FDA.reportPublic FDA data

Colgate Sensitive Prevent and Repair

Product NDC
35000-128
11-digit product format
350000128
Labeler code
35000
Product ID
35000-128_6716d55f-b6a4-451d-9040-9f5657f00b38
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE and SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-25
Marketing end
2027-12-31
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.1 mg/g; mg/g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colgate Sensitive Prevent and Repair

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-128-60Colgate Sensitive Prevent and Repair1 in 1 CARTONPASTE, DENTIFRICE16
35000-128-60Colgate Sensitive Prevent and Repair170 g in 1 TUBEPASTE, DENTIFRICE1706

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-128COLGATE SENSITIVE PREVENT AND REPAIR (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]5Current NDC, Legacy NDC, 2 package rows20240113_e67410dc-a671-4611-8af1-097be071cd1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNe67410dc-a671-4611-8af1-097be071cd1c6
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDe67410dc-a671-4611-8af1-097be071cd1c6
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYe67410dc-a671-4611-8af1-097be071cd1c6
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYe67410dc-a671-4611-8af1-097be071cd1c6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYe67410dc-a671-4611-8af1-097be071cd1c6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYe67410dc-a671-4611-8af1-097be071cd1c6
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYe67410dc-a671-4611-8af1-097be071cd1c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-128-60350000128601 TUBE in 1 CARTON (35000-128-60) / 170 g in 1 TUBE1 tube2019-10-252027-12-31NoNoCurrent