dawnmist gel fluoride

Generic: gel fluoride toothpaste

Labeler: dukal llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dawnmist gel fluoride
Generic Name gel fluoride toothpaste
Labeler dukal llc
Dosage Form GEL, DENTIFRICE
Routes
DENTAL
Active Ingredients

sodium fluoride .22 g/100g

Manufacturer
Dukal LLC

Identifiers & Regulatory

Product NDC 65517-2004
Product ID 65517-2004_2d8d4082-db75-4bfc-e063-6294a90a540d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M021
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 655172004
Hyphenated Format 65517-2004

Supplemental Identifiers

RxCUI
245598
UPC
0665973010830 0665973010847 0665973010854
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 dawnmist gel fluoride (source: ndc)
Generic Name gel fluoride toothpaste (source: ndc)
Application Number M021 (source: ndc)
Routes
DENTAL
source: ndc

Resolved Composition

Strengths
  • .22 g/100g
source: ndc
Packaging
  • 78 g in 1 TUBE (65517-2004-0)
  • 17 g in 1 TUBE (65517-2004-1)
  • 24 g in 1 TUBE (65517-2004-2)
  • 43 g in 1 TUBE (65517-2004-3)
source: ndc

Packages (4)

65517-2004-0 78 g in 1 TUBE (65517-2004-0) 65517-2004-1 17 g in 1 TUBE (65517-2004-1) 65517-2004-2 24 g in 1 TUBE (65517-2004-2) 65517-2004-3 43 g in 1 TUBE (65517-2004-3)

Ingredients (1)

sodium fluoride (.22 g/100g)

Linked Drug Pages (1)

DawnMist Gel Fluoride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["DENTAL"], "spl_id": "2d8d4082-db75-4bfc-e063-6294a90a540d", "openfda": {"upc": ["0665973010830", "0665973010847", "0665973010854"], "unii": ["8ZYQ1474W7"], "rxcui": ["245598"], "spl_set_id": ["14443184-1694-70b9-e063-6394a90a86fe"], "manufacturer_name": ["Dukal LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "78 g in 1 TUBE (65517-2004-0)", "package_ndc": "65517-2004-0", "marketing_start_date": "20240501"}, {"sample": false, "description": "17 g in 1 TUBE (65517-2004-1)", "package_ndc": "65517-2004-1", "marketing_start_date": "20240501"}, {"sample": false, "description": "24 g in 1 TUBE (65517-2004-2)", "package_ndc": "65517-2004-2", "marketing_start_date": "20240501"}, {"sample": false, "description": "43 g in 1 TUBE (65517-2004-3)", "package_ndc": "65517-2004-3", "marketing_start_date": "20240501"}], "brand_name": "DawnMist Gel Fluoride", "product_id": "65517-2004_2d8d4082-db75-4bfc-e063-6294a90a540d", "dosage_form": "GEL, DENTIFRICE", "product_ndc": "65517-2004", "generic_name": "Gel Fluoride Toothpaste", "labeler_name": "Dukal LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DawnMist Gel Fluoride", "active_ingredients": [{"name": "SODIUM FLUORIDE", "strength": ".22 g/100g"}], "application_number": "M021", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}