FDA.reportPublic FDA data

Colgate Optic White Advanced Sparkling White

Product NDC
35000-978
11-digit product format
350000978
Labeler code
35000
Product ID
35000-978_c496921d-22c7-4ea6-a0ac-c9c42058bde1
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
2019-10-14
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 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 Sparkling White
Listing expiration
2027-12-31

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
35000-978-14Colgate Optic White Advanced Sparkling White1 in 1 CARTONPASTE, DENTIFRICE14
35000-978-14Colgate Optic White Advanced Sparkling White41 g in 1 TUBEPASTE, DENTIFRICE414
35000-978-16Colgate Optic White Advanced Sparkling White1 in 1 CARTONPASTE, DENTIFRICE14
35000-978-16Colgate Optic White Advanced Sparkling White21.2 g in 1 TUBEPASTE, DENTIFRICE21.24
35000-978-25Colgate Optic White Advanced Sparkling White70.8 g in 1 TUBEPASTE, DENTIFRICE70.84
35000-978-25Colgate Optic White Advanced Sparkling White1 in 1 CARTONPASTE, DENTIFRICE14
35000-978-32Colgate Optic White Advanced Sparkling White1 in 1 CARTONPASTE, DENTIFRICE14
35000-978-32Colgate Optic White Advanced Sparkling White90 g in 1 TUBEPASTE, DENTIFRICE904
35000-978-44Colgate Optic White Advanced Sparkling White127 g in 1 TUBEPASTE, DENTIFRICE1274
35000-978-44Colgate Optic White Advanced Sparkling White2 in 1 CARTONPASTE, DENTIFRICE24
35000-978-71Colgate Optic White Advanced Sparkling White119 g in 1 TUBEPASTE, DENTIFRICE1194
35000-978-71Colgate Optic White Advanced Sparkling White1 in 1 CARTONPASTE, DENTIFRICE14
35000-978-76Colgate Optic White Advanced Sparkling White90 g in 1 TUBEPASTE, DENTIFRICE904
35000-978-76Colgate Optic White Advanced Sparkling White2 in 1 CARTONPASTE, DENTIFRICE24
35000-978-86Colgate Optic White Advanced Sparkling White127 g in 1 TUBEPASTE, DENTIFRICE1274
35000-978-86Colgate Optic White Advanced Sparkling White1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-978COLGATE OPTIC WHITE ADVANCED SPARKLING WHITE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE PALMOLIVE COMPANY]3Current NDC, Legacy NDC, 16 package rows20241017_bc56603d-4190-48c1-b16e-3179a650cb39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNbc56603d-4190-48c1-b16e-3179a650cb394
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDbc56603d-4190-48c1-b16e-3179a650cb394
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYbc56603d-4190-48c1-b16e-3179a650cb394
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYbc56603d-4190-48c1-b16e-3179a650cb394
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYbc56603d-4190-48c1-b16e-3179a650cb394
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYbc56603d-4190-48c1-b16e-3179a650cb394

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-978-14350000978141 TUBE in 1 CARTON (35000-978-14) / 41 g in 1 TUBE1 tube2019-10-140000-00-00NoNoCurrent
35000-978-16350000978161 TUBE in 1 CARTON (35000-978-16) / 21.2 g in 1 TUBE1 tube2019-10-140000-00-00NoNoCurrent
35000-978-25350000978251 TUBE in 1 CARTON (35000-978-25) / 70.8 g in 1 TUBE1 tube2026-01-01NoNoCurrent
35000-978-32350000978321 TUBE in 1 CARTON (35000-978-32) / 90 g in 1 TUBE1 tube2019-10-140000-00-00NoNoCurrent
35000-978-44350000978442 TUBE in 1 CARTON (35000-978-44) / 127 g in 1 TUBE2 tube2019-10-140000-00-00NoNoCurrent
35000-978-71350000978711 TUBE in 1 CARTON (35000-978-71) / 119 g in 1 TUBE1 tube2019-11-260000-00-00NoNoCurrent
35000-978-76350000978762 TUBE in 1 CARTON (35000-978-76) / 90 g in 1 TUBE2 tube2019-10-140000-00-00NoNoCurrent
35000-978-86350000978861 TUBE in 1 CARTON (35000-978-86) / 127 g in 1 TUBE1 tube2019-10-140000-00-00NoNoCurrent