Colgate Great Regular Flavor

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2024-10-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:40

Label at a glance#

ProductColgate Great Regular Flavor
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 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 or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-468-6502

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ColgateColgate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-118-01Colgate Great Regular Flavor1 in 1 BLISTER PACKPASTE, DENTIFRICE12
67751-118-01Colgate Great Regular Flavor24 g in 1 TUBEPASTE, DENTIFRICE242
67751-118-02Colgate Great Regular Flavor24 g in 1 TUBEPASTE, DENTIFRICE242
67751-118-02Colgate Great Regular Flavor1 in 1 BLISTER PACKPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-118COLGATE GREAT REGULAR FLAVOR (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [NAVAJO MANUFACTURING COMPANY INC.]2Current NDC, 4 package rows20241004_f89bf259-b738-8229-e053-6394a90a0c59.zip

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
67751-11867751-118-01, 67751-118-02
35000-913

Ingredients#

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

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

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 · 2 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 (product): 35000-913
Colgate Great Regular FlavorSODIUM MONOFLUOROPHOSPHATENavajo Manufacturing Company Inc.f89bf259-b738-8229-e053-6394a90a0c592024-10-03WarningsExact identifier
ndc (package): 67751-118-02
ndc (package): 67751-118-01
ndc (product): 67751-118
ndc11 (package): 67751011801
ndc11 (package): 67751011802
spl id: 239658a4-9692-0ca2-e063-6394a90a3baa
spl set id: f89bf259-b738-8229-e053-6394a90a0c59

Reported adverse events (FAERS/openFDA)#

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