FDA.reportPublic FDA data

DAWNMIST FLUORIDE

Product NDC
65517-2017
11-digit product format
655172017
Labeler code
65517
Product ID
65517-2017_1cc350a2-ca04-be5f-e063-6294a90a63f1
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE
Route
DENTAL
Labeler
Dukal LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-17
Marketing end
2026-07-25
Substance
SODIUM FLUORIDE
Active strength
.22 g/100g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DAWNMIST FLUORIDE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.22 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui245598

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65517-2017-02024-01-30C16284748780-11030e364-fd8e-111a-e063-dadaa90a10e2DawnMist Gel Fluoride Toothpaste
65517-2017-12024-01-30C16284748780-11030e364-fd8e-111a-e063-dadaa90a10e2DawnMist Gel Fluoride Toothpaste
65517-2017-22024-01-30C16284748780-11030e364-fd8e-111a-e063-dadaa90a10e2DawnMist Gel Fluoride Toothpaste
65517-2017-32024-01-30C16284748780-11030e364-fd8e-111a-e063-dadaa90a10e2DawnMist 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]5Current NDC, Legacy 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
65517-2017-06551720170078 g in 1 TUBE (65517-2017-0) 78 g2017-07-142026-06-12NoNoCurrent
65517-2017-16551720170117 g in 1 TUBE (65517-2017-1) 17 g2017-07-142026-07-25NoNoCurrent
65517-2017-26551720170224 g in 1 TUBE (65517-2017-2) 24 g2017-07-142026-07-25NoNoCurrent
65517-2017-36551720170343 g in 1 TUBE (65517-2017-3) 43 g2017-07-142026-07-25NoNoCurrent