FDA.reportPublic FDA data

Hello Magical Mermaid

Manufacturer
Colgate-Palmolive Company
Effective date
2025-04-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:59:14

Label at a glance#

ProductHello Magical Mermaid
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% (0.14% 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

glycerin, sorbitol, water, hydrated silica, erythritol, xylitol, xanthan gum, sodium bicarbonate, lauryl glucoside, potassium citrate, tetrasodium pyrophosphate, rebaudioside a, flavor.

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®

magical mermaid

fluoride toothpaste
kids ages 2+

orange dreamsicle
natural flavor

prevents cavities
polishes + brightens
strengthens enamel
tastes magical

not tested
on mermaids

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 % ToothpastePSN4
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD4
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY4
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY4
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY4

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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
35000-680-10Hello Magical Mermaid119 g in 1 TUBEGEL, DENTIFRICE1194

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-680HELLO MAGICAL MERMAID (SODIUM FLUORIDE) GEL, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]4Current NDC, 1 package rows20250417_bdabf74f-8d1e-0f11-159a-0025bcd0ca3e.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-68035000-680-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
ERYTHRITOLRA96B954X6IACT
XYLITOLVCQ006KQ1EIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM BICARBONATE8MDF5V39QOIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
POTASSIUM CITRATEEE90ONI6FFIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
REBAUDIOSIDE AB3FUD0528FIACT

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 Magical MermaidSODIUM FLUORIDEColgate-Palmolive Companybdabf74f-8d1e-0f11-159a-0025bcd0ca3e2025-04-15WarningsExact identifier
ndc (package): 35000-680-10
ndc (product): 35000-680
ndc11 (package): 35000068010
spl id: 7bc31336-d583-4148-9161-6591c54f1474
spl set id: bdabf74f-8d1e-0f11-159a-0025bcd0ca3e

Reported adverse events (FAERS/openFDA)#

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