FDA.reportPublic FDA data

Colgate Optic White Stain Fighter with Baking Soda

Manufacturer
Colgate-Palmolive Company | Mission Hills, S.A. de C.V.
Effective date
2024-03-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:13:49

Label at a glance#

ProductColgate Optic White Stain Fighter with Baking Soda
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

adults and children 2 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 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% (0.15% 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 2 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 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Sodium Saccharin, Benzyl Alcohol, Sodium Bicarbonate.

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 - 170 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Fluoride Toothpaste

ENAMEL SAFE

Removes 95% of
Daily Surface Stains*

Clean Mint Paste
with Micro-Polishing Action

OPTIC
WHITE®

STAIN FIGHTER®
with Baking Soda

NET WT
6.0 OZ (170 g)

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN5
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD5
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY5
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY5
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65954-810-42Colgate Optic White Stain Fighter with Baking Soda1 in 1 CARTONPASTE, DENTIFRICE15
65954-810-42Colgate Optic White Stain Fighter with Baking Soda119 g in 1 TUBEPASTE, DENTIFRICE1195
65954-810-60Colgate Optic White Stain Fighter with Baking Soda1 in 1 CARTONPASTE, DENTIFRICE15
65954-810-60Colgate Optic White Stain Fighter with Baking Soda170 g in 1 TUBEPASTE, DENTIFRICE1705
65954-810-63Colgate Optic White Stain Fighter with Baking Soda1 in 1 CARTONPASTE, DENTIFRICE15
65954-810-63Colgate Optic White Stain Fighter with Baking Soda85 g in 1 TUBEPASTE, DENTIFRICE855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65954-810COLGATE OPTIC WHITE STAIN FIGHTER WITH BAKING SODA (SODIUM FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]56 package rows20240619_6196fe24-cacf-44ab-ab35-378b2138b36f.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65954-81065954-810-60, 65954-810-42, 65954-810-63

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
SODIUM LAURYL SULFATE368GB5141JIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM BICARBONATE8MDF5V39QOIACT

Source Document#

Source XML

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
823e3e3f-f6b4-4def-941e-56e2f9ed9d866196fe24-cacf-44ab-ab35-378b2138b36f2024-03-01WarningsExact identifier
spl id: 823e3e3f-f6b4-4def-941e-56e2f9ed9d86
spl set id: 6196fe24-cacf-44ab-ab35-378b2138b36f

Reported adverse events (FAERS/openFDA)#

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