Colgate Advanced Whitening Fluoride

Product NDC
65954-778
11-digit product format
659540778
Labeler code
65954
Product ID
65954-778_a54216f5-6840-4f5e-b89b-80e3bb1659f6
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Mission Hills S.A de C.V
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-01-29
Marketing end
0000-00-00
Substance
SODIUM FLUORIDE
Active strength
1 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct65954-778DDiscontinued by firm2026-10-05
excluded packagepackage65954-77865954-778-58DDiscontinued by firm2026-10-05
excluded packagepackage65954-77865954-778-60DDiscontinued by firm2026-10-05
excluded packagepackage65954-77865954-778-79DDiscontinued by firm2026-10-05

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 · 48 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 packagepackage65954-778-79d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65954-778-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage65954-778-58d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65954-778-79f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65954-778-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65954-778-58f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65954-778-792ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65954-778-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage65954-778-582ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65954-778-79a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65954-778-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage65954-778-58a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65954-778-79cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65954-778-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage65954-778-58cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65954-778-79cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65954-778-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage65954-778-58cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65954-778-79302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65954-778-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage65954-778-58302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65954-778-79ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65954-778-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage65954-778-58ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65954-778-790efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65954-778-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage65954-778-580efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65954-778-79ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65954-778-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage65954-778-58ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65954-778-79367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65954-778-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage65954-778-58367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65954-778-79557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65954-778-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage65954-778-58557ba5c1ecfa…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
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311COLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCOLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
POTASSIUM PYROPHOSPHATEINACTIVE INGREDIENTB9W4019H5GCOLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICOLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM TRIPOLYPHOSPHATE ANHYDROUSINACTIVE INGREDIENT9SW4PFD2FZCOLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOLGATE ADVANCED WHITENING FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65954-778-58659540778581 TUBE in 1 CARTON (65954-778-58) > 70 g in 1 TUBE1 tube2015-01-290000-00-00NoNoCurrent
65954-778-60659540778601 TUBE in 1 CARTON (65954-778-60) > 170 g in 1 TUBE1 tube2015-01-290000-00-00NoNoCurrent
65954-778-79659540778791 TUBE in 1 CARTON (65954-778-79) > 79 g in 1 TUBE1 tube2015-01-290000-00-00NoNoCurrent