fluoridex

Generic: sodium fluoride

Labeler: dent-mat holdings, llc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name fluoridex
Generic Name sodium fluoride
Labeler dent-mat holdings, llc.
Dosage Form PASTE, DENTIFRICE
Routes
DENTAL
Active Ingredients

potassium nitrate 50 mg/g, sodium fluoride 5 mg/g

Manufacturer
DENT-MAT HOLDINGS, LLC.

Identifiers & Regulatory

Product NDC 59883-031
Product ID 59883-031_2cf0556f-5090-c02c-e063-6394a90a4b40
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2016-12-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59883031
Hyphenated Format 59883-031

Supplemental Identifiers

RxCUI
637365 847014
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 fluoridex (source: ndc)
Generic Name sodium fluoride (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
  • 5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (59883-031-04) / 112 g in 1 TUBE
  • 24 g in 1 TUBE (59883-031-05)
source: ndc

Packages (2)

59883-031-04 1 TUBE in 1 BOX (59883-031-04) / 112 g in 1 TUBE 59883-031-05 24 g in 1 TUBE (59883-031-05)

Ingredients (2)

potassium nitrate (50 mg/g) sodium fluoride (5 mg/g)

Linked Drug Pages (1)

FLUORIDEX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "2cf0556f-5090-c02c-e063-6394a90a4b40", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "rxcui": ["637365", "847014"], "spl_set_id": ["601774d5-f4de-01bc-e053-2991aa0a7f4f"], "manufacturer_name": ["DENT-MAT HOLDINGS, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (59883-031-04)  / 112 g in 1 TUBE", "package_ndc": "59883-031-04", "marketing_start_date": "20161221"}, {"sample": true, "description": "24 g in 1 TUBE (59883-031-05)", "package_ndc": "59883-031-05", "marketing_start_date": "20180822"}], "brand_name": "FLUORIDEX", "product_id": "59883-031_2cf0556f-5090-c02c-e063-6394a90a4b40", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "59883-031", "generic_name": "Sodium Fluoride", "labeler_name": "DENT-MAT HOLDINGS, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FLUORIDEX", "active_ingredients": [{"name": "POTASSIUM NITRATE", "strength": "50 mg/g"}, {"name": "SODIUM FLUORIDE", "strength": "5 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20161221", "listing_expiration_date": "20261231"}