DT Fluoride

Product NDC
50523-739
11-digit product format
505230739
Labeler code
50523
Product ID
50523-739_65564938-5b53-4c16-e053-2991aa0a2b6b
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Volume Distributors, Inc.
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-07-22
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
0 g/100g
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50523-739IInactivated by FDA2026-10-05
excluded packagepackage50523-73950523-739-64IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50523-739-64d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50523-739-64f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50523-739-642ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50523-739-64a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50523-739-64cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50523-739-64cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50523-739-64302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50523-739-64ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50523-739-640efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50523-739-64ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50523-739-64367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50523-739-64557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50523-739-648af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50523-739-64834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50523-739-641332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50523-739-64fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50523-739-6486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50523-739-64bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50523-739-648dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50523-739-64e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50523-739-649bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50523-739-642020-01-31C16284748780-19d75b9d0-6895-f424-e053-dadaa90a57ceDT FLUORIDE TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50523-739-64DT Fluoride181 g in 1 TUBEPASTE, DENTIFRICE1816
50523-739-64DT Fluoride1 in 1 BOXPASTE, DENTIFRICE16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QDT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
FLUORIDE IONACTIVE MOIETYQ80VPU408ODT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JDT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKDT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
CARBOXYMETHYLCELLULOSEINACTIVE INGREDIENT05JZI7B19XDT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9DT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4DT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
SORBITOLINACTIVE INGREDIENT506T60A25RDT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RDT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50523-739DT FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6Legacy NDC, 2 package rows20180216_cefd65ab-dcce-4359-b33b-d3084589ecd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNcefd65ab-dcce-4359-b33b-d3084589ecd26
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDcefd65ab-dcce-4359-b33b-d3084589ecd26
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYcefd65ab-dcce-4359-b33b-d3084589ecd26
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYcefd65ab-dcce-4359-b33b-d3084589ecd26
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYcefd65ab-dcce-4359-b33b-d3084589ecd26
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYcefd65ab-dcce-4359-b33b-d3084589ecd26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50523-739-6450523073964181 g in 1 TUBE181 gHistorical