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 46 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Brush Buddies Barbie ANTICAVITY FLUORIDE - Bubble Gum Flavor SODIUM FLUORIDE Ashtel Studios Inc. bbf6cfe7-c5e5-4e63-ac7d-4535a0ca3973 2024-07-31 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 32780fe9-82bf-42f8-8218-bed5bc579c72 2024-07-30 Warnings Exact identifier application number: M021 Brush Buddies Hot Wheels ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 7ba8cff2-92a4-4432-aaf3-50358d9483a2 2024-07-30 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. ed057c95-90cd-4edb-ac00-78db8f6a065b 2024-07-29 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. f01c5eaf-7e81-4b30-bb6f-50566a727364 2024-07-29 Warnings Exact identifier application number: M021 Sodium Monofluorophosphate WHITE TOOTHPASTE Dynarex Corporation 1be422b9-6320-ed5c-e063-6294a90a7e42 2024-07-03 Warnings Exact identifier application number: M021 Wpgcng Antiacvity Fluoride Mouthwash SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 5756206e-43cc-8cc7-e063-6394a90a2950 2024-07-03 Warnings Exact identifier application number: M021 dentalux Kids ANTI-CAVITY FLUORIDE Bubble Gum SODIUM FLUORIDE Lidl US, LLC 0c77ba33-acb9-4c83-aa75-7d5c82f903eb 2024-07-02 Warnings Exact identifier application number: M021 dentalux ANTI-CAVITY FLUORIDE WHITENING MINT SODIUM FLUORIDE Lidl US, LLC 37011052-16ef-4ae4-aade-a86f9fa9cdac 2024-07-02 Warnings Exact identifier application number: M021 dentalux ANTI-CAVITY FLUORIDE SODIUM MONOFLUOROPHOSPHATE Lidl US, LLC ccf54743-81c2-43f8-9c5c-d4baa85fc18d 2024-07-02 Warnings Exact identifier application number: M021 SmileSense STANNOUS FLUORIDE SGII, INC 1c371393-da75-c9c8-e063-6294a90a5840 2024-07-01 Warnings Exact identifier application number: M021 Sodium Fluoride CLEAR MINT, GEL TOOTHPASTE Dynarex Corporation 1be193b6-4c07-4f0a-e063-6394a90a32c7 2024-06-27 Warnings Exact identifier application number: M021 CREST CAVITY PROTECTION COOL MINT SODIUM FLUORIDE A-S Medication Solutions dba7a572-a2f0-4c95-b2a7-cf7301e8ca9d 2024-06-12 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. a37e9d9c-dca9-4d58-a716-4514ebe8ec88 2024-06-11 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 0e6b01a4-1132-489f-936c-d3a54e9e21e0 2024-06-11 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. ffb8c43c-8f45-42ec-83eb-f0c83f7f99f8 2024-06-11 Warnings Exact identifier application number: M021 HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 1a26ad70-9773-dc4f-e063-6294a90ac333 2024-05-31 Warnings Exact identifier application number: M021 HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste SODIUM FLUORIDE LG H&H Co.,Ltd. 1a01481f-3e02-634e-e063-6394a90ac5fc 2024-05-31 Warnings Exact identifier application number: M021 Brush Buddies - Hot Wheels ANTICAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios Inc. 86dd5e9c-71c3-46ce-ae4c-45d19468667d 2024-05-29 Warnings Exact identifier application number: M021 Dentalclean Doctor Duck Kids Flouride Mouthwash SODIUM FLUORIDE 0.02% Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda 18806738-82fa-1a37-e063-6294a90a3888 2024-05-15 Warnings Exact identifier application number: M021
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