FDA.reportPublic FDA data

Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast

Manufacturer
HISMILE PTY LTD | Nutrix International, LLC.
Effective date
2025-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:41:18

Label at a glance#

ProductBlue Raspberry Flavor Sodium Fluoride Anticavity Toothpast
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Indications and uses

Aids in the prevention of dental cavities.

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 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.

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

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

Warnings

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

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.

Directions

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 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 ingredients

INACTIVE INGREDIENT SECTION

Water

Glycerin

Hydrated Silica

Xylitol

Sorbitol

Cellulose Gum

Flavor

1,2-Hexanediol

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

Sucralose

Caprylyl Glycol

Sodium Phosphate

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

Blue 1

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN1
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD1
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83013-341-10Blue Raspberry Flavor Sodium Fluoride Anticavity Toothpast100 g in 1 TUBEGEL1001

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83013-34183013-341-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
ZINC LACTATE2GXR25858YIACT
XYLITOLVCQ006KQ1EIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
HYDRATED SILICAY6O7T4G8P9IACT
CAPRYLYL GLYCOL00YIU5438UIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
SUCRALOSE96K6UQ3ZD4IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
TETRAPOTASSIUM PYROPHOSPHATEB9W4019H5GIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
SODIUM GLUCONATER6Q3791S76IACT
BLUE 1H3R47K3TBDIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

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
Blue Raspberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD42583b32-525f-925d-e063-6294a90af76f2025-10-29WarningsExact identifier
ndc (package): 83013-341-10
ndc (product): 83013-341
ndc11 (package): 83013034110
spl id: 42583b32-5260-925d-e063-6294a90af76f
spl set id: 42583b32-525f-925d-e063-6294a90af76f

Reported adverse events (FAERS/openFDA)#

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