FDA.reportPublic FDA data

Colgate

Product NDC
65954-768
11-digit product format
659540768
Labeler code
65954
Product ID
65954-768_3a8ad951-91ec-44d2-8be8-f8da4c26a975
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Mission Hills S.A de C.V
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-20
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
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
Brand name suffix
Baking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65954-768-35ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint170 g in 1 TUBEPASTE, DENTIFRICE17010
65954-768-35ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint3 in 1 CARTONPASTE, DENTIFRICE310
65954-768-60ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint1 in 1 CARTONPASTE, DENTIFRICE110
65954-768-60ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint170 g in 1 TUBEPASTE, DENTIFRICE17010
65954-768-64ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint1 in 1 CARTONPASTE, DENTIFRICE110
65954-768-64ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint181 g in 1 TUBEPASTE, DENTIFRICE18110
65954-768-69ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint113 g in 1 TUBEPASTE, DENTIFRICE11310
65954-768-69ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint1 in 1 CARTONPASTE, DENTIFRICE110
65954-768-82ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint1 in 1 CARTONPASTE, DENTIFRICE110
65954-768-82ColgateBaking Soda and Peroxide Whitening Oxygen Bubbles Frosty Mint232 g in 1 TUBEPASTE, DENTIFRICE23210

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QCOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
CALCIUM PEROXIDEINACTIVE INGREDIENT7FRO2ENO91COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJCOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOCOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-768COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]10Current NDC, Legacy NDC, 10 package rows20250321_d8aad36d-5537-4eaf-b9a3-75a9919f4d6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNd8aad36d-5537-4eaf-b9a3-75a9919f4d6e10
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDd8aad36d-5537-4eaf-b9a3-75a9919f4d6e10
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYd8aad36d-5537-4eaf-b9a3-75a9919f4d6e10
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYd8aad36d-5537-4eaf-b9a3-75a9919f4d6e10
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYd8aad36d-5537-4eaf-b9a3-75a9919f4d6e10
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYd8aad36d-5537-4eaf-b9a3-75a9919f4d6e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-768-35659540768353 TUBE in 1 CARTON (65954-768-35) / 170 g in 1 TUBE3 tube2024-01-01NoNoCurrent
65954-768-60659540768601 TUBE in 1 CARTON (65954-768-60) / 170 g in 1 TUBE1 tube2011-08-20NoNoCurrent
65954-768-64659540768641 in 1 CARTONHistorical
65954-768-69659540768691 TUBE in 1 CARTON (65954-768-69) / 113 g in 1 TUBE1 tube2011-08-20NoNoCurrent
65954-768-82659540768821 in 1 CARTONHistorical