Colgate Optic White Stain Prevention

Product NDC
35000-893
11-digit product format
350000893
Labeler code
35000
Product ID
35000-893_8dc87f0b-e5e8-4f40-bcaf-01be95ae9138
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
2022-01-07
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 Stain Prevention
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-893-41Colgate Optic White Stain Prevention116 g in 1 TUBEPASTE, DENTIFRICE1164
35000-893-41Colgate Optic White Stain Prevention1 in 1 CARTONPASTE, DENTIFRICE14
35000-893-43Colgate Optic White Stain Prevention121 g in 1 TUBEPASTE, DENTIFRICE1214
35000-893-43Colgate Optic White Stain Prevention1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-893COLGATE OPTIC WHITE STAIN PREVENTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]4Current NDC, Legacy NDC, 4 package rows20241215_d1350584-31cc-4cfb-bfcd-b07ff7e087d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNd1350584-31cc-4cfb-bfcd-b07ff7e087d04
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDd1350584-31cc-4cfb-bfcd-b07ff7e087d04
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYd1350584-31cc-4cfb-bfcd-b07ff7e087d04
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYd1350584-31cc-4cfb-bfcd-b07ff7e087d04
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYd1350584-31cc-4cfb-bfcd-b07ff7e087d04
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYd1350584-31cc-4cfb-bfcd-b07ff7e087d04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-893-41350000893411 TUBE in 1 CARTON (35000-893-41) / 116 g in 1 TUBE1 tube2022-01-07NoNoHistorical
35000-893-43350000893431 TUBE in 1 CARTON (35000-893-43) > 121 g in 1 TUBE1 tube2022-01-070000-00-00NoNoCurrent