FDA.reportPublic FDA data

Hismile

Manufacturer
Hismile Pty Ltd | Accupac LLC
Effective date
2025-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:55

Label at a glance#

ProductHismile
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Use

Aids in the prevention of dental cavities

WARNINGS SECTION

Warnings

When using this product

  • Do not swallow
  • Do not use in eye area

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.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor.

Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Flavor

Sodium Methyl Cocoyl Taurate

Xanthan Gum

Cellulose Gum

Sodium Lauroyl Sarcosinate

Sucralose

Tetrapotassium Pyrophosphate

Sodium Phosphate

Lauryl Glucoside

Sodium Gluconate

1,2-Hexanediol

Mica

Zinc Lactate

Methyl Diisopropyl Propionamide

Titanium Dioxide

Iron Oxides

FD&C Red No.40

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hismile Lucky Charms Magically Delicious Flavor Sodium Fluoride Anticavity Toothpaste Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelFrontLabelFront

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelBackLabelBack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83013-335-06Hismile60 g in 1 BOTTLE, PUMPGEL, DENTIFRICE601

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83013-33583013-335-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM GLUCONATER6Q3791S76IACT
SODIUM LAURYL SARCOSINATE5PGH842FAUIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ZINC LACTATE2GXR25858YIACT
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SUCRALOSE96K6UQ3ZD4IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
XYLITOLVCQ006KQ1EIACT
XANTHAN GUMTTV12P4NEEIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
IRON OXIDES1K09F3G675IACT
FD&C RED NO. 40WZB9127XOAIACT
TETRAPOTASSIUM PYROPHOSPHATEB9W4019H5GIACT
SODIUM PHOSPHATESE337SVY37IACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
MICAV8A1AW0880IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
CELLULOSE GUMK679OBS311IACT

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
HismileMAGICALLY DELICIOUS FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHismile Pty Ltd309366f8-6a52-fe9f-e063-6394a90a5de32025-03-18WarningsExact identifier
ndc (package): 83013-335-06
ndc (product): 83013-335
ndc11 (package): 83013033506
spl id: 309366f8-6a53-fe9f-e063-6394a90a5de3
spl set id: 309366f8-6a52-fe9f-e063-6394a90a5de3

Reported adverse events (FAERS/openFDA)#

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