prevident 5000 enamel protect

Generic: sodium fluoride and potassium nitrate

Labeler: colgate oral pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name prevident 5000 enamel protect
Generic Name sodium fluoride and potassium nitrate
Labeler colgate oral pharmaceuticals, inc.
Dosage Form GEL, DENTIFRICE
Routes
DENTAL
Active Ingredients

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

Manufacturer
Colgate Oral Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0126-0022
Product ID 0126-0022_6b3ab11f-e5c3-460b-8519-1214876dd629
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2011-03-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01260022
Hyphenated Format 0126-0022

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 prevident 5000 enamel protect (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 BOTTLE (0126-0022-92)
source: ndc

Packages (1)

0126-0022-92 100 mL in 1 BOTTLE (0126-0022-92)

Ingredients (2)

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

Linked Drug Pages (1)

PreviDent 5000 Enamel Protect ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "6b3ab11f-e5c3-460b-8519-1214876dd629", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "spl_set_id": ["bbc66b1b-e05c-4e14-bef3-b8bae419fc89"], "manufacturer_name": ["Colgate Oral Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (0126-0022-92)", "package_ndc": "0126-0022-92", "marketing_start_date": "20110330"}], "brand_name": "PreviDent 5000 Enamel Protect", "product_id": "0126-0022_6b3ab11f-e5c3-460b-8519-1214876dd629", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "0126-0022", "generic_name": "SODIUM FLUORIDE and POTASSIUM NITRATE", "labeler_name": "Colgate Oral Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PreviDent 5000 Enamel Protect", "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": "20110330", "listing_expiration_date": "20261231"}