FDA.reportPublic FDA data

Colgate Sensitive Whitening

Product NDC
35000-131
11-digit product format
350000131
Labeler code
35000
Product ID
35000-131_12dc4fbb-69dc-449f-ba17-7c2f3723e726
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE and SODIUM FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.1 mg/g; 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 Sensitive Whitening
Listing expiration
2027-12-31

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
35000-131-34Colgate Sensitive Whitening170 g in 1 TUBEGEL, DENTIFRICE1701
35000-131-34Colgate Sensitive Whitening2 in 1 CARTONGEL, DENTIFRICE21
35000-131-46Colgate Sensitive Whitening1 in 1 CARTONGEL, DENTIFRICE11
35000-131-46Colgate Sensitive Whitening130 g in 1 TUBEGEL, DENTIFRICE1301
35000-131-60Colgate Sensitive Whitening1 in 1 CARTONGEL, DENTIFRICE11
35000-131-60Colgate Sensitive Whitening170 g in 1 TUBEGEL, DENTIFRICE1701

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN3b656928-af58-4ee9-8fb8-360688eb9bf31
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD3b656928-af58-4ee9-8fb8-360688eb9bf31
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY3b656928-af58-4ee9-8fb8-360688eb9bf31
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY3b656928-af58-4ee9-8fb8-360688eb9bf31
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3b656928-af58-4ee9-8fb8-360688eb9bf31
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3b656928-af58-4ee9-8fb8-360688eb9bf31
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY3b656928-af58-4ee9-8fb8-360688eb9bf31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-131-34350000131342 TUBE in 1 CARTON (35000-131-34) / 170 g in 1 TUBE2 tube2026-01-01NoNoCurrent
35000-131-46350000131461 TUBE in 1 CARTON (35000-131-46) / 130 g in 1 TUBE1 tube2026-01-01NoNoCurrent
35000-131-60350000131601 TUBE in 1 CARTON (35000-131-60) / 170 g in 1 TUBE1 tube2026-01-01NoNoCurrent