sodium fluoride and potassium nitrate

Generic: sodium fluoride and potassium nitrate

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name sodium fluoride and potassium nitrate
Generic Name sodium fluoride and potassium nitrate
Labeler westminster pharmaceuticals, llc
Dosage Form GEL
Routes
DENTAL
Active Ingredients

potassium nitrate 57.5 mg/mL, sodium fluoride 5.8 mg/mL

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-318
Product ID 69367-318_0c9c8462-f962-4615-8649-dea8e1ecb498
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2022-06-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367318
Hyphenated Format 69367-318

Supplemental Identifiers

RxCUI
637365
UNII
RU45X2JN0Z 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 sodium fluoride and potassium nitrate (source: ndc)
Generic Name sodium fluoride and potassium nitrate (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 57.5 mg/mL
  • 5.8 mg/mL
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (69367-318-01) / 100 mL in 1 TUBE
source: ndc

Packages (1)

69367-318-01 1 TUBE in 1 CARTON (69367-318-01) / 100 mL in 1 TUBE

Ingredients (2)

potassium nitrate (57.5 mg/mL) sodium fluoride (5.8 mg/mL)

Linked Drug Pages (1)

Sodium Fluoride and Potassium Nitrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "0c9c8462-f962-4615-8649-dea8e1ecb498", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "rxcui": ["637365"], "spl_set_id": ["7a051d80-879d-4995-96ef-77b60dad26b7"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (69367-318-01)  / 100 mL in 1 TUBE", "package_ndc": "69367-318-01", "marketing_start_date": "20220615"}], "brand_name": "Sodium Fluoride and Potassium Nitrate", "product_id": "69367-318_0c9c8462-f962-4615-8649-dea8e1ecb498", "dosage_form": "GEL", "product_ndc": "69367-318", "generic_name": "Sodium Fluoride and Potassium Nitrate", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Fluoride and Potassium Nitrate", "active_ingredients": [{"name": "POTASSIUM NITRATE", "strength": "57.5 mg/mL"}, {"name": "SODIUM FLUORIDE", "strength": "5.8 mg/mL"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20220615", "listing_expiration_date": "20261231"}