FDA.reportPublic FDA data

Colgate Kids

Product NDC
65954-065
11-digit product format
659540065
Labeler code
65954
Product ID
65954-065_6180cad9-b774-4bce-a89b-9aedf1dfa14d
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
2016-11-11
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate Kids
Brand name suffix
Mild Bubble Fruit Flavor
Listing expiration
2027-12-31

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
65954-065-46Colgate KidsMild Bubble Fruit Flavor130 g in 1 TUBEGEL, DENTIFRICE13019
65954-065-93Colgate KidsMild Bubble Fruit Flavor99 g in 1 TUBEGEL, DENTIFRICE9919

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE KIDS MILD BUBBLE FRUIT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE KIDS MILD BUBBLE FRUIT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311COLGATE KIDS MILD BUBBLE FRUIT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLGATE KIDS MILD BUBBLE FRUIT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE KIDS MILD BUBBLE FRUIT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
MICAINACTIVE INGREDIENTV8A1AW0880COLGATE KIDS MILD BUBBLE FRUIT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE KIDS MILD BUBBLE FRUIT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE KIDS MILD BUBBLE FRUIT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE KIDS MILD BUBBLE FRUIT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE KIDS MILD BUBBLE FRUIT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLGATE KIDS MILD BUBBLE FRUIT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE KIDS MILD BUBBLE FRUIT FLAVOR (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
65954-065COLGATE KIDS MILD BUBBLE FRUIT FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]16Current NDC, Legacy NDC, 2 package rows20241219_39247381-c565-4e43-8174-f3d9a58b4625.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN39247381-c565-4e43-8174-f3d9a58b462519
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD39247381-c565-4e43-8174-f3d9a58b462519
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY39247381-c565-4e43-8174-f3d9a58b462519
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY39247381-c565-4e43-8174-f3d9a58b462519
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY39247381-c565-4e43-8174-f3d9a58b462519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-065-4665954006546130 g in 1 TUBE (65954-065-46) 130 g2020-05-05NoNoHistorical
65954-065-936595400659399 g in 1 TUBE (65954-065-93) 99 g2025-01-01NoNoHistorical