{"id":"naphazoline","rwe":[],"_fda":{"id":"47492a43-35f4-5c2c-e063-6394a90a5b7f","set_id":"0042e9a0-9693-d7e0-e063-6294a90ae6c6","openfda":{"nui":["N0000185370","N0000175629","N0000184306","N0000185001","M0000728","M0009417"],"upc":["0010939958310"],"unii":["PDC6A3C0OX","MZ1131787D"],"route":["OPHTHALMIC"],"rxcui":["1046700"],"spl_id":["47492a43-35f4-5c2c-e063-6394a90a5b7f"],"brand_name":["Foster and Thrive Redness Relief Eye Drops"],"spl_set_id":["0042e9a0-9693-d7e0-e063-6294a90ae6c6"],"package_ndc":["70677-1161-1"],"product_ndc":["70677-1161"],"generic_name":["GLYCERIN, NAPHAZOLINE HCL"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Allergens [CS]","Glycerol [CS]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Increased IgG Production [PE]"],"substance_name":["GLYCERIN","NAPHAZOLINE HYDROCHLORIDE"],"pharm_class_epc":["Non-Standardized Chemical Allergen [EPC]"],"manufacturer_name":["Strategic Sourcing Services LLC"],"application_number":["M018"],"is_original_packager":[true]},"purpose":["Purposes Lubricant Redness reliever"],"version":"3","stop_use":["Stop use and ask a doctor if you experience eye pain you experience changes in vision you experience continued redness or irritation of the eye the condition worsens or persists for more than 72 hours"],"warnings":["Warnings For external use only Do not use if solution changes color or becomes cloudy Ask a doctor before use if you have narrow angle glaucoma When using this product to avoid contamination, do not touch tip of container to any surface replace cap after using overuse may produce increased redness of the eye pupils may become enlarged temporarily Stop use and ask a doctor if you experience eye pain you experience changes in vision you experience continued redness or irritation of the eye the condition worsens or persists for more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"questions":["Questions or comments? Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST"],"ask_doctor":["Ask a doctor before use if you have narrow angle glaucoma"],"do_not_use":["Do not use if solution changes color or becomes cloudy"],"when_using":["When using this product to avoid contamination, do not touch tip of container to any surface replace cap after using overuse may produce increased redness of the eye pupils may become enlarged temporarily"],"effective_time":"20251230","active_ingredient":["Active ingredients Glycerin 0.25% Naphazoline HCl 0.012%"],"inactive_ingredient":["Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate"],"indications_and_usage":["Uses relieves redness of the eye due to minor eye irritations for use as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of burning and irritation due to dryness of the eye"],"other_safety_information":["Other information store at room temperature"],"dosage_and_administration":["Directions instill 1 to 2 drops in the affected eye(s) up to 4 times daily"],"spl_product_data_elements":["Foster and Thrive Redness Relief Eye Drops Glycerin, Naphazoline HCl WATER NAPHAZOLINE HYDROCHLORIDE NAPHAZOLINE SODIUM BORATE BENZALKONIUM CHLORIDE EDETATE DISODIUM BORIC ACID GLYCERIN GLYCERIN"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"package_label_principal_display_panel":["Foster & Thrive Redness Relief Eye Drops 15mL Foster and Thrive Redness Relief Eye Drops 15mL"]},"tags":[{"label":"naphazoline","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Alpha-2A adrenergic receptor","category":"target"},{"label":"ADRA2A","category":"gene"},{"label":"NISCH","category":"gene"},{"label":"ADRA2B","category":"gene"},{"label":"R01AA08","category":"atc"},{"label":"Ophthalmic","category":"route"},{"label":"Nasal","category":"route"},{"label":"Liquid","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Ocular Itching","category":"indication"},{"label":"Red eye","category":"indication"},{"label":"Novartis","category":"company"},{"label":"Approved 1970s","category":"decade"},{"label":"Adrenergic Agents","category":"pharmacology"},{"label":"Adrenergic Agonists","category":"pharmacology"},{"label":"Adrenergic alpha-Agonists","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Nasal Decongestants","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Respiratory System Agents","category":"pharmacology"},{"label":"Vasoconstrictor Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":36.728,"date":"","count":10,"signal":"Eye irritation","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=37)"}],"commonSideEffects":[],"contraindications":["Angle-closure glaucoma","Diabetes mellitus","Disorder of cardiovascular system","Eye infection","Hyperglycemia","Hypertensive disorder","Hyperthyroidism","Injury of eye region"],"specialPopulations":{"Pregnancy":"Pregnancy Category C: Animal reproduction studies have not been conducted with naphazoline. It is also not known whether naphazoline can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. Naphazoline should be given to pregnant woman only if clearly needed.