FDA.reportPublic FDA data

Colgate Sensitive Pro Relief Enamel Repair

Product NDC
65954-553
11-digit product format
659540553
Labeler code
65954
Product ID
65954-553_3ae07621-1efd-4df6-a497-a17898ec044e
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE and POTASSIUM NITRATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Mission Hills S.A de C.V
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-01-12
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE; POTASSIUM NITRATE
Active strength
2 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZCOLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56QCOLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OCOLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
NITRATE IONACTIVE MOIETYT93E9Y2844COLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311COLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9COLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2COLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9COLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYCOLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4COLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICOLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCOLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM PHOSPHATE, TRIBASIC, MONOHYDRATEINACTIVE INGREDIENTJ9O85FKF29COLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZCOLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
SORBITOLINACTIVE INGREDIENT506T60A25RCOLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
WATERINACTIVE INGREDIENT059QF0KO0RCOLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECOLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR (SODIUM MONOFLUOROPHOSPHATE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [MISSION HILLS S.A DE C.V]2