Iodent Sensitive Extra Whitening

Product NDC
65923-105
11-digit product format
659230105
Labeler code
65923
Product ID
65923-105_690a2f72-4716-6a96-e053-2a91aa0abb36
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride Potassium Nitrate
Dosage form
PASTE
Route
DENTAL
Labeler
United Exchange Corp.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-10-23
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
5 mg/g; mg/g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65923-105DDiscontinued by firm2026-10-15
excluded packagepackage65923-10565923-105-04DDiscontinued by firm2026-10-15

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 · 24 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 packagepackage65923-105-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65923-105-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65923-105-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65923-105-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65923-105-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65923-105-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65923-105-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65923-105-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65923-105-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65923-105-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65923-105-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65923-105-04557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZIODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7IODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3
FLUORIDE IONACTIVE MOIETYQ80VPU408OIODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3
NITRATE IONACTIVE MOIETYT93E9Y2844IODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311IODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9IODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3
PEG/PPG-116/66 COPOLYMERINACTIVE INGREDIENTJP0CK963E0IODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQIODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYIODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZIODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3
SORBITOLINACTIVE INGREDIENT506T60A25RIODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RIODENT SENSITIVE EXTRA WHITENING (SODIUM FLUORIDE POTASSIUM NITRATE) PASTE [UNITED EXCHANGE CORP.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65923-105-04659230105041 TUBE in 1 CARTON (65923-105-04) > 113 g in 1 TUBE1 tube2016-12-210000-00-00NoNoCurrent