When prescribing vitamin fluoride products: 1. Determine the fluoride content of the drinking water. 2. Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste. 3. Periodically check to make sure that the child does not develop significant dental fluorosis. Tri-Vite Drops with Fluoride 0.25 mg should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50 mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.) Important Considerations When Using Dosage Schedule: • If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department. • All sources of fluoride should be evaluated with a thorough fluoride history. Patient exposure to multiple water sources can make proper prescribing complex. • Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth. • Fluoride supplements require long-term compliance on a daily basis."],"effective_time":"20251021","adverse_reactions":["ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation: Three stages of fluoride deposition in tooth enamel can be distinguished: 1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed. 2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted. 3. After eruption, the surface enamel acquires fluoride from water, food, supplementary fluoride and smaller amounts from saliva. eq"],"indications_and_usage":["INDICATIONS AND USAGE Supplementation of the diet with vitamins A, C and D. Tri-Vite Drops with Fluoride 0.25 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Tri-Vite Drops with Fluoride 0.25 mg (See Dosage and Administration ). Tri-Vite Drops with Fluoride 0.25 mg supply significant amounts of vitamins A, C and D to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain essential vitamins and fluoride."],"spl_unclassified_section":["Supplement Facts Serving Size: 1.0 mL Amount Per Serving Percentage of U.S. Recommended Daily Allowance Each 1.0 mL supplies: Children 6 mos - 4 years old Vitamin A 1500 IU 60% Vitamin C 35 mg 88% Vitamin D 400 IU 100% Fluoride (as Sodium Fluoride) 0.25 mg * * Daily Value not established See INDICATIONS AND USAGE section for use by children 6 months to 6 years of age. This product does not contain the essential vitamin folic acid. Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. Does not contain folic acid. Other ingredients: caramel color, cherry flavor, EDTA, glycerin, polysorbate 80, potassium sorbate, purified water, sodium benzoate, sorbitol solution, sucralose.","RECOMMENDED STORAGE Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). After opening, store away from direct light. Close tightly after each use. Occasional deepening of color has no significant effect on vitamin potency. REFRIGERATION IS NOT REQUIRED. SHAKE WELL."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION 1.0 mL daily or as directed by physician. May be dropped directly into the mouth with dropper; or mixed with cereal, fruit juice or other food. Tri-Vite Drops with Fluoride 0.25 mg is available in 50 mL bottles with accompanying calibrated dropper."],"spl_product_data_elements":["Tri-Vite Drops with Fluoride ASCORBIC ACID, SODIUM FLUORIDE, VITAMIN A and VITAMIN D EDETIC ACID GLYCERIN POLYSORBATE 80 POTASSIUM SORBATE WATER SODIUM BENZOATE SORBITOL SUCRALOSE VITAMIN A VITAMIN A ASCORBIC ACID ASCORBIC ACID VITAMIN D VITAMIN D SODIUM FLUORIDE FLUORIDE ION caramel color"],"spl_unclassified_section_table":["<table><col width=\"180\"/><col width=\"132\"/><col width=\"312\"/><tbody><tr><td colspan=\"2\"><content styleCode=\"bold\">Amount Per Serving</content></td><td><content styleCode=\"bold\">Percentage of</content> <content styleCode=\"bold\">U.S. Recommended</content><content styleCode=\"bold\"> Daily Allowance </content></td></tr><tr><td colspan=\"2\"><content styleCode=\"bold\">Each 1.0 mL supplies:</content></td><td><content styleCode=\"bold\">Children 6 mos - 4 years old</content></td></tr><tr><td>Vitamin A</td><td align=\"center\">1500 IU</td><td>60%</td></tr><tr><td>Vitamin C</td><td align=\"center\">35 mg</td><td>88%</td></tr><tr><td>Vitamin D</td><td align=\"center\">400 IU</td><td>100%</td></tr><tr><td>Fluoride (as Sodium Fluoride)</td><td align=\"center\">0.25 mg</td><td>*</td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 58657-323-50 Tri-Vite Drops WITH FLUROIDE 0.25 mg 1.69 FL. OZ. (50 mL) label"]},"tags":[{"label":"Vitamin