sodium fluoride 5000 ppm enamel protect

Generic: sodium fluoride1.1%, potassium nitrate 5%

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

Drug Facts

Product Profile

Brand Name sodium fluoride 5000 ppm enamel protect
Generic Name sodium fluoride1.1%, potassium nitrate 5%
Labeler sheffield pharmaceuticals llc
Dosage Form GEL, DENTIFRICE
Routes
DENTAL
Active Ingredients

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

Manufacturer
Sheffield Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 11527-745
Product ID 11527-745_3fa71e96-0c84-4ce6-8aa8-6689b876c480
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2021-01-08

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11527745
Hyphenated Format 11527-745

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 sodium fluoride 5000 ppm enamel protect (source: ndc)
Generic Name sodium fluoride1.1%, potassium nitrate 5% (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • 57.5 mg/mL
  • 5.8 mg/mL
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (11527-745-34) / 100 mL in 1 TUBE
source: ndc

Packages (1)

11527-745-34 1 TUBE in 1 CARTON (11527-745-34) / 100 mL in 1 TUBE

Ingredients (2)

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

Linked Drug Pages (1)

Sodium Fluoride 5000 ppm Enamel Protect ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "3fa71e96-0c84-4ce6-8aa8-6689b876c480", "openfda": {"unii": ["RU45X2JN0Z", "8ZYQ1474W7"], "spl_set_id": ["83dfdead-4f71-404e-90ae-dbd6849c7cf1"], "manufacturer_name": ["Sheffield Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (11527-745-34)  / 100 mL in 1 TUBE", "package_ndc": "11527-745-34", "marketing_start_date": "20210108"}], "brand_name": "Sodium Fluoride 5000 ppm Enamel Protect", "product_id": "11527-745_3fa71e96-0c84-4ce6-8aa8-6689b876c480", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "11527-745", "generic_name": "Sodium Fluoride1.1%, Potassium Nitrate 5%", "labeler_name": "Sheffield Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Fluoride 5000 ppm 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": "20210108", "listing_expiration_date": "20261231"}