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 33 of 111 · 2,214 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ECHINACEA ECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUS Marco Pharma International LLC. 7efadb70-99e4-428b-a8ef-a2797327c6fa 2026-01-12 Warnings Exact identifier unii: ETJ7Z6XBU4 ACT Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. 4ee6a478-afcf-4540-b427-ba08c942ccb3 2026-01-12 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 ACT Anticavity Fluoride Mint SODIUM FLUORIDE Chattem, Inc. e81c83a2-363a-442f-8731-2598a4f4c21e 2026-01-12 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. 258b78b4-55e7-410c-90f8-a3e456c02579 2026-01-12 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 ACT Total Care Dry Mouth Anticavity Mouth SODIUM FLUORIDE Chattem, Inc. 06684b82-aaa0-4ca6-8d56-4f9866269000 2026-01-12 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 ACT Anticavity Fluoride Kids Groovy Grape SODIUM FLUORIDE Chattem, Inc. cd167c0b-2086-4204-b0ac-90df404bd4bb 2026-01-12 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. beded786-bb55-4ba3-82fe-9e9d1b5e2979 2026-01-12 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 ACT Kids Pure Protect Anticavity- Simply Strawberry SODIUM FLUORIDE Chattem, Inc. 2fc80727-57c7-4a33-80e0-ab9f9487390d 2026-01-12 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 ACT Kids Anticavity Fluoride Groovy Grape SODIUM FLUORIDE Chattem, Inc. 310a3c11-1c66-4dac-99f4-5fdc15d0f77c 2026-01-12 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 ACT Anticavity Fluoride Kids Bubblegum SODIUM FLUORIDE Chattem, Inc. fbbccd58-a816-4a93-a658-f28246c11e80 2026-01-12 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 ACT Whitening Anticavity Gentle Mint SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION) Chattem, Inc. cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49 2026-01-12 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 ACT Restoring Anticavity Fluoride Cool Mint SODIUM FLUORIDE Chattem, Inc. ef63e193-5804-4b35-bae7-cad29cf4e8bc 2026-01-12 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 Prime Tooth Care Blueberry SODIUM FLUORIDE Prime Tooth Care LLC 86642110-4572-4b8b-88f1-8d25fe05701e 2026-01-09 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 Prime Tooth Care Juicy Peach SODIUM FLUORIDE Prime Tooth Care LLC 142f1610-3494-459f-a956-760e82169b87 2026-01-09 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 Prime Tooth Care Coconut Whip SODIUM FLUORIDE Prime Tooth Care LLC 55e95657-9415-4d9c-ac9b-d021aa14e64d 2026-01-09 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 Prime Tooth Care Hami Melon SODIUM FLUORIDE Prime Tooth Care LLC 0028f88d-a9fe-4cfa-a6c6-168f9689b5f6 2026-01-09 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 Prime Tooth Care Mango Smoothie SODIUM FLUORIDE Prime Tooth Care LLC 2f2cf851-2edc-4aaf-9083-c37bc58547de 2026-01-09 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 Prime Tooth Care Strawberries SODIUM FLUORIDE Prime Tooth Care LLC 7b4328bd-5d2d-40ca-8322-5e818e1babf9 2026-01-09 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 Prime Tooth Care Summer Watermelon SODIUM FLUORIDE Prime Tooth Care LLC b7c731a1-80e7-4571-a568-db0290a720c1 2026-01-09 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7 Kids Prime Pediatric Dental Group Anticavity for Kids SODIUM FLUORIDE Prime Tooth Care LLC 93259174-447d-4f7a-8e55-990eb8da5151 2026-01-09 Warnings Exact identifier application number: M021 unii: 8ZYQ1474W7
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.