Colgate Optic White Renewal High Impact White

Product NDC
35000-982
11-digit product format
350000982
Labeler code
35000
Product ID
35000-982_5f8d57ef-2ba3-45a4-a783-e65dff284cc9
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
2019-11-04
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 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 Renewal High Impact White
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

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
35000-982-15Colgate Optic White Renewal High Impact White1 in 1 CARTONPASTE, DENTIFRICE18
35000-982-15Colgate Optic White Renewal High Impact White20 g in 1 TUBEPASTE, DENTIFRICE208
35000-982-41Colgate Optic White Renewal High Impact White116 g in 1 TUBEPASTE, DENTIFRICE1168
35000-982-41Colgate Optic White Renewal High Impact White1 in 1 CARTONPASTE, DENTIFRICE18
35000-982-43Colgate Optic White Renewal High Impact White121 g in 1 TUBEPASTE, DENTIFRICE1218
35000-982-43Colgate Optic White Renewal High Impact White1 in 1 CARTONPASTE, DENTIFRICE18
35000-982-62Colgate Optic White Renewal High Impact White85 g in 1 TUBEPASTE, DENTIFRICE858
35000-982-62Colgate Optic White Renewal High Impact White2 in 1 CARTONPASTE, DENTIFRICE28
35000-982-63Colgate Optic White Renewal High Impact White1 in 1 CARTONPASTE, DENTIFRICE18
35000-982-63Colgate Optic White Renewal High Impact White85 g in 1 TUBEPASTE, DENTIFRICE858

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-982COLGATE OPTIC WHITE RENEWAL HIGH IMPACT WHITE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]7Current NDC, Legacy NDC, 10 package rows20241206_0b90a131-7933-4501-a174-e35aa95b56c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN0b90a131-7933-4501-a174-e35aa95b56c38
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD0b90a131-7933-4501-a174-e35aa95b56c38
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY0b90a131-7933-4501-a174-e35aa95b56c38
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY0b90a131-7933-4501-a174-e35aa95b56c38
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY0b90a131-7933-4501-a174-e35aa95b56c38
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY0b90a131-7933-4501-a174-e35aa95b56c38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-982-15350000982151 TUBE in 1 CARTON (35000-982-15) > 20 g in 1 TUBE1 tube2019-12-130000-00-00NoNoCurrent
35000-982-41350000982411 TUBE in 1 CARTON (35000-982-41) / 116 g in 1 TUBE1 tube2020-03-130000-00-00NoNoCurrent
35000-982-43350000982431 TUBE in 1 CARTON (35000-982-43) > 121 g in 1 TUBE1 tube2022-04-040000-00-00NoNoCurrent
35000-982-62350000982622 TUBE in 1 CARTON (35000-982-62) > 85 g in 1 TUBE2 tube2019-11-040000-00-00NoNoCurrent
35000-982-63350000982631 TUBE in 1 CARTON (35000-982-63) > 85 g in 1 TUBE1 tube2019-11-040000-00-00NoNoCurrent