{"id":"zinc-sulfate","rwe":[],"_fda":{"id":"47491040-0b87-ee67-e063-6294a90a47d4","set_id":"07e1a56b-fdad-408d-bf5a-7a0144ece131","openfda":{"unii":["0YZT43HS7D","89DS0H96TB"],"route":["OPHTHALMIC"],"rxcui":["1043249"],"spl_id":["47491040-0b87-ee67-e063-6294a90a47d4"],"brand_name":["CVS Astringent Eye"],"spl_set_id":["07e1a56b-fdad-408d-bf5a-7a0144ece131"],"package_ndc":["69842-611-01"],"product_ndc":["69842-611"],"generic_name":["TETRAHYDROZOLINE HCL, ZINC SULFATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["TETRAHYDROZOLINE HYDROCHLORIDE","ZINC SULFATE"],"manufacturer_name":["CVS Pharmacy, Inc."],"application_number":["M018"],"is_original_packager":[true]},"purpose":["​Purpose Tetrahydrozoline HCl...Redness Reliever Zinc sulfate...Astringent"],"version":"5","stop_use":["Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours"],"warnings":["Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma When using this product pupils may become enlarged temporarily to avoid contamination, do not touch tip of container to any surface. Replace cap after using. if solution changes color or becomes cloudy, do not use overuse may produce increased redness of the eye remove contact lens before using Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away."],"pregnancy":["If pregnant or breast-feeding , ask a health professional before use."],"ask_doctor":["Ask a doctor before use if you have narrow angle glaucoma"],"when_using":["When using this product pupils may become enlarged temporarily to avoid contamination, do not touch tip of container to any surface. Replace cap after using. if solution changes color or becomes cloudy, do not use overuse may produce increased redness of the eye remove contact lens before using"],"effective_time":"20251230","active_ingredient":["​Active ingredients Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%"],"inactive_ingredient":["Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium citrate"],"indications_and_usage":["Uses for temporary relief of discomfort and redness of the eye due to minor eye irritations"],"other_safety_information":["Other information Store at 15°-30°C (59°-86°F)"],"dosage_and_administration":["Directions Instill 1 or 2 drops in the affected eye(s) up to four times daily."],"spl_product_data_elements":["CVS Astringent Eye Tetrahydrozoline HCl, Zinc sulfate BORIC ACID EDETATE DISODIUM WATER SODIUM CHLORIDE SODIUM CITRATE TETRAHYDROZOLINE HYDROCHLORIDE TETRAHYDROZOLINE ZINC SULFATE ZINC CATION BENZALKONIUM CHLORIDE"],"keep_out_of_reach_of_children":["Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["Carton"]},"tags":[{"label":"zinc sulfate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A12CB01","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Red eye","category":"indication"},{"label":"Zinc deficiency","category":"indication"},{"label":"Am Regent","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Astringents","category":"pharmacology"},{"label":"Dermatologic Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"219 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"173 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"167 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"156 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"150 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"148 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"139 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"137 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"128 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"100 reports"}],"commonSideEffects":[],"contraindications":["Angina pectoris","Angle-closure glaucoma","Dehydration","Depressive disorder","Diabetes mellitus","Diarrhea","Disease of liver","Disorder of cardiovascular system","Eye infection","Heart disease","Hypercalcemia","Hypercalciuria","Hyperglycemia","Hyperparathyroidism","Hypertensive disorder","Hyperthyroidism","Hypocupremia","Injury of eye region","Kidney disease","Kidney stone","Low blood pressure","Psychiatric Disturbance","Sarcoidosis"],"specialPopulations":{"Pregnancy":"Pregnancy Category C: Animal reproduction studies have not been conducted with MULTITRACE (R) 4 NEONATAL. It is also not known whether Neonatal Formula can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Neonatal Formula should be given to pregnant woman only if clearly needed."}},"trials":[],"aliases":[],"company":"Am Regent","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ZINC SULFATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:43:07.152515+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Zinc Sulfate","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:43:22.182115+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:43:20.192811+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:43:05.782929+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ZINC SULFATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:43:21.149551+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:43:04.774821+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:43:04.774881+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":"2026-04-20T00:43:23.139788+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200929/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:43:22.058479+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M018","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:43:04.774892+00:00"}},"allNames":["zinc sulfate heptahydrate","zinc sulfate","zincate","sulfuric acid zinc salt"],"offLabel":[],"synonyms":["zinc sulfate heptahydrate","zinc sulfate","zincate","sulfuric acid zinc salt"],"timeline":[{"date":"1987-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from ABRAXIS PHARM to Am Regent"},{"date":"1987-05-05","type":"positive","source":"DrugCentral","milestone":"FDA approval (Abraxis Pharm)"},{"date":"2023-08-22","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 3 manufacturers