FDA.reportPublic FDA data

COLGATE SPARKLING WHITE CINNAMINT

Product NDC
65954-008
11-digit product format
659540008
Labeler code
65954
Product ID
65954-008_82a712a6-e1bc-4fdd-abc0-8a7eb7350800
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
2012-10-01
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 SPARKLING WHITE CINNAMINT
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
65954-008-60COLGATE SPARKLING WHITE CINNAMINT170 g in 1 TUBEGEL, DENTIFRICE1706
65954-008-60COLGATE SPARKLING WHITE CINNAMINT1 in 1 CARTONGEL, DENTIFRICE16
65954-008-64COLGATE SPARKLING WHITE CINNAMINT181 g in 1 TUBEGEL, DENTIFRICE1816
65954-008-64COLGATE SPARKLING WHITE CINNAMINT1 in 1 CARTONGEL, DENTIFRICE16
65954-008-69COLGATE SPARKLING WHITE CINNAMINT113 g in 1 TUBEGEL, DENTIFRICE1136
65954-008-69COLGATE SPARKLING WHITE CINNAMINT1 in 1 CARTONGEL, DENTIFRICE16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311COLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCOLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
MICAINACTIVE INGREDIENTV8A1AW0880COLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZCOLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE SPARKLING WHITE CINNAMINT (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
65954-008COLGATE SPARKLING WHITE CINNAMINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]6Current NDC, Legacy NDC, 6 package rows20241127_f604401a-1db6-41f8-9da3-995fa6faf5e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNf604401a-1db6-41f8-9da3-995fa6faf5e56
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDf604401a-1db6-41f8-9da3-995fa6faf5e56
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYf604401a-1db6-41f8-9da3-995fa6faf5e56
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYf604401a-1db6-41f8-9da3-995fa6faf5e56
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYf604401a-1db6-41f8-9da3-995fa6faf5e56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-008-6065954000860170 g in 1 TUBE170 gHistorical
65954-008-6465954000864181 g in 1 TUBE181 gHistorical
65954-008-69659540008691 TUBE in 1 CARTON (65954-008-69) / 113 g in 1 TUBE1 tube2012-10-01NoNoHistorical