FDA.reportPublic FDA data

COLGATE

Manufacturer
Colgate-Palmolive Company | Mission Hills, S.A. de C.V.
Effective date
2026-07-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-07-23 05:10:08

Label at a glance#

ProductCOLGATE Great Regular Flavor
Active ingredientSODIUM MONOFLUOROPHOSPHATE
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 Monofluorophosphate 0.76% (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 the 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

Dicalcium Phosphate Dihydrate, Water, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Tetrasodium Pyrophosphate, Sodium Saccharin.

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity
Fluoride Toothpaste

NET WT 6.0 OZ (170 g)

ADA
Accepted
American
Dental
Association ®

Cavity
Protection

Strengthens Teeth
with Active Fluoride

Great Regular Flavor

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

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-91335000-913-20, 35000-913-33, 35000-913-69, 35000-913-46, 35000-913-60, 35000-913-64, 35000-913-82, 35000-913-04, 35000-913-79, 35000-913-93, 35000-913-48, 35000-913-01, 35000-913-58, 35000-913-92, 35000-913-30, 35000-913-34, 35000-913-62

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32019-12-03full-release2026-06-01 00:39:19

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 Great Regular FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company730f40f6-6ac6-49bd-888b-c0b5818a03c82026-07-20WarningsExact identifier
ndc (package): 35000-913-60
ndc (package): 35000-913-04
ndc (package): 35000-913-30
ndc (package): 35000-913-62
ndc (package): 35000-913-79
ndc (package): 35000-913-20
ndc (package): 35000-913-01
ndc (package): 35000-913-64
ndc (package): 35000-913-58
ndc (package): 35000-913-33
ndc (package): 35000-913-48
ndc (package): 35000-913-93
ndc (package): 35000-913-82
ndc (package): 35000-913-46
ndc (package): 35000-913-69
ndc (package): 35000-913-92
ndc (package): 35000-913-34
ndc (product): 35000-913
ndc11 (package): 35000091393
ndc11 (package): 35000091364
ndc11 (package): 35000091382
ndc11 (package): 35000091358
ndc11 (package): 35000091392
ndc11 (package): 35000091369
ndc11 (package): 35000091304
ndc11 (package): 35000091330
ndc11 (package): 35000091348
ndc11 (package): 35000091346
ndc11 (package): 35000091320
ndc11 (package): 35000091334
ndc11 (package): 35000091362
ndc11 (package): 35000091360
ndc11 (package): 35000091301
ndc11 (package): 35000091333
ndc11 (package): 35000091379
spl id: 5c864eeb-a3fa-4e6a-b624-29ed3cd6d2da
spl set id: 730f40f6-6ac6-49bd-888b-c0b5818a03c8

Reported adverse events (FAERS/openFDA)#

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