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established. See WARNINGS. and CONTRAINDICATIONS.."}},"trials":[],"aliases":[],"company":"Novartis","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=NAPHAZOLINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T05:49:15.633250+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T05:49:21.169308+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=NAPHAZOLINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T05:49:21.400766+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":"2026-04-20T05:49:14.511478+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:49:14.511498+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:49:14.511502+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Adrenergic receptor alpha agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:49:22.447229+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1706/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:49:22.111562+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M018","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:49:14.511505+00:00"}},"allNames":"naphcon forte","offLabel":[],"synonyms":["naphazoline nitrate","naphazoline","naphthazoline","naphthizine","nephazoline","rhinazine","naphazoline hydrochloride","naphazoline HCl"],"timeline":[{"date":"1971-06-07","type":"positive","source":"DrugCentral","milestone":"FDA approval (Novartis)"}],"aiSummary":"Naphcon Forte (Naphazoline) is a small molecule drug developed by Novartis that targets the alpha-2A adrenergic receptor. It is classified as a naphazoline and was FDA approved in 1971 for the treatment of ocular itching and red eye. As an off-patent medication, Naphcon Forte is available from multiple generic manufacturers. Key safety considerations include potential rebound effects and interactions with other medications. Naphcon Forte is a commercially available medication with a long history of use.","approvals":[{"date":"1971-06-07","orphan":false,"company":"NOVARTIS","regulator":"FDA"}],"brandName":"Naphcon Forte","ecosystem":[{"indication":"Ocular Itching","otherDrugs":[{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"epinastine","slug":"epinastine","company":"Allergan"},{"name":"nedocromil","slug":"nedocromil","company":"King Pharms"},{"name":"pheniramine","slug":"pheniramine","company":"Alcon"}],"globalPrevalence":null},{"indication":"Red eye","otherDrugs":[{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"crospovidone","slug":"crospovidone","company":""},{"name":"macrogol","slug":"macrogol","company":"Braintree"},{"name":"oxymetazoline","slug":"oxymetazoline","company":"Bayer Healthcare Llc"}],"globalPrevalence":null}],"mechanism":{"target":"Alpha-2A adrenergic receptor","novelty":"Follow-on","targets":[{"gene":"ADRA2A","source":"DrugCentral","target":"Alpha-2A adrenergic receptor","protein":"Alpha-2A adrenergic receptor"},{"gene":"NISCH","source":"DrugCentral","target":"Nischarin","protein":"Nischarin"},{"gene":"ADRA2B","source":"DrugCentral","target":"Alpha-2B adrenergic receptor","protein":"Alpha-2B adrenergic receptor"},{"gene":"ADRA2C","source":"DrugCentral","target":"Alpha-2C adrenergic receptor","protein":"Alpha-2C adrenergic receptor"}],"modality":"Small Molecule","drugClass":"Non-Standardized Chemical Allergen [EPC]","explanation":"","oneSentence":"","technicalDetail":"Naphcon Forte acts as an agonist at the alpha-2A adrenergic receptor, leading to vasoconstriction and a decrease in aqueous humor production, which in turn reduces ocular itching and redness."},"commercial":{"launchDate":"1971","_launchSource":"DrugCentral (FDA 1971-06-07, NOVARTIS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/3369","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=NAPHAZOLINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=NAPHAZOLINE","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":"2026-03-30T12:54:13.089315","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T05:49:24.079303+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"ephedrine","drugSlug":"ephedrine","fdaApproval":"","patentExpiry":"May 16, 2040","patentStatus":"Patent 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