FDA.reportPublic FDA data

COLGATE KIDS WATERMELON FLAVOR

Product NDC
65954-036
11-digit product format
659540036
Labeler code
65954
Product ID
65954-036_83da9a46-9295-4dc2-adf7-9e7c298d4812
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
2011-07-26
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 KIDS WATERMELON FLAVOR
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
65954-036-81COLGATE KIDS WATERMELON FLAVOR130 g in 1 BOTTLEGEL, DENTIFRICE1304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCOLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MCOLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZCOLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-036COLGATE KIDS WATERMELON FLAVOR (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4Current NDC, Legacy NDC, 1 package rows20241020_a9057e2a-a185-42e4-97ad-754da818deda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNa9057e2a-a185-42e4-97ad-754da818deda4
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDa9057e2a-a185-42e4-97ad-754da818deda4
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYa9057e2a-a185-42e4-97ad-754da818deda4
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYa9057e2a-a185-42e4-97ad-754da818deda4
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYa9057e2a-a185-42e4-97ad-754da818deda4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-036-8165954003681130 g in 1 BOTTLE (65954-036-81) 130 g2011-07-26NoNoCurrent