{"id":"zinc-gluconate","rwe":[],"_fda":{"id":"4537e64e-662a-732e-e063-6294a90a0823","set_id":"016937dd-6599-849a-e063-6294a90a24d3","openfda":{"unii":["U6WSN5SQ1Z"],"route":["ORAL"],"spl_id":["4537e64e-662a-732e-e063-6294a90a0823"],"brand_name":["Cold-EEZE Cold Remedy"],"spl_set_id":["016937dd-6599-849a-e063-6294a90a24d3"],"package_ndc":["71179-320-25","71179-320-97"],"product_ndc":["71179-320"],"generic_name":["ZINC GLUCONATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["ZINC GLUCONATE"],"manufacturer_name":["Vespyr Brands Inc"],"is_original_packager":[true]},"purpose":["Purposes Cold remedy"],"version":"3","stop_use":["Stop use and ask your doctor if symptoms persist more than 7 days"],"warnings":["Warnings Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms. Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines. When using this product do not take on an empty stomach (to avoid possible minor stomach upset) Stop use and ask your doctor if symptoms persist more than 7 days If pregnant or breastfeeding , ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"questions":["Questions? call 1-800-505-2653 (Mon – Fri: 8AM – 5PM EST)"],"do_not_use":["Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms."],"when_using":["When using this product do not take on an empty stomach (to avoid possible minor stomach upset)"],"effective_time":"20251202","active_ingredient":["Active ingredient Active ingredient (per lozenge ) Zinc Gluconate 2X HPUS† (2.3%) (13.3 mg zinc) † The letters ‘HPUS’ indicate that the active ingredient is in the official Homeopathic Pharmacopeia of the United States."],"inactive_ingredient":["Inactive ingredients corn syrup, glycine, natural flavors, sucrose"],"storage_and_handling":["Other information store in a cool, dry place after opening best if used within 6 months after opening"],"indications_and_usage":["Uses reduces the duration of the common cold reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines."],"spl_unclassified_section":["Drug Facts"],"dosage_and_administration":["Directions • take one lozenge at the onset of symptoms • dissolve entire lozenge in mouth • do not chew • do not swallow whole • do not eat or drink for 15 minutes after use • repeat every 2-4 hours until symptoms subside Adults 18 years and over do not exceed 6 lozenges per day Children 12 to under 18 years do not exceed 4 lozenges per day Children under 12 years ask a doctor before use"],"spl_product_data_elements":["Cold-EEZE Cold Remedy Zinc Gluconate GLYCINE SUCROSE CORN SYRUP ZINC GLUCONATE ZINC CATION P"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding , ask a healthcare professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>Adults 18 years and over</td><td>do not exceed 6 lozenges per day</td></tr><tr><td>Children 12 to under 18 years</td><td>do not exceed 4 lozenges per day</td></tr><tr><td>Children under 12 years</td><td>ask a doctor before use</td></tr></tbody></table>"],"package_label_principal_display_panel":["25 ct package Cold-EEZE® COLD REMEDY ZINC GLUCONATE HOMEOPATHIC SHORTENS YOUR COLD® BY 42%* ORIGINAL CLINICALLY TESTED to Shorten Colds* PHARMACIST Recommended NATURAL CHERRY FLAVOR 25 Zinc Lozenges ©2024 Vespyr Brands®, LLC Cold-EEZE® is a registred trademark of Vespyr Brands®, LLC Distributed by Vespyr Brands®, LLC East Windsor, NJ 08520 This product has not been evaluated by the FDA *A clinical study found the Cold-EEZE formula reduces the duration of the common cold by 42%, when taken at the first sign of symptoms and used as directed. The double blind placebo controlled study was conducted at the Cleveland Clinic and published in a peer reviewed journal. 25 ct label","10 ct package Cold-EEZE® COLD REMEDY ZINC GLUCONATE HOMEOPATHIC SHORTENS YOUR COLD® BY 42%* ORIGINAL CLINICALLY TESTED to Shorten Colds* PHARMACIST Recommended NATURAL CHERRY FLAVOR 10 Lozenges ©2025 Vespyr Brands®, Inc. Cold-EEZE® is a registred trademark of Vespyr Brands®, LLC Distributed by Vespyr Brands®, LLC East Windsor, NJ 08520 This product has not been evaluated by the FDA and is not intended to diagnose, treat, cure, or prevent any disease. *A clinical study found the Cold-EEZE formula reduces the duration of the common cold by 42%, when taken at the first sign of symptoms and used as directed. The double blind placebo controlled study was conducted at the Cleveland Clinic and published in a peer reviewed journal. 