sensitive tooth polish

Generic: potassium nitrate and sodium fluoride

Labeler: melaleuca, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH NOT FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name sensitive tooth polish
Generic Name potassium nitrate and sodium fluoride
Labeler melaleuca, inc.
Dosage Form PASTE, DENTIFRICE
Routes
TOPICAL
Active Ingredients

potassium nitrate 5.4 g/108g, sodium fluoride .26244 g/108g

Manufacturer
Melaleuca, Inc.

Identifiers & Regulatory

Product NDC 54473-302
Product ID 54473-302_68933f55-0cd9-0074-e053-2991aa0adfb7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH NOT FINAL
Application Number part356
Listing Expiration 2026-12-31
Marketing Start 2012-01-03

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54473302
Hyphenated Format 54473-302

Supplemental Identifiers

RxCUI
1038800
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 sensitive tooth polish (source: ndc)
Generic Name potassium nitrate and sodium fluoride (source: ndc)
Application Number part356 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5.4 g/108g
  • .26244 g/108g
source: ndc
Packaging
  • 108 g in 1 TUBE (54473-302-04)
source: ndc

Packages (1)

54473-302-04 108 g in 1 TUBE (54473-302-04)

Ingredients (2)

potassium nitrate (5.4 g/108g) sodium fluoride (.26244 g/108g)

Linked Drug Pages (1)

Sensitive Tooth Polish ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "68933f55-0cd9-0074-e053-2991aa0adfb7", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "rxcui": ["1038800"], "spl_set_id": ["689349e4-3980-a0e4-e053-2991aa0a9ef5"], "manufacturer_name": ["Melaleuca, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "108 g in 1 TUBE (54473-302-04)", "package_ndc": "54473-302-04", "marketing_start_date": "20180101"}], "brand_name": "Sensitive Tooth Polish", "product_id": "54473-302_68933f55-0cd9-0074-e053-2991aa0adfb7", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "54473-302", "generic_name": "Potassium Nitrate and Sodium Fluoride", "labeler_name": "Melaleuca, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sensitive", "brand_name_suffix": "Tooth Polish", "active_ingredients": [{"name": "POTASSIUM NITRATE", "strength": "5.4 g/108g"}, {"name": "SODIUM FLUORIDE", "strength": ".26244 g/108g"}], "application_number": "part356", "marketing_category": "OTC MONOGRAPH NOT FINAL", "marketing_start_date": "20120103", "listing_expiration_date": "20261231"}