enamur fluoride anticavity toothpast

Generic: fluoride toothpast

Labeler: protegera, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name enamur fluoride anticavity toothpast
Generic Name fluoride toothpast
Labeler protegera, inc
Dosage Form PASTE, DENTIFRICE
Routes
ORAL
Active Ingredients

sodium fluoride 1.4 mg/g

Manufacturer
Protegera, Inc

Identifiers & Regulatory

Product NDC 83610-1050
Product ID 83610-1050_39962a9d-e97a-d260-e063-6394a90a1b40
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2025-06-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 836101050
Hyphenated Format 83610-1050

Supplemental Identifiers

RxCUI
416783
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 enamur fluoride anticavity toothpast (source: ndc)
Generic Name fluoride toothpast (source: ndc)
Application Number M021 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.4 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (83610-1050-1) / 147 g in 1 TUBE
source: ndc

Packages (1)

Ingredients (1)

sodium fluoride (1.4 mg/g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "39962a9d-e97a-d260-e063-6394a90a1b40", "openfda": {"unii": ["8ZYQ1474W7"], "rxcui": ["416783"], "spl_set_id": ["557ced45-f54e-43d8-aa13-46f75b79367c"], "manufacturer_name": ["Protegera, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (83610-1050-1)  / 147 g in 1 TUBE", "package_ndc": "83610-1050-1", "marketing_start_date": "20250630"}], "brand_name": "Enamur Fluoride AntiCavity Toothpast", "product_id": "83610-1050_39962a9d-e97a-d260-e063-6394a90a1b40", "dosage_form": "PASTE, DENTIFRICE", "product_ndc": "83610-1050", "generic_name": "Fluoride Toothpast", "labeler_name": "Protegera, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Enamur Fluoride AntiCavity Toothpast", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": "1.4 mg/g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250630", "listing_expiration_date": "20261231"}