Home NDC 65517-2004 DawnMist Gel Fluoride
Product NDC 65517-2004
11-digit product format 655172004
Labeler code 65517
Product ID 65517-2004_2d8d4082-db75-4bfc-e063-6294a90a540d
Type HUMAN OTC DRUG
Nonproprietary name Gel Fluoride Toothpaste
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Dukal LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-01
Substance SODIUM FLUORIDE
Active strength .22 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base DawnMist Gel Fluoride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .22 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 245598 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65517-2004-0 DawnMist Gel Fluoride 78 g in 1 TUBE GEL, DENTIFRICE 78 3 65517-2004-1 DawnMist Gel Fluoride 17 g in 1 TUBE GEL, DENTIFRICE 17 3 65517-2004-2 DawnMist Gel Fluoride 24 g in 1 TUBE GEL, DENTIFRICE 24 3 65517-2004-3 DawnMist Gel Fluoride 43 g in 1 TUBE GEL, DENTIFRICE 43 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65517-2004 DAWNMIST GEL FLUORIDE (GEL FLUORIDE TOOTHPASTE) GEL, DENTIFRICE [DUKAL LLC] 3 Current NDC, 4 package rows 20250210_14443184-1694-70b9-e063-6394a90a86fe.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 6 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65517-2004-0 65517200400 78 g in 1 TUBE (65517-2004-0) 78 g 2024-05-01 No No Current 65517-2004-1 65517200401 17 g in 1 TUBE (65517-2004-1) 17 g 2024-05-01 No No Current 65517-2004-2 65517200402 24 g in 1 TUBE (65517-2004-2) 24 g 2024-05-01 No No Current 65517-2004-3 65517200403 43 g in 1 TUBE (65517-2004-3) 43 g 2024-05-01 No No Current