ionite h

Generic: sodium fluoride, potassium nitrate

Labeler: dharma research, inc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name ionite h
Generic Name sodium fluoride, potassium nitrate
Labeler dharma research, inc.
Dosage Form GEL, DENTIFRICE
Routes
DENTAL
Active Ingredients

potassium nitrate 5 mg/100g, sodium fluoride 1.1 mg/100g

Manufacturer
Dharma Research, Inc.

Identifiers & Regulatory

Product NDC 53045-280
Product ID 53045-280_0b21c890-82f5-4e90-8aa1-1e06d631760e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2015-08-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53045280
Hyphenated Format 53045-280

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 ionite h (source: ndc)
Generic Name sodium fluoride, potassium nitrate (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/100g
  • 1.1 mg/100g
source: ndc
Packaging
  • 122 g in 1 TUBE (53045-280-04)
source: ndc

Packages (1)

53045-280-04 122 g in 1 TUBE (53045-280-04)

Ingredients (2)

potassium nitrate (5 mg/100g) sodium fluoride (1.1 mg/100g)

Linked Drug Pages (1)

Ionite H ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "0b21c890-82f5-4e90-8aa1-1e06d631760e", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "rxcui": ["637365"], "spl_set_id": ["54c1a27c-5936-4ee2-a419-3891d3df9745"], "manufacturer_name": ["Dharma Research, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "122 g in 1 TUBE (53045-280-04)", "package_ndc": "53045-280-04", "marketing_start_date": "20150802"}], "brand_name": "Ionite H", "product_id": "53045-280_0b21c890-82f5-4e90-8aa1-1e06d631760e", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "53045-280", "generic_name": "Sodium Fluoride, Potassium Nitrate", "labeler_name": "Dharma Research, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ionite H", "active_ingredients": [{"name": "POTASSIUM NITRATE", "strength": "5 mg/100g"}, {"name": "SODIUM FLUORIDE", "strength": "1.1 mg/100g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20150802", "listing_expiration_date": "20261231"}