sodium fluoride 1.1%

Generic: sodium fluoride

Labeler: burel pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name sodium fluoride 1.1%
Generic Name sodium fluoride
Labeler burel pharmaceuticals llc
Dosage Form GEL, DENTIFRICE
Routes
DENTAL
Active Ingredients

sodium fluoride 5 mg/g

Manufacturer
Burel Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 35573-435
Product ID 35573-435_43929099-b98f-86b0-e063-6394a90a83e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2020-02-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35573435
Hyphenated Format 35573-435

Supplemental Identifiers

RxCUI
1486566
UNII
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 sodium fluoride 1.1% (source: ndc)
Generic Name sodium fluoride (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (35573-435-56) / 56 g in 1 TUBE
source: ndc

Packages (1)

35573-435-56 1 TUBE in 1 CARTON (35573-435-56) / 56 g in 1 TUBE

Ingredients (1)

sodium fluoride (5 mg/g)

Linked Drug Pages (1)

Sodium Fluoride 1.1% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "43929099-b98f-86b0-e063-6394a90a83e5", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["1486566"], "spl_set_id": ["6e021467-08b3-40b3-9a39-2e9d9830085d"], "manufacturer_name": ["Burel Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (35573-435-56)  / 56 g in 1 TUBE", "package_ndc": "35573-435-56", "marketing_start_date": "20200228"}], "brand_name": "Sodium Fluoride 1.1%", "product_id": "35573-435_43929099-b98f-86b0-e063-6394a90a83e5", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "35573-435", "generic_name": "Sodium Fluoride", "labeler_name": "Burel Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Fluoride 1.1%", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": "5 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20200228", "listing_expiration_date": "20261231"}