FDA.reportPublic FDA data

Colgate Optic White Advanced Vibrant Clean

Product NDC
35000-979
Requested package NDC
35000-979-76
11-digit product format
350000979
Labeler code
35000
Product ID
35000-979_4d04c04b-898f-4f97-9533-a8cf8c9089cf
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Colgate-Palmolive Company
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-10-14
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
2 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35000-97935000-979-76DDiscontinued by firm2026-11-13

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-979-32COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN1 in 1 CARTONPASTE, DENTIFRICE15
35000-979-32COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN127 g in 1 TUBEPASTE, DENTIFRICE1275
35000-979-76COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN90 g in 1 TUBEPASTE, DENTIFRICE905
35000-979-76COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN2 in 1 CARTONPASTE, DENTIFRICE25
35000-979-78COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN70.8 g in 1 TUBEPASTE, DENTIFRICE70.85
35000-979-78COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN1 in 1 CARTONPASTE, DENTIFRICE15
35000-979-86COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN90 g in 1 TUBEPASTE, DENTIFRICE905
35000-979-86COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN1 in 1 CARTONPASTE, DENTIFRICE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-979COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]3Legacy NDC, 8 package rows20250227_ed20cf9d-6162-4337-bb0b-1a6a6e9e1dc3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE ADVANCED VIBRANT CLEANSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyed20cf9d-6162-4337-bb0b-1a6a6e9e1dc32025-10-21WarningsExact identifier
ndc (package): 35000-979-76
ndc (product): 35000-979
ndc11 (package): 35000097976

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038995sodium monofluorophosphate 1.14 % ToothpastePSNed20cf9d-6162-4337-bb0b-1a6a6e9e1dc35
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCDed20cf9d-6162-4337-bb0b-1a6a6e9e1dc35
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSYed20cf9d-6162-4337-bb0b-1a6a6e9e1dc35
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSYed20cf9d-6162-4337-bb0b-1a6a6e9e1dc35
1038995sodium monofluorophosphate 1.14 % ToothpasteSYed20cf9d-6162-4337-bb0b-1a6a6e9e1dc35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-979-76350000979762 TUBE in 1 CARTON (35000-979-76) > 90 g in 1 TUBE2 tube2019-10-140000-00-00NoNoCurrent