Home NDC 65517-2004-01 NDC 65517-2004-01 - DawnMist Gel Fluoride This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
Product NDC 65517-2004
Requested NDC 65517-2004-01
Package NDCs from labels 65517-2004-1, 65517-2004-0, 65517-2004-2, 65517-2004-3, 65517-2004-01
Manufacturer Dukal LLC
Effective date 2025-02-07
Current FDA listing Not matched in FDA.report NDC product tables 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 17 of 111 · 2,214 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join A and H Plus Therabreath Breath Freshners SODIUM FLUORIDE Church & Dwight Co., Inc. 18d6073e-b1ee-47d2-9758-2cf04f3cf3ca 2026-04-23 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 3ECARE Dual formula WhiteningToothpaste Refill SODIUM FLUORIDE Hangzhou Namei Zhikang Technology Co., Ltd. 501df1c7-4884-bb39-e063-6294a90aaf6a 2026-04-23 Warnings Exact identifier unii: 8ZYQ1474W7 Fluoride SODIUM FLUORIDE McKesson 5025e58e-e59c-07b6-e063-6394a90ac1e8 2026-04-23 Warnings Exact identifier application number: M021 rxcui: 245598 unii: 8ZYQ1474W7 PRO-SYS SENSITIVITY - MINT (OTC) Benco Dental 4e46847e-8c1d-c988-e063-6394a90a8e50 2026-04-22 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 Anticavity Fluoride Rinse SODIUM FLUORIDE H E B 87327a36-a314-4daa-83b6-b4bd3e26bba2 2026-04-22 Warnings, Adverse reactions Exact identifier application number: M021 unii: 8ZYQ1474W7 Anticavity SODIUM FLUORIDE H E B 8df324a7-9204-40f3-8ddb-1656286d7d4e 2026-04-22 Warnings, Adverse reactions Exact identifier application number: M021 unii: 8ZYQ1474W7 Colgate Total SF Whitening STANNOUS FLUORIDE Colgate-Palmolive Company 3bba340e-2a62-3b04-41b5-0ed9c13adb13 2026-04-22 Warnings Exact identifier application number: M021 EverSmile AlignerFresh Enamel Guard SODIUM FLUORIDE Everbrands, Inc. 7b3d0114-dac0-4370-8545-922ec018018e 2026-04-21 Warnings Exact identifier unii: 8ZYQ1474W7 EverSmile Squirt SODIUM FLUORIDE 0.05% Everbrands, Inc. bc0ef174-2909-469a-b629-0eab4412bdfc 2026-04-20 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 Gum Detoxify STANNOUS FLUORIDE Walmart 41d6cc7a-0b87-e474-e063-6294a90ae995 2026-04-20 Warnings Exact identifier application number: M021 Eversmile Squirt 2.65% HYDROGEN PEROXIDE Everbrands, Inc. 2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf 2026-04-19 Warnings Exact identifier application number: M021 Alcohol-Free Anticavity SODIUM FLUORIDE H E B 8d40f693-083c-4eb6-9da1-42675d757e0e 2026-04-16 Warnings, Adverse reactions Exact identifier application number: M021 unii: 8ZYQ1474W7 Eversmile OrthoFoam Anticavity 0.05% SODIUM FLUORIDE RINSE Everbrands, Inc. 9c12e792-94c8-4e29-9a54-e7e70aadade6 2026-04-16 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 Eversmile Squirt 2.65% HYDROGEN PEROXIDE Everbrands, Inc. 6753b426-6d49-4438-a52f-c28e60a0e9d8 2026-04-16 Warnings Exact identifier application number: M021 Osstem S Sensitivity relief tooth POTASSIUM NITRATE, SODIUM FLUORIDE Osstem Pharma Co., Ltd 4f8ab179-8f29-a7cf-e063-6294a90a0c22 2026-04-15 Warnings Exact identifier unii: 8ZYQ1474W7 Osstem G Gum Health Care Tooth SODIUM FLUORIDE Osstem Pharma Co., Ltd 4f8b4fc0-4c98-5e52-e063-6394a90af710 2026-04-15 Warnings Exact identifier application number: M021 rxcui: 245598 unii: 8ZYQ1474W7 Crest 3D White Deep Stain Remover Enamel Strength SODIUM MONOFLUOROPHOSPHATE The Procter & Gamble Manufacturing Company 4f6b8851-c778-8abd-e063-6294a90aef4f 2026-04-14 Exact identifier application number: M021 Crest 3D White Stain Eraser Luxe Mint SODIUM FLUORIDE The Procter & Gamble Manufacturing Company 4f6beb3b-2521-bfb7-e063-6394a90ad9ea 2026-04-14 Exact identifier application number: M021 unii: 8ZYQ1474W7 Kids Crest Strawberry Rush SODIUM FLUORIDE The Procter & Gamble Manufacturing Company 6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d13 2026-04-14 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 Crest Pro-Health Mouthwash Multi-Protection Strong Mint SODIUM FLUORIDE The Procter & Gamble Manufacturing Company 4f6d11b2-5aa2-ab34-e063-6294a90ac0bc 2026-04-14 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.