closys

Generic: sodium fluoride

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

Drug Facts

Product Profile

Brand Name closys
Generic Name sodium fluoride
Labeler rowpar pharmaceuticals, inc.
Dosage Form PASTE, DENTIFRICE
Routes
ORAL
Active Ingredients

sodium fluoride .916 mg/g

Manufacturer
Rowpar Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 58578-0759
Product ID 58578-0759_f3050239-2f5f-47de-b91c-99c31cb28f2a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2020-01-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 585780759
Hyphenated Format 58578-0759

Supplemental Identifiers

RxCUI
1099038
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 (source: ndc)
Generic Name sodium fluoride (source: ndc)
Application Number M021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .916 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (58578-0759-1) / 96 g in 1 TUBE
  • 2 TUBE in 1 PACKAGE (58578-0759-3) / 96 g in 1 TUBE
source: ndc

Packages (2)

58578-0759-1 1 TUBE in 1 BOX (58578-0759-1) / 96 g in 1 TUBE 58578-0759-3 2 TUBE in 1 PACKAGE (58578-0759-3) / 96 g in 1 TUBE

Ingredients (1)

sodium fluoride (.916 mg/g)

Linked Drug Pages (1)

CloSYS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f3050239-2f5f-47de-b91c-99c31cb28f2a", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["1099038"], "spl_set_id": ["ed617c7a-805c-4788-9bce-9b7fead4312d"], "manufacturer_name": ["Rowpar Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (58578-0759-1)  / 96 g in 1 TUBE", "package_ndc": "58578-0759-1", "marketing_start_date": "20200106"}, {"sample": false, "description": "2 TUBE in 1 PACKAGE (58578-0759-3)  / 96 g in 1 TUBE", "package_ndc": "58578-0759-3", "marketing_start_date": "20200106"}], "brand_name": "CloSYS", "product_id": "58578-0759_f3050239-2f5f-47de-b91c-99c31cb28f2a", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "58578-0759", "generic_name": "Sodium fluoride", "labeler_name": "Rowpar Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CloSYS", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".916 mg/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200106", "listing_expiration_date": "20261231"}