FDA.reportPublic FDA data

AMERFRESH FLUORIDE gel

Manufacturer
Yangzhou SION Commodity Co.,Ltd
Effective date
2024-12-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:50

Label at a glance#

ProductAMERFRESH FLUORIDE gel
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

Sorbitol, Hydrated Silica, Water, PEG-8, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Saccharin, Glycerin, anthan Gum, Sodium Benzoate, Cetylpyridinium Chloride.    

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN3
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD3
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70766-008-012026-01-29C16284748780-149896155-a5e4-586f-e063-e6dba90add9070766-008
70766-008-022026-01-29C16284748780-149896155-a5e4-586f-e063-e6dba90add9070766-008
70766-008-032026-01-29C16284748780-149896155-a5e4-586f-e063-e6dba90add9070766-008
70766-008-042026-01-29C16284748780-149896155-a5e4-586f-e063-e6dba90add9070766-008
70766-008-052026-01-29C16284748780-149896155-a5e4-586f-e063-e6dba90add9070766-008
70766-008-062026-01-29C16284748780-149896155-a5e4-586f-e063-e6dba90add9070766-008
70766-008-072026-01-29C16284748780-149896155-a5e4-586f-e063-e6dba90add9070766-008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-008-01AMERFRESH FLUORIDE gel17 g in 1 TUBEPASTE, DENTIFRICE173
70766-008-01AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1443
70766-008-02AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1443
70766-008-02AMERFRESH FLUORIDE gel24 g in 1 TUBEPASTE, DENTIFRICE243
70766-008-03AMERFRESH FLUORIDE gel43 g in 1 TUBEPASTE, DENTIFRICE433
70766-008-03AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1443
70766-008-04AMERFRESH FLUORIDE gel78 g in 1 TUBEPASTE, DENTIFRICE783
70766-008-04AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1443
70766-008-05AMERFRESH FLUORIDE gel85 g in 1 TUBEPASTE, DENTIFRICE853
70766-008-05AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1443
70766-008-06AMERFRESH FLUORIDE gel142 g in 1 TUBEPASTE, DENTIFRICE1423
70766-008-06AMERFRESH FLUORIDE gel144 in 1 BOXPASTE, DENTIFRICE1443
70766-008-07AMERFRESH FLUORIDE gel1000 in 1 BOXPASTE, DENTIFRICE10003
70766-008-07AMERFRESH FLUORIDE gel7 g in 1 POUCHPASTE, DENTIFRICE73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-008AMERFRESH FLUORIDE GEL (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU SION COMMODITY CO.,LTD]3Legacy NDC, 14 package rows20241218_11c712ee-638f-4539-b73a-2f997f433ed4.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
70766-00870766-008-01, 70766-008-02, 70766-008-03, 70766-008-04, 70766-008-05, 70766-008-06, 70766-008-07

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
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
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
2968c5c9-9a0c-0b31-e063-6394a90a404111c712ee-638f-4539-b73a-2f997f433ed42024-12-16WarningsExact identifier
spl id: 2968c5c9-9a0c-0b31-e063-6394a90a4041
spl set id: 11c712ee-638f-4539-b73a-2f997f433ed4

Reported adverse events (FAERS/openFDA)#

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