C","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Tyrosinase","category":"target"},{"label":"TYR","category":"gene"},{"label":"PLOD1","category":"gene"},{"label":"P4HA1","category":"gene"},{"label":"A11GA01","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Active","category":"status"},{"label":"Ascorbic acid deficiency","category":"indication"},{"label":"Breastfeeding (mother)","category":"indication"},{"label":"Antioxidants","category":"pharmacology"},{"label":"Micronutrients","category":"pharmacology"},{"label":"Protective Agents","category":"pharmacology"},{"label":"Vitamins","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"2536 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"2516 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"2304 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"2181 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"2155 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"2048 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"2002 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"1878 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"1670 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"1606 reports"}],"commonSideEffects":[{"effect":"faintness","drugRate":"reported","severity":"mild"},{"effect":"dizziness","drugRate":"reported","severity":"mild"},{"effect":"soreness","drugRate":"reported","severity":"mild"}],"contraindications":["Acute exacerbation of asthma","Acute nephropathy","Acute tuberculosis","Acute vomiting","Allergic rhinitis","Anemia due to enzyme deficiency","Anuria","Arteriosclerosis obliterans","At risk for aspiration","Atrophic gastritis","Blood coagulation disorder","Complete atrioventricular block","Congenital myotonia, autosomal dominant form","Constipation","Dehydration","Dental fluorosis","Denuded skin","Diabetes mellitus","Disease of liver","Diverticular disease","Esophageal dysmotility","Familial hyperkalemic periodic paralysis","Gastrectomy","Gastric retention","Gastroenteritis"],"specialPopulations":{"Pregnancy":"Pregnancy Category C. Animal reproduction studies have not been conducted with Ascorbic Acid Injection. It is also not known whether Ascorbic Acid Injection can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Ascorbic Acid Injection should be given to pregnant woman only if clearly needed.","Geriatric use":"No clinical studies have been performed in patients age 65 and over to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and or concomitant diseases.","Paediatric use":"Safety and effectiveness of this product have not been established in pediatric patients."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ASCORBIC ACID","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:38:35.998135+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:38:41.835217+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:38:35.108677+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ASCORBIC ACID","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:38:42.206522+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:38:32.783143+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:38:32.783176+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:38:32.783181+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":"2026-04-19T23:38:44.420743+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL196/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:38:43.583467+00:00"}},"allNames":"infuvite adult","offLabel":[],"synonyms":["vitamin c","L-Ascorbic acid","ascorbic acid","ascorbic acid (vit C)","sodium ascorbate","calcium ascorbate","ascorbic acid, monosodium salt"],"timeline":[{"date":"2025-08-07","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"}],"aiSummary":"Infuvite Adult (Ascorbic Acid) is a small molecule vitamin C drug developed to target tyrosinase. It is used to treat ascorbic acid deficiency and support breastfeeding mothers. The drug is off-patent and has a high bioavailability of 99%. Key safety considerations include its short half-life of 11.4 hours. Mcguff is the current owner of the drug.","brandName":"Infuvite Adult","ecosystem":[{"indication":"Ascorbic acid deficiency","otherDrugs":[{"name":"calcium pantothenate","slug":"calcium-pantothenate","company":"Hospira"},{"name":"zinc gluconate","slug":"zinc-gluconate","company":""}],"globalPrevalence":null},{"indication":"Breastfeeding (mother)","otherDrugs":[{"name":"calcium