FDA.reportPublic FDA data

HISMILE

Manufacturer
Accupac LLC
Effective date
2024-09-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:54:31

Label at a glance#

ProductHISMILE
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

When using this product

OTC - WHEN USING SECTION

Do not swallow

Do not use in eye area

Keep out of reach of children under 6 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Direction

DOSAGE & ADMINISTRATION SECTION

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 habtis (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 ingredients

INACTIVE INGREDIENT SECTION

Water, Sorbitol

Glycerin

Hydrated Silica

Xylitol

Sodium Phosphate

Xanthan Gum

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

1,2-Hexadediol

Cellulose Gum

Sucralose

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chupa Chup labelChupa Chup label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44038-0322HISMILE (SODIUM FLUORIDE) GEL [ACCUPAC LLC]2Unmatched20240921_22794069-382d-b71d-e063-6394a90aef6d.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44038-032244038-0322-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
1,2-HEXANEDIOLTR046Y3K1GIACT
SODIUM GLUCONATER6Q3791S76IACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ZINC LACTATE2GXR25858YIACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
SUCRALOSE96K6UQ3ZD4IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
XANTHAN GUMTTV12P4NEEIACT
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
SODIUM PHOSPHATESE337SVY37IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SORBITOL506T60A25RIACT

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
2268bc8c-aa66-0d22-e063-6294a90a607922794069-382d-b71d-e063-6394a90aef6d2024-09-18WarningsExact identifier
spl id: 2268bc8c-aa66-0d22-e063-6294a90a6079
spl set id: 22794069-382d-b71d-e063-6394a90aef6d

Reported adverse events (FAERS/openFDA)#

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