FDA.reportPublic FDA data

Colgate Cavity Protection

Product NDC
65954-591
11-digit product format
659540591
Labeler code
65954
Product ID
65954-591_f75202bd-888d-47c5-9422-1965e66008b3
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
2014-04-06
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 Cavity Protection
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
65954-591-71Colgate Cavity Protection119 g in 1 TUBEGEL, DENTIFRICE1194

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE CAVITY PROTECTION (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE CAVITY PROTECTION (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311COLGATE CAVITY PROTECTION (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLGATE CAVITY PROTECTION (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MCOLGATE CAVITY PROTECTION (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE CAVITY PROTECTION (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE CAVITY PROTECTION (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE CAVITY PROTECTION (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE CAVITY PROTECTION (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE CAVITY PROTECTION (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE CAVITY PROTECTION (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
65954-591COLGATE CAVITY PROTECTION (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]4Current NDC, Legacy NDC, 1 package rows20241101_821987f3-16b9-43da-ab83-3e73f531c677.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN821987f3-16b9-43da-ab83-3e73f531c6774
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD821987f3-16b9-43da-ab83-3e73f531c6774
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY821987f3-16b9-43da-ab83-3e73f531c6774
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY821987f3-16b9-43da-ab83-3e73f531c6774
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY821987f3-16b9-43da-ab83-3e73f531c6774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-591-7165954059171119 g in 1 TUBE (65954-591-71) 119 g2014-04-06NoNoCurrent