FDA.reportPublic FDA data

DawnMist Fluoride

Product NDC
65517-2018
Requested package NDC
65517-2018-0
11-digit product format
655172018
Labeler code
65517
Product ID
65517-2018_75d5f56a-24f8-5805-e053-2a91aa0aeadc
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Dukal Corporation
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-01-30
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65517-201865517-2018-0DDiscontinued by firm2026-08-17

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65517-2018-02024-01-30C16284748780-11030e365-6cd3-111a-e063-dadaa90a10e2DawnMist Fluoride Toothpaste

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7DAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL CORPORATION]1
FLUORIDE IONACTIVE MOIETYQ80VPU408ODAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL CORPORATION]1
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XDAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL CORPORATION]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33ADAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL CORPORATION]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL CORPORATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL CORPORATION]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL CORPORATION]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL CORPORATION]1
SORBITOLINACTIVE INGREDIENT506T60A25RDAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RDAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-2018DAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL LLC]4Legacy NDC20240709_3c0cbe62-3d3a-4040-ac37-7ca3a988b492.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65517-2018-06551720180017 g in 1 TUBE (65517-2018-0) 17 g2014-01-300000-00-00NoNoCurrent