COLGATE OPTIC WHITE RELIEF

Product NDC
65954-834
11-digit product format
659540834
Labeler code
65954
Product ID
65954-834_04c76ae0-57c0-49e0-99a2-b6e4d0bd554d
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Mission Hills S.A de C.V
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-25
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.5 mg/g; 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 OPTIC WHITE RELIEF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65954-834-59COLGATE OPTIC WHITE RELIEF1 in 1 CARTONPASTE, DENTIFRICE11
65954-834-59COLGATE OPTIC WHITE RELIEF107 g in 1 TUBEPASTE, DENTIFRICE1071

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNde4904c0-5709-4815-87f3-589a0f1df9e21
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDde4904c0-5709-4815-87f3-589a0f1df9e21
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYde4904c0-5709-4815-87f3-589a0f1df9e21
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYde4904c0-5709-4815-87f3-589a0f1df9e21
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYde4904c0-5709-4815-87f3-589a0f1df9e21
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYde4904c0-5709-4815-87f3-589a0f1df9e21
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYde4904c0-5709-4815-87f3-589a0f1df9e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-834-59659540834591 TUBE in 1 CARTON (65954-834-59) / 107 g in 1 TUBE1 tube2025-09-25NoNoCurrent