Hello Unicorn Sparkle

Manufacturer
Colgate-Palmolive Company
Effective date
2025-05-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:00:59

Label at a glance#

ProductHello Unicorn Sparkle
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

sorbitol, purified water, hydrated silica, glycerin, xylitol, xanthan gum, flavor, cocamidopropyl betaine, sodium cocoyl glutamate, stevia rebaudiana leaf extract, mica and titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

855-HI-HELLO (1-855-444-3556)

SPL UNCLASSIFIED SECTION

Dist. by Colgate-Palmolive Co.
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

choose
friendly®
hello®

unicorn sparkle
fluoride toothpaste
kids ages 2+

bubble gum
natural flavor

prevents cavities
polishes + brightens
strengthens enamel
tastes magical

not tested
on unicorns

no artificial sweeteners. no dyes.
no SLS. no brainer.

NET WT 4.2 OZ (119 g)

Principal Display Panel - 119 g Tube Carton
Principal Display Panel - 119 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-686-10Hello Unicorn Sparkle1 in 1 CARTONGEL, DENTIFRICE13
35000-686-10Hello Unicorn Sparkle119 g in 1 TUBEGEL, DENTIFRICE1193

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-686HELLO UNICORN SPARKLE (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]3Current NDC, 2 package rows20250515_5acfbd9b-278c-24dd-8041-5e2cdffbf710.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-68635000-686-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hello Unicorn SparkleSODIUM FLUORIDEColgate-Palmolive Company5acfbd9b-278c-24dd-8041-5e2cdffbf7102025-05-13WarningsExact identifier
ndc (package): 35000-686-10
ndc (product): 35000-686
ndc11 (package): 35000068610
spl id: f02aba21-2ca9-4896-80b2-031b0430ecf4
spl set id: 5acfbd9b-278c-24dd-8041-5e2cdffbf710

Reported adverse events (FAERS/openFDA)#

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