closys silver sensitive mouth rinse fluoride rinse

Generic: sodium fluoride

Labeler: rowpar pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name closys silver sensitive mouth rinse fluoride rinse
Generic Name sodium fluoride
Labeler rowpar pharmaceuticals, inc.
Dosage Form RINSE
Routes
ORAL
Active Ingredients

sodium fluoride .02 g/100mL

Manufacturer
Rowpar Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 58578-0517
Product ID 58578-0517_7789eb99-7c54-4604-8598-2238617b04d7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2023-01-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 585780517
Hyphenated Format 58578-0517

Supplemental Identifiers

RxCUI
313029
UNII
8ZYQ1474W7

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name closys silver sensitive mouth rinse fluoride rinse (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .02 g/100mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (58578-0517-1) / 473 mL in 1 BOTTLE
  • 2 BOTTLE in 1 PACKAGE (58578-0517-2) / 946 mL in 1 BOTTLE
  • 3 BOTTLE in 1 PACKAGE (58578-0517-3) / 946 mL in 1 BOTTLE
  • 946 mL in 1 BOTTLE (58578-0517-4)
source: ndc

Packages (4)

58578-0517-1 1 BOTTLE in 1 BOX (58578-0517-1) / 473 mL in 1 BOTTLE 58578-0517-2 2 BOTTLE in 1 PACKAGE (58578-0517-2) / 946 mL in 1 BOTTLE 58578-0517-3 3 BOTTLE in 1 PACKAGE (58578-0517-3) / 946 mL in 1 BOTTLE 58578-0517-4 946 mL in 1 BOTTLE (58578-0517-4)

Ingredients (1)

sodium fluoride (.02 g/100mL)

Linked Drug Pages (1)

CloSYS Silver Sensitive Mouth Rinse Fluoride Rinse ndc-match (0.9)

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"}