10 ct label"]},"tags":[{"label":"zinc gluconate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"A12CB02","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Oral","category":"route"},{"label":"Topical","category":"route"},{"label":"Capsule","category":"form"},{"label":"Injection","category":"form"},{"label":"Liquid","category":"form"},{"label":"Powder","category":"form"},{"label":"Active","category":"status"},{"label":"Ascorbic acid deficiency","category":"indication"},{"label":"Zinc deficiency","category":"indication"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"2635 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"1920 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"1884 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"1883 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"1806 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"1758 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1509 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"1429 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"1323 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"1302 reports"}],"commonSideEffects":[],"contraindications":["Acute exacerbation of asthma","Acute tuberculosis","Allergic rhinitis","Anemia due to enzyme deficiency","Blood coagulation disorder","Diarrhea","Hb SS disease","Hemochromatosis","Human immunodeficiency virus infection","Hypertensive disorder","Hypocupremia","Leukemia, disease","Multiple sclerosis","Primary hyperoxaluria","Rheumatoid arthritis","Systemic lupus erythematosus"]},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ZINC GLUCONATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:35:05.639012+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:35:13.386361+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ZINC GLUCONATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:35:14.175365+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:35:03.342437+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:35:03.342498+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":"2026-04-20T03:35:15.773947+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL3833377/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:35:14.703332+00:00"}},"allNames":["zinc gluconate trihydrate","zinc gluconate"],"offLabel":[],"synonyms":["zinc gluconate trihydrate","zinc gluconate"],"timeline":[],"aiSummary":"Zinc Gluconate is a small molecule with the chemical name BIS(D-GLUCONATO-O1,O2) ZINC, used in various clinical trials for conditions such as hormonal acne, herpes simplex labialis, malaria, zinc deficiency, carcinoma, and non-small-cell lung carcinoma. It is administered orally as part of a treatment regimen, often in combination with other substances like lactoferrin and vitamin E.","approvals":[{"date":"","orphan":false,"company":"","regulator":"FDA"}],"ecosystem":[{"indication":"Ascorbic acid deficiency","otherDrugs":[{"name":"ascorbic acid","slug":"ascorbic-acid","company":""},{"name":"calcium pantothenate","slug":"calcium-pantothenate","company":"Hospira"}],"globalPrevalence":null},{"indication":"Zinc deficiency","otherDrugs":[{"name":"zinc chloride","slug":"zinc-chloride","company":"Hospira"},{"name":"zinc sulfate","slug":"zinc-sulfate","company":"Abraxis Pharm"}],"globalPrevalence":null}],"mechanism":{"novelty":"First-in-class","modality":"Small Molecule","drugClass":"zinc gluconate","explanation":"","oneSentence":"","technicalDetail":"Zinc gluconate acts as a zinc ionophore, facilitating the transport of zinc ions across cell membranes and into the cytosol, where they can participate in various enzymatic reactions and signaling pathways."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4343","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ZINC%20GLUCONATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ZINC GLUCONATE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T16:16:05.599868","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:35:17.705621+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"zinc sulfate","drugSlug":"zinc-sulfate","fdaApproval":"1987-05-05","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"zinc gluconate","indications":{"approved":[{"name":"Ascorbic acid 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GLUCONATE","evidenceCount":0,"evidenceLevel":"emerging"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"zinc-sulfate","brandName":"zinc sulfate","genericName":"zinc sulfate","approvalYear":"1987","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07240246","phase":"NA","title":"Effect of a Dietary Supplement on Hormones Involved in Appetite Regulation in Overweight and Obese Adults","status":"ACTIVE_NOT_RECRUITING","sponsor":"FFoQSI - Austrian Competence Centre for Feed and Food Quality, Safety & Innovation","startDate":"2025-10-24","conditions":["GLP-1","Obesity &Amp; Overweight","Dietary Supplement"],"enrollment":40,"completionDate":"2026-05-11"},{"nctId":"NCT05853692","phase":"NA","title":"Prevention of Oral Mucositis in Head and Neck Cancer.","status":"RECRUITING","sponsor":"Catholic University of the Sacred Heart","startDate":"2022-10-10","conditions":["Oral 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