COLGATE OPTIC WHITE PRO SERIES HI WHITE

Product NDC
65954-841
11-digit product format
659540841
Labeler code
65954
Product ID
65954-841_6c23d47d-bf4c-414e-9400-97674b2c2223
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Mission Hills, S.A. de C.V.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-21
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.5 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 OPTIC WHITE PRO SERIES HI WHITE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui1038995

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65954-841-63COLGATE OPTIC WHITE PRO SERIES HI WHITE1 in 1 CARTONPASTE, DENTIFRICE11
65954-841-63COLGATE OPTIC WHITE PRO SERIES HI WHITE85 g in 1 TUBEPASTE, DENTIFRICE851

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038995sodium monofluorophosphate 1.14 % ToothpastePSNa13c04f6-4a5a-4026-86b7-e8ee27eafcd81
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCDa13c04f6-4a5a-4026-86b7-e8ee27eafcd81
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSYa13c04f6-4a5a-4026-86b7-e8ee27eafcd81
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSYa13c04f6-4a5a-4026-86b7-e8ee27eafcd81
1038995sodium monofluorophosphate 1.14 % ToothpasteSYa13c04f6-4a5a-4026-86b7-e8ee27eafcd81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65954-841-63659540841631 TUBE in 1 CARTON (65954-841-63) / 85 g in 1 TUBE1 tube2025-10-21NoNoHistorical