FDA.reportPublic FDA data

Colgate

Product NDC
65954-063
11-digit product format
659540063
Labeler code
65954
Product ID
65954-063_8b2f9055-c421-4b70-a67c-f5fca520ef03
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
2011-12-01
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.1 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate
Brand name suffix
ULTRA BRITE Baking Soda and Peroxide Whitening
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65954-063-60ColgateULTRA BRITE Baking Soda and Peroxide Whitening170 g in 1 TUBEPASTE, DENTIFRICE1707
65954-063-60ColgateULTRA BRITE Baking Soda and Peroxide Whitening1 in 1 CARTONPASTE, DENTIFRICE17
65954-063-71ColgateULTRA BRITE Baking Soda and Peroxide Whitening1 in 1 CARTONPASTE, DENTIFRICE17
65954-063-71ColgateULTRA BRITE Baking Soda and Peroxide Whitening119 g in 1 TUBEPASTE, DENTIFRICE1197

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QCOLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
CALCIUM PEROXIDEINACTIVE INGREDIENT7FRO2ENO91COLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311COLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJCOLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYCOLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOCOLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICOLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-063COLGATE ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MISSION HILLS, S.A. DE C.V.]5Current NDC, Legacy NDC, 4 package rows20241020_a955bf24-0625-48c5-b869-def75a7e332a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNa955bf24-0625-48c5-b869-def75a7e332a7
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDa955bf24-0625-48c5-b869-def75a7e332a7
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYa955bf24-0625-48c5-b869-def75a7e332a7
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYa955bf24-0625-48c5-b869-def75a7e332a7
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYa955bf24-0625-48c5-b869-def75a7e332a7
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYa955bf24-0625-48c5-b869-def75a7e332a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-063-60659540063601 TUBE in 1 CARTON (65954-063-60) / 170 g in 1 TUBE1 tube2011-12-01NoNoHistorical
65954-063-71659540063711 TUBE in 1 CARTON (65954-063-71) / 119 g in 1 TUBE1 tube2026-03-01NoNoHistorical