FDA.reportPublic FDA data

Sodium fluoride

Product NDC
65517-2000
11-digit product format
655172000
Labeler code
65517
Product ID
65517-2000_736662e7-6fe5-24d4-e053-2991aa0ac9ba
Type
HUMAN OTC DRUG
Nonproprietary name
Toothpaste
Dosage form
CREAM
Route
ORAL
Labeler
DUKAL CORPORATION
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-11-13
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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65517-2000DDiscontinued by firm2026-10-02
excluded packagepackage65517-200065517-2000-0DDiscontinued by firm2026-10-02
excluded packagepackage65517-200065517-2000-1DDiscontinued by firm2026-10-02
excluded packagepackage65517-200065517-2000-2DDiscontinued by firm2026-10-02
excluded packagepackage65517-200065517-2000-3DDiscontinued by firm2026-10-02
excluded packagepackage65517-200065517-2000-4DDiscontinued by firm2026-10-02
excluded packagepackage65517-200065517-2000-5DDiscontinued by firm2026-10-02
excluded packagepackage65517-200065517-2000-6DDiscontinued by firm2026-10-02
excluded packagepackage65517-200065517-2000-7DDiscontinued by firm2026-10-02

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
65517-2000-0DAWNMIST TOOTHPASTE
65517-2000-1DAWNMIST TOOTHPASTE
65517-2000-2DAWNMIST TOOTHPASTE
65517-2000-3DAWNMIST TOOTHPASTE
65517-2000-4DAWNMIST TOOTHPASTE
65517-2000-5DAWNMIST TOOTHPASTE
65517-2000-6DAWNMIST TOOTHPASTE
65517-2000-7DAWNMIST TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-2000-0Sodium fluoride17 g in 1 TUBECREAM176
65517-2000-1Sodium fluoride24 g in 1 TUBECREAM246
65517-2000-2Sodium fluoride42 g in 1 TUBECREAM426
65517-2000-3Sodium fluoride78 g in 1 TUBECREAM786
65517-2000-4Sodium fluoride1 in 1 BOXCREAM16
65517-2000-4Sodium fluoride42 g in 1 TUBECREAM426
65517-2000-5Sodium fluoride78 g in 1 TUBECREAM786
65517-2000-5Sodium fluoride1 in 1 BOXCREAM16
65517-2000-6Sodium fluoride135 g in 1 TUBECREAM1356
65517-2000-6Sodium fluoride1 in 1 BOXCREAM16
65517-2000-7Sodium fluoride181 g in 1 TUBECREAM1816
65517-2000-7Sodium fluoride1 in 1 BOXCREAM16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7SODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3ASODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
POTASSIUM NITRATEINACTIVE INGREDIENTRU45X2JN0ZSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
SORBITOLINACTIVE INGREDIENT506T60A25RSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-2000SODIUM FLUORIDE (TOOTHPASTE) CREAM [DUKAL LLC]6Legacy NDC, 12 package rows20240709_460c0f54-367a-4300-b066-5071d718ea73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN460c0f54-367a-4300-b066-5071d718ea736
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD460c0f54-367a-4300-b066-5071d718ea736
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY460c0f54-367a-4300-b066-5071d718ea736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65517-2000-06551720000017 g in 1 TUBE (65517-2000-0) 17 g2015-02-190000-00-00NoNoCurrent
65517-2000-16551720000124 g in 1 TUBE (65517-2000-1) 24 g2015-02-190000-00-00NoNoCurrent
65517-2000-26551720000242 g in 1 TUBE (65517-2000-2) 42 g2015-02-190000-00-00NoNoCurrent
65517-2000-36551720000378 g in 1 TUBE (65517-2000-3) 78 g2015-02-190000-00-00NoNoCurrent
65517-2000-4655172000041 TUBE in 1 BOX (65517-2000-4) > 42 g in 1 TUBE1 tube2015-02-190000-00-00NoNoCurrent
65517-2000-5655172000051 TUBE in 1 BOX (65517-2000-5) > 78 g in 1 TUBE1 tube2015-02-190000-00-00NoNoCurrent
65517-2000-6655172000061 TUBE in 1 BOX (65517-2000-6) > 135 g in 1 TUBE1 tube2015-02-190000-00-00NoNoCurrent
65517-2000-7655172000071 TUBE in 1 BOX (65517-2000-7) > 181 g in 1 TUBE1 tube2015-02-190000-00-00NoNoCurrent