FDA.reportPublic FDA data

Amerfresh

Manufacturer
Yangzhou SION Commodity Co.,Ltd
Effective date
2023-12-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:03:37

Label at a glance#

ProductAmerfresh
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 ...

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

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,polyethylene glycol,sodium carboxymethyl cellulose ,xanthan gum,hydrated silica,glycerin,sacchairn sodium,sodium lauryl sulfate,water,methylisothiazolinone

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN10
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD10
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY10

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70766-002-012023-12-08C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-022023-12-08C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-032023-12-08C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-042023-12-08C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-052023-12-08C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-062023-12-08C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-072023-12-08C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-082023-12-08C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-092023-12-08C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-102023-12-08C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-112023-12-08C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-122023-12-08C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-012023-01-30C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-022023-01-30C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-032023-01-30C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-042023-01-30C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-052023-01-30C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-062023-01-30C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-072023-01-30C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-082023-01-30C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-092023-01-30C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-102023-01-30C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-112023-01-30C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste
70766-002-122023-01-30C16284748780-1f386c649-f7d8-0266-e053-dadaa90a7c1aAmerfresh Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-002-01Amerfresh17 g in 1 TUBEPASTE1710
70766-002-01Amerfresh144 in 1 BOXPASTE14410
70766-002-02Amerfresh24 g in 1 TUBEPASTE2410
70766-002-02Amerfresh144 in 1 BOXPASTE14410
70766-002-03Amerfresh43 g in 1 TUBEPASTE4310
70766-002-03Amerfresh144 in 1 BOXPASTE14410
70766-002-04Amerfresh144 in 1 BOXPASTE14410
70766-002-04Amerfresh78 g in 1 TUBEPASTE7810
70766-002-05Amerfresh85 g in 1 TUBEPASTE8510
70766-002-05Amerfresh144 in 1 BOXPASTE14410
70766-002-06Amerfresh142 g in 1 TUBEPASTE14210
70766-002-06Amerfresh144 in 1 BOXPASTE14410
70766-002-07Amerfresh1000 in 1 BOXPASTE100010
70766-002-07Amerfresh7 g in 1 BAGPASTE710
70766-002-08Amerfresh144 in 1 BOXPASTE14410
70766-002-08Amerfresh5 in 1 CARTONPASTE510
70766-002-09Amerfresh5 in 1 CARTONPASTE510
70766-002-09Amerfresh144 in 1 BOXPASTE14410
70766-002-10Amerfresh1000 in 1 BOXPASTE100010
70766-002-10Amerfresh7.1 g in 1 BAGPASTE7.110
70766-002-11Amerfresh142 g in 1 TUBEPASTE14210
70766-002-11Amerfresh72 in 1 BOXPASTE7210
70766-002-12Amerfresh181 g in 1 TUBEPASTE18110
70766-002-12Amerfresh72 in 1 BOXPASTE7210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-002AMERFRESH (SODIUM FLUORIDE) PASTE [YANGZHOU SION COMMODITY CO.,LTD]10Legacy NDC, 24 package rows20231208_3f735eed-d9e6-2720-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70766-00270766-002-01, 70766-002-02, 70766-002-03, 70766-002-04, 70766-002-05, 70766-002-06, 70766-002-07, 70766-002-10, 70766-002-08, 70766-002-09, 70766-002-11, 70766-002-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
DISODIUM CARBOXYMETHYLARSONATET9HTL93NB7IACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
METHYLENE GLYCOL6Z20YM9257IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
HYDRATED SILICAY6O7T4G8P9IACT
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
0bf9dc10-06e0-0ebc-e063-6294a90a734a3f735eed-d9e6-2720-e054-00144ff88e882023-12-08WarningsExact identifier
spl id: 0bf9dc10-06e0-0ebc-e063-6294a90a734a
spl set id: 3f735eed-d9e6-2720-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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