{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-06-02",
"results": {
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"results": [
{
"spl_product_data_elements": [
"Visine Allergy Eye Relief Multi-Action Naphazoline Hydrochloride and Pheniramine Maleate BENZALKONIUM CHLORIDE BORIC ACID EDETATE DISODIUM WATER SODIUM BORATE SODIUM HYDROXIDE HYDROCHLORIC ACID NAPHAZOLINE HYDROCHLORIDE NAPHAZOLINE PHENIRAMINE MALEATE PHENIRAMINE"
],
"spl_unclassified_section": [
"Drug Facts",
"Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558"
],
"active_ingredient": [
"Active ingredients Purpose Naphazoline HCl 0.025% Redness reliever Pheniramine maleate 0.3% Antihistamine"
],
"active_ingredient_table": [
"| Active ingredients | Purpose |
|---|
| Naphazoline HCl 0.025% | Redness reliever |
| Pheniramine maleate 0.3% | Antihistamine |
"
],
"purpose": [
"Active ingredients Purpose Naphazoline HCl 0.025% Redness reliever Pheniramine maleate 0.3% Antihistamine"
],
"purpose_table": [
"| Active ingredients | Purpose |
|---|
| Naphazoline HCl 0.025% | Redness reliever |
| Pheniramine maleate 0.3% | Antihistamine |
"
],
"indications_and_usage": [
"Uses Temporarily relieves itchy, red eyes due to: pollen ragweed grass animal hair and dander"
],
"warnings": [
"Warnings For external use only Do not use if you are sensitive to any ingredient in this product. Ask a doctor before use if you have heart disease high blood pressure narrow angle glaucoma trouble urinating When using this product pupils may become enlarged temporarily causing light sensitivity do not touch tip of container to any surface to avoid contamination replace cap after each use remove contact lenses before using do not use if this solution changes color or becomes cloudy overuse may cause more eye redness some users may experience a brief tingling sensation Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye lasts condition worsens or lasts more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature."
],
"do_not_use": [
"Do not use if you are sensitive to any ingredient in this product."
],
"ask_doctor": [
"Ask a doctor before use if you have heart disease high blood pressure narrow angle glaucoma trouble urinating"
],
"when_using": [
"When using this product pupils may become enlarged temporarily causing light sensitivity do not touch tip of container to any surface to avoid contamination replace cap after each use remove contact lenses before using do not use if this solution changes color or becomes cloudy overuse may cause more eye redness some users may experience a brief tingling sensation"
],
"stop_use": [
"Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye lasts condition worsens or lasts more than 72 hours"
],
"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. Accidental swallowing by infants and children may lead to coma and marked reduction in body temperature."
],
"dosage_and_administration": [
"Directions adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day children under 6 years of age: consult a doctor"
],
"storage_and_handling": [
"Other information Store at 15° to 25°C (59° to 77°F)"
],
"inactive_ingredient": [
"Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium hydroxide and/or hydrochloric acid"
],
"questions": [
"Questions? call toll-free 888-734-7648 or 215-273-8755 (collect)"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton VISINE ® NAPHAZOLINE HCl 0.025% AND PHENIRAMINE MALEATE 0.3% OPHTHALMIC SOLUTION ANTIHISTAMINE AND REDNESS RELIEVER ALLERGY EYE RELIEF MULTI-ACTION ORIGINAL PRESCRIPTION STRENGTH Clinically Proven to Relieve Red, Itchy Eyes STERILE EYE DROPS 1/2 FL OZ (15mL) 0367"
],
"set_id": "125fbc97-5bc8-436e-9ee9-e5a44384e260",
"id": "21eaa17e-eb96-aa1d-e063-6394a90a9870",
"effective_time": "20241113",
"version": "8",
"openfda": {
"application_number": [
"NDA020485"
],
"brand_name": [
"Visine Allergy Eye Relief Multi-Action"
],
"generic_name": [
"NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE"
],
"manufacturer_name": [
"Kenvue Brands LLC"
],
"product_ndc": [
"69968-0367"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"OPHTHALMIC"
],
"substance_name": [
"NAPHAZOLINE HYDROCHLORIDE",
"PHENIRAMINE MALEATE"
],
"rxcui": [
"1043658"
],
"spl_id": [
"21eaa17e-eb96-aa1d-e063-6394a90a9870"
],
"spl_set_id": [
"125fbc97-5bc8-436e-9ee9-e5a44384e260"
],
"package_ndc": [
"69968-0367-1",
"69968-0367-2"
],
"is_original_packager": [
true
],
"unii": [
"MZ1131787D",
"NYW905655B"
]
}
}
]
}