phosphate","slug":"calcium-phosphate","company":""},{"name":"doconexent","slug":"doconexent","company":""},{"name":"docusate sodium","slug":"docusate-sodium","company":""},{"name":"eicosapentaenoic acid","slug":"eicosapentaenoic-acid","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Tyrosinase","novelty":"First-in-class","targets":[{"gene":"TYR","source":"DrugCentral","target":"Tyrosinase","protein":"Tyrosinase"},{"gene":"PLOD1","source":"DrugCentral","target":"Procollagen-lysine,2-oxoglutarate 5-dioxygenase 1","protein":"Procollagen-lysine,2-oxoglutarate 5-dioxygenase 1"},{"gene":"P4HA1","source":"DrugCentral","target":"Prolyl 4-hydroxylase subunit alpha-1","protein":"Prolyl 4-hydroxylase subunit alpha-1"},{"gene":"SLC23A1","source":"DrugCentral","target":"Solute carrier family 23 member 1","protein":"Solute carrier family 23 member 1"},{"gene":"SLC23A2","source":"DrugCentral","target":"Solute carrier family 23 member 2","protein":"Solute carrier family 23 member 2"}],"modality":"Small Molecule","drugClass":"Vitamin C [EPC]","explanation":"","oneSentence":"","technicalDetail":"Ascorbic acid, the active ingredient in Infuvite Adult, is a water-soluble vitamin that plays a crucial role in various enzymatic reactions, including the hydroxylation of proline and lysine residues in collagen synthesis."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4072","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ASCORBIC%20ACID","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ASCORBIC ACID","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T08:50:19.673021","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:38:46.089266+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"acetohydroxamic acid","drugSlug":"acetohydroxamic-acid","fdaApproval":"1983-05-31","patentStatus":"Unknown","relationship":"same-target"},{"drugName":"atenolol","drugSlug":"atenolol","fdaApproval":"1981-08-19","genericCount":22,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"dicoumarol","drugSlug":"dicoumarol","fdaApproval":"1944-07-31","relationship":"same-target"}],"genericName":"ascorbic acid","indications":{"approved":[{"name":"Ascorbic acid deficiency","source":"DrugCentral","snomedId":76169001,"regulator":"FDA","eligibility":"no specific eligibility criteria mentioned"},{"name":"Breastfeeding (mother)","source":"DrugCentral","snomedId":413712001,"regulator":"FDA","eligibility":"no specific eligibility criteria mentioned"}],"offLabel":[{"name":"Coronavirus infection","source":"DrugCentral","drugName":"ASCORBIC ACID","evidenceCount":0,"evidenceLevel":"emerging"}],"pipeline":[]},"currentOwner":"Mcguff","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"acetohydroxamic-acid","brandName":"acetohydroxamic acid","genericName":"acetohydroxamic acid","approvalYear":"1983","relationship":"same-target"},{"drugId":"atenolol","brandName":"atenolol","genericName":"atenolol","approvalYear":"1981","relationship":"same-target"},{"drugId":"dicoumarol","brandName":"dicoumarol","genericName":"dicoumarol","approvalYear":"1944","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT05855824","phase":"NA","title":"Toddler Biomarker of Nutrition Study","status":"NOT_YET_RECRUITING","sponsor":"Baylor College of Medicine","startDate":"2026-06-01","conditions":["Pediatric Nutrition","Nutrition, Healthy"],"enrollment":150,"completionDate":"2028-04-30"},{"nctId":"NCT03049462","phase":"PHASE1","title":"The Physiological Responses and 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Cullen, MD, FACS","startDate":"2018-11-16","conditions":["Carcinoma, Non-Small-Cell Lung","Non-Small Cell Lung Cancer","Nonsmall Cell Lung Cancer","Non-Small-Cell Lung Carcinoma","NSCLC"],"enrollment":43,"completionDate":"2027-12-31"},{"nctId":"NCT07184866","phase":"NA","title":"Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"Institute of Liver and Biliary Sciences, India","startDate":"2026-04","conditions":["Acute-on-Chronic Liver Failure (ACLF)"],"enrollment":110,"completionDate":"2027-10"},{"nctId":"NCT06439875","phase":"NA","title":"Effects of L-arginine and Liposomial Vitamin C on Severe Copd Patients Undergoing Pulmonary Rehabilitation.","status":"COMPLETED","sponsor":"Istituti Clinici Scientifici Maugeri SpA","startDate":"2024-07-16","conditions":["Chronic Obstructive Pulmonary Disease","Respiratory 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