Package 58578-0517-4
Brand: closys silver sensitive mouth rinse fluoride rinse
Generic: sodium fluoridePackage Facts
Identity
Package NDC
58578-0517-4
Digits Only
5857805174
Product NDC
58578-0517
Description
946 mL in 1 BOTTLE (58578-0517-4)
Marketing
Marketing Status
Brand
closys silver sensitive mouth rinse fluoride rinse
Generic
sodium fluoride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "7789eb99-7c54-4604-8598-2238617b04d7", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["313029"], "spl_set_id": ["98a8cee8-9f3c-4a4a-89f8-72e1f1b06796"], "manufacturer_name": ["Rowpar Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (58578-0517-1) / 473 mL in 1 BOTTLE", "package_ndc": "58578-0517-1", "marketing_start_date": "20240101"}, {"sample": false, "description": "2 BOTTLE in 1 PACKAGE (58578-0517-2) / 946 mL in 1 BOTTLE", "package_ndc": "58578-0517-2", "marketing_start_date": "20240101"}, {"sample": false, "description": "3 BOTTLE in 1 PACKAGE (58578-0517-3) / 946 mL in 1 BOTTLE", "package_ndc": "58578-0517-3", "marketing_start_date": "20240101"}, {"sample": false, "description": "946 mL in 1 BOTTLE (58578-0517-4)", "package_ndc": "58578-0517-4", "marketing_start_date": "20240101"}], "brand_name": "CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse", "product_id": "58578-0517_7789eb99-7c54-4604-8598-2238617b04d7", "dosage_form": "RINSE", "product_ndc": "58578-0517", "generic_name": "Sodium Fluoride", "labeler_name": "Rowpar Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CloSYS Silver Sensitive Mouth Rinse", "brand_name_suffix": "Fluoride Rinse", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".02 g/100mL"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230101", "listing_expiration_date": "20261231"}