FDA.reportPublic FDA data

AMERFRESH FLUORIDE

Manufacturer
Yangzhou ONE & ONLY Personal Care Products Co., LTD
Effective date
2025-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:52:54

Label at a glance#

ProductAMERFRESH FLUORIDE
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Indications and uses

Aids in the prevention of dental cavities.

Dosage and administration

do not swallow supervise children as necessary until capable of useing without supervision instruct children under 12 years of age in good brushing and rinsing habits(to minimize swallowing). Adults and children 6 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 a physician. Children under 6 years of age:do not use unless directed by a ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.22%(0.1 w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

anticavity toothpaste

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not swallow
  • supervise children as necessary until capable of useing without supervision
  • instruct children under 12 years of age in good brushing and rinsing habits(to minimize swallowing).
  • Adults and children 6 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 a physician.
  • Children under 6 years of age:do not use unless directed by a doctor or dentist.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Sorbitol, Hydrated Silica, Water, PEG-8, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Hydroypropyl Guar, Sodium Saccharin, Methylparaben, Propylparaben 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN1
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD1
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85162-002-01AMERFRESH FLUORIDE17 g in 1 TUBEPASTE, DENTIFRICE171
85162-002-01AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-02AMERFRESH FLUORIDE24 g in 1 TUBEPASTE, DENTIFRICE241
85162-002-02AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-03AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-03AMERFRESH FLUORIDE43 g in 1 TUBEPASTE, DENTIFRICE431
85162-002-04AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-04AMERFRESH FLUORIDE78 g in 1 TUBEPASTE, DENTIFRICE781
85162-002-05AMERFRESH FLUORIDE85 g in 1 TUBEPASTE, DENTIFRICE851
85162-002-05AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-06AMERFRESH FLUORIDE142 g in 1 TUBEPASTE, DENTIFRICE1421
85162-002-06AMERFRESH FLUORIDE144 in 1 BOXPASTE, DENTIFRICE1441
85162-002-07AMERFRESH FLUORIDE7 g in 1 POUCHPASTE, DENTIFRICE71
85162-002-07AMERFRESH FLUORIDE1000 in 1 BOXPASTE, DENTIFRICE10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85162-002AMERFRESH FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU ONE & ONLY PERSONAL CARE PRODUCTS CO., LTD]1Current NDC, 14 package rows20250117_827e45bb-84c0-48ee-a60b-2cc32b8f33e3.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85162-00285162-002-01, 85162-002-02, 85162-002-03, 85162-002-04, 85162-002-05, 85162-002-06, 85162-002-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
SODIUM CARBONATE45P3261C7TIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%)3A1I7376TCIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
AMERFRESH FLUORIDESODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD827e45bb-84c0-48ee-a60b-2cc32b8f33e32025-01-16WarningsExact identifier
ndc (package): 85162-002-06
ndc (package): 85162-002-01
ndc (package): 85162-002-05
ndc (package): 85162-002-07
ndc (package): 85162-002-03
ndc (package): 85162-002-04
ndc (package): 85162-002-02
ndc (product): 85162-002
ndc11 (package): 85162000203
ndc11 (package): 85162000201
ndc11 (package): 85162000205
ndc11 (package): 85162000207
ndc11 (package): 85162000204
ndc11 (package): 85162000206
ndc11 (package): 85162000202
spl id: 2bce0fcd-1d50-cf52-e063-6394a90a3603
spl set id: 827e45bb-84c0-48ee-a60b-2cc32b8f33e3

Reported adverse events (FAERS/openFDA)#

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