FDA.reportPublic FDA data

Colgate Deep Clean Fluoride

Product NDC
65954-777
11-digit product format
659540777
Labeler code
65954
Product ID
65954-777_481354a0-b970-48da-8e5a-841d70ebe573
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Mission Hills S.A de C.V
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-29
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate Deep Clean Fluoride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui416783

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65954-777-58Colgate Deep Clean Fluoride70 g in 1 TUBEGEL, DENTIFRICE706
65954-777-58Colgate Deep Clean Fluoride1 in 1 CARTONGEL, DENTIFRICE16
65954-777-60Colgate Deep Clean Fluoride1 in 1 CARTONGEL, DENTIFRICE16
65954-777-60Colgate Deep Clean Fluoride170 g in 1 TUBEGEL, DENTIFRICE1706
65954-777-79Colgate Deep Clean Fluoride79 g in 1 TUBEGEL, DENTIFRICE796
65954-777-79Colgate Deep Clean Fluoride1 in 1 CARTONGEL, DENTIFRICE16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCOLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
MICAINACTIVE INGREDIENTV8A1AW0880COLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2COLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZCOLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-777COLGATE DEEP CLEAN FLUORIDE (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6Current NDC, Legacy NDC, 6 package rows20241127_3d788c69-d5a7-42d2-931d-59230eebbfab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN3d788c69-d5a7-42d2-931d-59230eebbfab6
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3d788c69-d5a7-42d2-931d-59230eebbfab6
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3d788c69-d5a7-42d2-931d-59230eebbfab6
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3d788c69-d5a7-42d2-931d-59230eebbfab6
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3d788c69-d5a7-42d2-931d-59230eebbfab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-777-58659540777581 TUBE in 1 CARTON (65954-777-58) / 70 g in 1 TUBE1 tube2015-01-29NoNoCurrent
65954-777-60659540777601 TUBE in 1 CARTON (65954-777-60) / 170 g in 1 TUBE1 tube2015-01-29NoNoCurrent
65954-777-796595407777979 g in 1 TUBE79 gHistorical