FDA.reportPublic FDA data

Colgate Max Fresh Cool Mint

Product NDC
65954-564
11-digit product format
659540564
Labeler code
65954
Product ID
65954-564_8b315a60-178a-4fc2-90c6-402681348713
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
2008-04-06
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 Max Fresh Cool Mint
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
65954-564-81Colgate Max Fresh Cool Mint130 g in 1 BOTTLEGEL, DENTIFRICE1305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
METHYLCELLULOSE (100 MPA.S)INACTIVE INGREDIENT4GFU244C4JCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOLGATE MAX FRESH COOL MINT (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
65954-564COLGATE MAX FRESH COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [MISSION HILLS S.A DE C.V]5Current NDC, Legacy NDC, 1 package rows20241101_93c443bd-bb73-40a7-bdb0-0d7283220e39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN93c443bd-bb73-40a7-bdb0-0d7283220e395
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD93c443bd-bb73-40a7-bdb0-0d7283220e395
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY93c443bd-bb73-40a7-bdb0-0d7283220e395
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY93c443bd-bb73-40a7-bdb0-0d7283220e395
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY93c443bd-bb73-40a7-bdb0-0d7283220e395

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-564-8165954056481130 g in 1 BOTTLE (65954-564-81) 130 g2008-04-06NoNoHistorical