denta 5000 plus sensitive

Generic: sodium fluoride and potassium nitrate

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name denta 5000 plus sensitive
Generic Name sodium fluoride and potassium nitrate
Labeler rising pharma holdings, inc.
Dosage Form GEL, DENTIFRICE
Routes
DENTAL
Active Ingredients

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

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-823
Product ID 16571-823_3d38b4ec-9283-448f-8fc5-d51cca9de7a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2024-02-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571823
Hyphenated Format 16571-823

Supplemental Identifiers

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 denta 5000 plus sensitive (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
  • 100 mL in 1 TUBE (16571-823-10)
source: ndc

Packages (1)

16571-823-10 100 mL in 1 TUBE (16571-823-10)

Ingredients (2)

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

Linked Drug Pages (1)

Denta 5000 Plus Sensitive ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "3d38b4ec-9283-448f-8fc5-d51cca9de7a6", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "spl_set_id": ["585fb1f5-8c08-43bd-8be4-64adc065d9a2"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 TUBE (16571-823-10)", "package_ndc": "16571-823-10", "marketing_start_date": "20240214"}], "brand_name": "Denta 5000 Plus Sensitive", "product_id": "16571-823_3d38b4ec-9283-448f-8fc5-d51cca9de7a6", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "16571-823", "generic_name": "Sodium fluoride and Potassium nitrate", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Denta 5000 Plus Sensitive", "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": "20240214", "listing_expiration_date": "20261231"}