FDA.reportPublic FDA data

Amerfresh

Manufacturer
Yangzhou SION Commodity Co.,Ltd
Effective date
2023-12-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:03:37

Label at a glance#

ProductAmerfresh
Active ingredientSODIUM MONOFLUOROPHOSPHATE
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 monofluorophosphate 0.76%(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

calcium carbonate,water,sorbitol,hydrated silica,sodium lauryl sulfate,sodium carboxymethyl cellulose,flavor,sodium sacharine,polymethylene glycol,guar gum,methylisothiazolinone.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aa

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN5
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY5
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70766-001-012026-01-29C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-022026-01-29C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-032026-01-29C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-042026-01-29C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-052026-01-29C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-062026-01-29C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-072026-01-29C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-012023-12-08C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-022023-12-08C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-032023-12-08C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-042023-12-08C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-052023-12-08C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-062023-12-08C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-072023-12-08C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-012022-01-28C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-022022-01-28C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-032022-01-28C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-042022-01-28C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-052022-01-28C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-062022-01-28C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste
70766-001-072022-01-28C16284748780-1d6a99b39-9a35-a426-e053-dadaa90af4c270766-001 Amerfresh Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-001-01Amerfresh144 in 1 BOXPASTE1445
70766-001-01Amerfresh17 g in 1 TUBEPASTE175
70766-001-02Amerfresh144 in 1 BOXPASTE1445
70766-001-02Amerfresh24 g in 1 TUBEPASTE245
70766-001-03Amerfresh43 g in 1 TUBEPASTE435
70766-001-03Amerfresh144 in 1 BOXPASTE1445
70766-001-04Amerfresh78 g in 1 TUBEPASTE785
70766-001-04Amerfresh144 in 1 BOXPASTE1445
70766-001-05Amerfresh144 in 1 BOXPASTE1445
70766-001-05Amerfresh85 g in 1 TUBEPASTE855
70766-001-06Amerfresh142 g in 1 TUBEPASTE1425
70766-001-06Amerfresh144 in 1 BOXPASTE1445
70766-001-07Amerfresh7 g in 1 BAGPASTE75
70766-001-07Amerfresh1000 in 1 BOXPASTE10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-001AMERFRESH (SODIUM FLUORIDE) PASTE [YANGZHOU SION COMMODITY CO.,LTD]5Legacy NDC, 14 package rows20231208_35df5050-2215-4b1d-e054-00144ff8d46c.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
70766-00170766-001-01, 70766-001-02, 70766-001-03, 70766-001-04, 70766-001-05, 70766-001-06, 70766-001-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAR GUME89I1637KEIACT
POTASSIUM SODIUM SACCHARATE73U34YC90UIACT
CALCIUM CARBONATEH0G9379FGKIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
METHYLENE GLYCOL6Z20YM9257IACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
DISODIUM CARBOXYMETHYLARSONATET9HTL93NB7IACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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
0bf9a782-c0dc-85bf-e063-6294a90af81535df5050-2215-4b1d-e054-00144ff8d46c2023-12-08WarningsExact identifier
spl id: 0bf9a782-c0dc-85bf-e063-6294a90af815
spl set id: 35df5050-2215-4b1d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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