approved"}],"aiSummary":"Zinc Sulfate is a small molecule drug originally developed by ABRAXIS PHARM and currently owned by Am Regent. It was FDA approved in 1987 for the treatment of red eye and zinc deficiency. Zinc Sulfate is classified as a zinc sulfate drug and is available as a generic medication, with 8 generic manufacturers. The commercial status of Zinc Sulfate is off-patent, with no active Orange Book patents. As a zinc supplement, it plays a crucial role in various bodily functions, including immune system support and wound healing.","approvals":[{"date":"1987-05-05","orphan":false,"company":"ABRAXIS PHARM","regulator":"FDA"}],"brandName":"Zinc Sulfate","ecosystem":[{"indication":"Red eye","otherDrugs":[{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"crospovidone","slug":"crospovidone","company":""},{"name":"macrogol","slug":"macrogol","company":"Braintree"},{"name":"naphazoline","slug":"naphazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Zinc deficiency","otherDrugs":[{"name":"zinc chloride","slug":"zinc-chloride","company":"Hospira"},{"name":"zinc gluconate","slug":"zinc-gluconate","company":""}],"globalPrevalence":null}],"mechanism":{"novelty":"First-in-class","modality":"Small Molecule","drugClass":"zinc sulfate","explanation":"","oneSentence":"","technicalDetail":"Zinc Sulfate acts as a zinc ionophore, facilitating the transport of zinc ions across cell membranes and into cells, where it can participate in enzymatic reactions and other cellular processes."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Zinc_sulfate","title":"Zinc sulfate","extract":"Zinc sulfate is an inorganic compound with the formula ZnSO4. It forms hydrates ZnSO4·nH2O, where n can range from 0 to 7. All are colorless solids. The most common form includes water of crystallization as the heptahydrate, with the formula ZnSO4·7H2O. As early as the 16th century it was prepared on a large scale, and was historically known as \"white vitriol\" (the name was used, for example, in 1620s by the collective writing under the pseudonym of Basil Valentine). Zinc sulfate and its hydrates are colourless solids."},"commercial":{"launchDate":"1987","_launchSource":"DrugCentral (FDA 1987-05-05, ABRAXIS PHARM)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4275","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ZINC%20SULFATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ZINC SULFATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Zinc_sulfate","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":"2026-03-30T16:11:58.795313","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:43:24.996820+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"zinc gluconate","drugSlug":"zinc-gluconate","fdaApproval":"","relationship":"same-class"}],"genericName":"zinc sulfate","indications":{"approved":[{"name":"Red eye","source":"DrugCentral","snomedId":75705005,"regulator":"FDA","eligibility":"No eligibility criteria available"},{"name":"Zinc deficiency","source":"DrugCentral","snomedId":238124008,"regulator":"FDA","eligibility":"Neonates requiring TPN (Total Parenteral Nutrition) supplementation"}],"offLabel":[{"name":"Attention deficit hyperactivity disorder","source":"DrugCentral","drugName":"ZINC SULFATE","evidenceCount":7,"evidenceLevel":"emerging"},{"name":"Hereditary acrodermatitis enteropathica","source":"DrugCentral","drugName":"ZINC SULFATE"},{"name":"Impotence","source":"DrugCentral","drugName":"ZINC SULFATE","evidenceCount":6,"evidenceLevel":"emerging"},{"name":"Viral gastroenteritis","source":"DrugCentral","drugName":"ZINC SULFATE"}],"pipeline":[]},"currentOwner":"Am Regent","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"zinc-gluconate","brandName":"zinc gluconate","genericName":"zinc gluconate","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06517862","phase":"PHASE4","title":"Efficacy & Safety of Oral Adjuvants to Phototherapy in Neonatal Hyperbilirubinemia","status":"RECRUITING","sponsor":"Amira Adel Fouly","startDate":"2024-09-01","conditions":["Neonatal Hyperbilirubinemia"],"enrollment":80,"completionDate":"2026-06-30"},{"nctId":"NCT07398885","phase":"NA","title":"Assessing the Impact of Herbal Supplement on Fatigue and Disease Activity in SLE: Results From an 8-Week Randomized Trial","status":"COMPLETED","sponsor":"University Tunis El Manar","startDate":"2024-07-01","conditions":["System; Lupus Erythematosus"],"enrollment":59,"completionDate":"2025-05-07"},{"nctId":"NCT07383363","phase":"NA","title":"Comparison of Efficacy and Safety of Vita 6 Versus Zinc Along With Applied Behavioural Therapy","status":"RECRUITING","sponsor":"Muhammad Aamir Latif","startDate":"2025-09-23","conditions":["Autism Spectrum Disorder"],"enrollment":64,"completionDate":"2026-03-22"},{"nctId":"NCT07367412","phase":"NA","title":"Zinc Supplementation and Infections in Older Medical Patients","status":"NOT_YET_RECRUITING","sponsor":"Herlev Hospital","startDate":"2026-02-01","conditions":["Older Adults (65 Years and Older)","Medical Patients in the Emergency Department"],"enrollment":8000,"completionDate":"2028-03-15"},{"nctId":"NCT06561061","phase":"PHASE2,PHASE3","title":"Zinc for Infection Prevention in Sickle Cell Anemia-2 (ZIPS-2)","status":"COMPLETED","sponsor":"Indiana University","startDate":"2025-02-10","conditions":["Sickle Cell Disease"],"enrollment":100,"completionDate":"2025-11-07"},{"nctId":"NCT07366229","phase":"PHASE2","title":"Topical Application of Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne","status":"NOT_YET_RECRUITING","sponsor":"Shenzhen People's Hospital","startDate":"2025-12-30","conditions":["Acne"],"enrollment":196,"completionDate":"2026-06-30"},{"nctId":"NCT07275827","phase":"PHASE3","title":"Comparative Study Evaluating Safety and Effectiveness of ( Proton Pump Inhibitor Versus Vonoprazan ) Based Triple Therapy With or Without Zinc to Eradicate H. 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