FDA.reportPublic FDA data

DAWNMIST FLUORIDE

Product NDC
65517-2017
Requested package NDC
65517-2017-1
11-digit product format
655172017
Labeler code
65517
Product ID
65517-2017_7309e82b-f350-16bf-e053-2991aa0a6c49
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
2014-01-17
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
0 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 packagepackage65517-201765517-2017-1DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
65517-2017-0DawnMist Gel Fluoride Toothpaste
65517-2017-1DawnMist Gel Fluoride Toothpaste
65517-2017-2DawnMist Gel Fluoride Toothpaste
65517-2017-3DawnMist Gel Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-2017-0DAWNMIST FLUORIDE78 g in 1 TUBEPASTE785
65517-2017-1DAWNMIST FLUORIDE17 g in 1 TUBEPASTE175
65517-2017-2DAWNMIST FLUORIDE24 g in 1 TUBEPASTE245
65517-2017-3DAWNMIST FLUORIDE43 g in 1 TUBEPASTE435

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
WATERINACTIVE INGREDIENT059QF0KO0RDAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-2017DAWNMIST FLUORIDE (SODIUM FLUORIDE) PASTE [DUKAL LLC]5Legacy NDC, 4 package rows20240709_3cd621bd-15aa-4c81-8734-91ccc929b4d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN3cd621bd-15aa-4c81-8734-91ccc929b4d65
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD3cd621bd-15aa-4c81-8734-91ccc929b4d65
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY3cd621bd-15aa-4c81-8734-91ccc929b4d65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65517-2017-16551720170117 g in 1 TUBE (65517-2017-1) 17 g2017-07-140000-00-00NoNoCurrent