DT Whitening Anticavity Fluoride

Product NDC
50523-740
11-digit product format
505230740
Labeler code
50523
Product ID
50523-740_65569e7e-ac7f-a7bf-e053-2991aa0adba4
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 productproduct50523-740IInactivated by FDA2026-10-15
excluded packagepackage50523-74050523-740-64IInactivated by FDA2026-10-15

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 packagepackage50523-740-64d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50523-740-64f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50523-740-642ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50523-740-64a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50523-740-64cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50523-740-64cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50523-740-64302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50523-740-64ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50523-740-640efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50523-740-64ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50523-740-64367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50523-740-64557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50523-740-648af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50523-740-64834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50523-740-641332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50523-740-64fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50523-740-6486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50523-740-64bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50523-740-648dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50523-740-64e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50523-740-649bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50523-740-642020-01-31C16284748780-19d75b9d0-3c64-f424-e053-dadaa90a57ceDT WHITENING ANTICAVITY FLUORIDE TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50523-740-64DT Whitening Anticavity Fluoride1 in 1 BOXPASTE, DENTIFRICE17
50523-740-64DT Whitening Anticavity Fluoride181 g in 1 TUBEPASTE, DENTIFRICE1817

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QDT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
FLUORIDE IONACTIVE MOIETYQ80VPU408ODT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JDT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKDT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9DT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4DT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MDT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56DT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
SORBITOLINACTIVE INGREDIENT506T60A25RDT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RDT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50523-740DT WHITENING ANTICAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [VOLUME DISTRIBUTORS, INC.]7Legacy NDC, 2 package rows20180216_1387a589-9114-4eb8-85c6-4f359dc3fdc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1387a589-9114-4eb8-85c6-4f359dc3fdc87
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1387a589-9114-4eb8-85c6-4f359dc3fdc87
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1387a589-9114-4eb8-85c6-4f359dc3fdc87
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1387a589-9114-4eb8-85c6-4f359dc3fdc87
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1387a589-9114-4eb8-85c6-4f359dc3fdc87
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1387a589-9114-4eb8-85c6-4f359dc3fdc87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50523-740-64505230740641 in 1 BOXHistorical