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

sodium fluoride .05 g/100mL

Manufacturer
Rowpar Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 58578-1234
Product ID 58578-1234_42ecdcc7-82b3-49f6-bff8-0b38c247433e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2016-02-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 585781234
Hyphenated Format 58578-1234

Supplemental Identifiers

RxCUI
240698
UPC
0647692627018 0647692227010
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 fluoride rinse (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .05 g/100mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (58578-1234-1) / 473 mL in 1 BOTTLE
source: ndc

Packages (1)

58578-1234-1 1 BOTTLE in 1 BOX (58578-1234-1) / 473 mL in 1 BOTTLE

Ingredients (1)

sodium fluoride (.05 g/100mL)

Linked Drug Pages (1)

CloSYS Fluoride Rinse ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42ecdcc7-82b3-49f6-bff8-0b38c247433e", "openfda": {"upc": ["0647692627018", "0647692227010"], "unii": ["8ZYQ1474W7"], "rxcui": ["240698"], "spl_set_id": ["1a994f24-99ee-4b27-aab0-e816931a22c8"], "manufacturer_name": ["Rowpar Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (58578-1234-1)  / 473 mL in 1 BOTTLE", "package_ndc": "58578-1234-1", "marketing_end_date": "20260401", "marketing_start_date": "20160218"}], "brand_name": "CloSYS Fluoride Rinse", "product_id": "58578-1234_42ecdcc7-82b3-49f6-bff8-0b38c247433e", "dosage_form": "RINSE", "product_ndc": "58578-1234", "generic_name": "Sodium Fluoride", "labeler_name": "Rowpar Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CloSYS", "brand_name_suffix": "Fluoride Rinse", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".05 g/100mL"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160218", "listing_expiration_date": "20261231"}