COLGATE OPTIC WHITE PRO SERIES

Product NDC
35000-791
11-digit product format
350000791
Labeler code
35000
Product ID
35000-791_c8d6fb8e-f272-4b0d-b1b9-953b58d4ffd1
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-24
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
11.4 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 PRO SERIES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE11.4 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui1038995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-791-62COLGATE OPTIC WHITE PRO SERIES2 in 1 CARTONPASTE, DENTIFRICE21
35000-791-62COLGATE OPTIC WHITE PRO SERIES85 g in 1 TUBEPASTE, DENTIFRICE851
35000-791-63COLGATE OPTIC WHITE PRO SERIES85 g in 1 TUBEPASTE, DENTIFRICE851
35000-791-63COLGATE OPTIC WHITE PRO SERIES1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038995sodium monofluorophosphate 1.14 % ToothpastePSNcd954777-697a-4cc7-8f5f-b2caf357ef951
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCDcd954777-697a-4cc7-8f5f-b2caf357ef951
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSYcd954777-697a-4cc7-8f5f-b2caf357ef951
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSYcd954777-697a-4cc7-8f5f-b2caf357ef951
1038995sodium monofluorophosphate 1.14 % ToothpasteSYcd954777-697a-4cc7-8f5f-b2caf357ef951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-791-62350000791622 TUBE in 1 CARTON (35000-791-62) / 85 g in 1 TUBE2 tube2025-11-24NoNoCurrent
35000-791-63350000791631 TUBE in 1 CARTON (35000-791-63) / 85 g in 1 TUBE1 tube2025-11-24NoNoCurrent