FDA.reportPublic FDA data

Colgate Junior Bubble Fruit

Product NDC
65954-327
11-digit product format
659540327
Labeler code
65954
Product ID
65954-327_fbabcff0-6af0-45d2-b14c-ab7af932efb5
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate Junior Bubble Fruit
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
65954-327-20Colgate Junior Bubble Fruit24 g in 1 TUBEGEL, DENTIFRICE2411
65954-327-20Colgate Junior Bubble Fruit1 in 1 CARTONGEL, DENTIFRICE111
65954-327-45Colgate Junior Bubble Fruit2 in 1 CARTONGEL, DENTIFRICE211
65954-327-45Colgate Junior Bubble Fruit130 g in 1 TUBEGEL, DENTIFRICE13011
65954-327-46Colgate Junior Bubble Fruit130 g in 1 TUBEGEL, DENTIFRICE13011
65954-327-46Colgate Junior Bubble Fruit1 in 1 CARTONGEL, DENTIFRICE111
65954-327-59Colgate Junior Bubble Fruit1 in 1 CARTONGEL, DENTIFRICE111
65954-327-59Colgate Junior Bubble Fruit76 g in 1 TUBEGEL, DENTIFRICE7611

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311COLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
MICAINACTIVE INGREDIENTV8A1AW0880COLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-327COLGATE JUNIOR BUBBLE FRUIT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]10Current NDC, Legacy NDC, 8 package rows20250328_be965c17-a82a-4d03-b30d-dcee6da6204c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSNbe965c17-a82a-4d03-b30d-dcee6da6204c11
416783sodium fluoride 0.0024 MG/MG ToothpasteSCDbe965c17-a82a-4d03-b30d-dcee6da6204c11
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSYbe965c17-a82a-4d03-b30d-dcee6da6204c11
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYbe965c17-a82a-4d03-b30d-dcee6da6204c11
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYbe965c17-a82a-4d03-b30d-dcee6da6204c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-327-20659540327201 TUBE in 1 CARTON (65954-327-20) / 24 g in 1 TUBE1 tube2016-11-11NoNoCurrent
65954-327-45659540327452 TUBE in 1 CARTON (65954-327-45) / 130 g in 1 TUBE2 tube2024-01-01NoNoCurrent
65954-327-4665954032746130 g in 1 TUBE130 gHistorical
65954-327-59659540327591 TUBE in 1 CARTON (65954-327-59) / 76 g in 1 TUBE1 tube2016-11-11NoNoCurrent