FDA.reportPublic FDA data

COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN

Manufacturer
Colgate-Palmolive Company | Mission Hills, S.A. de C.V.
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:41:36

Label at a glance#

ProductCOLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Dosage and administration

adults and children 6 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 6 to 12 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 6 years do not use unless directed by a dentist or physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 1.14% (0.19% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 6 to 12 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 6 yearsdo not use unless directed by a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, PEG-12, Glycerin, Flavor, Hydrogen Peroxide, Sodium Lauryl Sulfate, Silica, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 127 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Fluoride Toothpaste

NOW 2X WHITENING INGREDIENT†

OPTIC
WHITE®
ADVANCED

DEEPLY WHITENS FOR
UP TO FOUR SHADES*

HYDROGEN
2%
PEROXIDE

ENAMEL SAFE

NET WT 4.5 OZ (127 g)

VIBRANT CLEAN

PRINCIPAL DISPLAY PANEL - 127 g Tube Carton
PRINCIPAL DISPLAY PANEL - 127 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038995sodium monofluorophosphate 1.14 % ToothpastePSN5
1038995sodium monofluorophosphate 0.0114 MG/MG ToothpasteSCD5
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.17 % )ToothpasteSY5
1038995sodium monofluorophosphate 1.14 % (fluoride ion 0.19 % )ToothpasteSY5
1038995sodium monofluorophosphate 1.14 % ToothpasteSY5

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-97935000-979-32, 35000-979-86, 35000-979-76, 35000-979-78

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
PROPYLENE GLYCOL6DC9Q167V3IACT
CALCIUM PYROPHOSPHATEX69NU20D19IACT
POVIDONE K15E54VE15114IACT
PEG/PPG-116/66 COPOLYMERJP0CK963E0IACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDIACT
SUCRALOSE96K6UQ3ZD4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32019-10-10full-release2026-06-01 00:56:06

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): 35000-979-32
ndc (package): 35000-979-76
ndc (package): 35000-979-86
ndc (package): 35000-979-78
ndc (product): 35000-979
ndc11 (package): 35000097976
ndc11 (package): 35000097986
ndc11 (package): 35000097978
ndc11 (package): 35000097932
spl id: 4953d031-17cb-47e3-9d35-2358e62927ee
spl set id: ed20cf9d-6162-4337-bb0b-1a6a6e9e1dc3

Reported adverse events (FAERS/openFDA)#

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