COLGATE OPTIC WHITE ADVANCED ENAMEL STRENGTH

Product NDC
35000-921
11-digit product format
350000921
Labeler code
35000
Product ID
35000-921_7a46cc15-ac06-4d1f-bcc4-097f205ff0be
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-01
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 ADVANCED ENAMEL STRENGTH
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
35000-921-32COLGATE OPTIC WHITE ADVANCED ENAMEL STRENGTH90 g in 1 TUBEPASTE, DENTIFRICE901
35000-921-32COLGATE OPTIC WHITE ADVANCED ENAMEL STRENGTH1 in 1 CARTONPASTE, DENTIFRICE11
35000-921-58COLGATE OPTIC WHITE ADVANCED ENAMEL STRENGTH70.8 g in 1 TUBEPASTE, DENTIFRICE70.81
35000-921-58COLGATE OPTIC WHITE ADVANCED ENAMEL STRENGTH1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038995sodium monofluorophosphate 1.14 % ToothpastePSN358842de-3e1d-4f66-8d08-fe8538441b341
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCD358842de-3e1d-4f66-8d08-fe8538441b341
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSY358842de-3e1d-4f66-8d08-fe8538441b341
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSY358842de-3e1d-4f66-8d08-fe8538441b341
1038995sodium monofluorophosphate 1.14 % ToothpasteSY358842de-3e1d-4f66-8d08-fe8538441b341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35000-921-32350000921321 TUBE in 1 CARTON (35000-921-32) / 90 g in 1 TUBE1 tube2026-03-01NoNoHistorical
35000-921-58350000921581 TUBE in 1 CARTON (35000-921-58) / 70.8 g in 1 TUBE1 tube2026-03-01NoNoHistorical