FDA.reportPublic FDA data

Sodium fluoride

Product NDC
65517-2000
11-digit product format
655172000
Labeler code
65517
Product ID
65517-2000_1cbd9395-3d74-b411-e063-6394a90afb29
Type
HUMAN OTC DRUG
Nonproprietary name
Toothpaste
Dosage form
CREAM
Route
ORAL
Labeler
DUKAL LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-13
Marketing end
2026-07-31
Substance
SODIUM FLUORIDE
Active strength
.22 g/100g
NDC exclude flag
No
Current FDA listing
Yes

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 firm2026-08-17
excluded packagepackage65517-200065517-2000-0DDiscontinued by firm2026-08-17
excluded packagepackage65517-200065517-2000-1DDiscontinued by firm2026-08-17
excluded packagepackage65517-200065517-2000-2DDiscontinued by firm2026-08-17
excluded packagepackage65517-200065517-2000-3DDiscontinued by firm2026-08-17
excluded packagepackage65517-200065517-2000-4DDiscontinued by firm2026-08-17
excluded packagepackage65517-200065517-2000-5DDiscontinued by firm2026-08-17
excluded packagepackage65517-200065517-2000-6DDiscontinued by firm2026-08-17
excluded packagepackage65517-200065517-2000-7DDiscontinued by firm2026-08-17

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]6Current NDC, Legacy NDC, 12 package rows20240709_460c0f54-367a-4300-b066-5071d718ea73.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 1 of 42 · 822 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)584b38ce-d1ef-4ecc-a887-7c96e7f9669f2026-08-20WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWalgreensfb93c7f6-e025-4cf2-9997-acfe9a0debdd2026-08-19WarningsExact identifier
application number: M022
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
application number: M022
Ludens Honey Licorice Throat DropsMENTHOLPrestige Brands Holdings, Inc.5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac2026-08-19WarningsExact identifier
application number: M022
Ludens Dual ReliefPECTIN AND MENTHOLPrestige Brands Holdings, Inc.d0213cb3-ec8e-40cc-82c9-694032f0490f2026-08-19WarningsExact identifier
application number: M022
CVS Health Sore Throat Fast Relief Oral AnestheticPHENOLCVS Pharmacy,Inc.4fb880db-2185-41ef-a5f9-8983a28d2c5b2026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat CherryPHENOLCVS Pharmacy,Inc.887c68e0-ff44-4bad-b360-56fb99ed9c452026-08-17WarningsExact identifier
application number: M022
CVS Sore Throat Menthol FlavorPHENOLCVS PHARMACY,INC.665be058-b965-4b78-80b0-dd85241809322026-08-17WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEHarris Teeter, LLC7e5f175d-f0d6-4665-ac14-1873d6b99c802026-08-12WarningsExact identifier
application number: M022
Gingicaine Gel Variety PakGINGICAINE GEL VARIETY PAKGingi-Pak a Division of the Belport62ed4ff3-18f6-5c67-e053-2991aa0a77922026-08-11WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 Percent ReadyInCaseHYDROGEN PEROXIDEP & L Development, LLCb0866db5-3b0d-4478-9b3b-1f077d2f53932026-08-06WarningsExact identifier
application number: M022
Ollie Fresh MintSODIUM FLUORIDE, POTASSIUM NITRATEBrio Product Group LLC.ebeec44f-3c22-43f2-9256-6ece6025c1052026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.5868c5a1-273f-f023-e063-6394a90ac9d82026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58690bb5-9604-26a4-e063-6394a90afdbe2026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586918cf-7b13-5999-e063-6294a90a88a92026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586924a0-322d-5dc3-e063-6294a90a15562026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.58692e90-de74-52d3-e063-6394a90a97022026-08-06WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINETop Quality Manufacturing, Inc.586937ae-46af-7066-e063-6294a90ae53e2026-08-06WarningsExact identifier
application number: M022
Freshness Blueberry Toothpaste100gFRESHNESS BLUEBERRY TOOTHPASTE 100GWORLD DENTISTS ASSOCIATION AMERICA LIMITED586d1dba-87fc-b676-e063-6294a90a14702026-08-06WarningsExact identifier
application number: M022

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 g2015-02-192026-07-31NoNoCurrent
65517-2000-16551720000124 g in 1 TUBE (65517-2000-1) 24 g2015-02-192026-07-31NoNoCurrent
65517-2000-26551720000242 g in 1 TUBE (65517-2000-2) 42 g2015-02-192026-07-31NoNoCurrent
65517-2000-36551720000378 g in 1 TUBE (65517-2000-3) 78 g2015-02-192026-07-31NoNoCurrent
65517-2000-4655172000041 TUBE in 1 BOX (65517-2000-4) / 42 g in 1 TUBE1 tube2015-02-192026-07-31NoNoCurrent
65517-2000-5655172000051 TUBE in 1 BOX (65517-2000-5) / 78 g in 1 TUBE1 tube2015-02-192026-07-14NoNoCurrent
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 tube2015-02-192026-07-31NoNoCurrent