AMERFRESH

Manufacturer: SUHAN AEROSOL
Effective date: 2020-12-03
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:34:04

Label at a glance#

ProductAMERFRESH

Active ingredientSODIUM FLUORIDE

Label structure7 sections

Indications and uses

aids in the prevention of dental cavities

Dosage and administration

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. Do not swallow. To minimize the swallowing ,use a pea-sized amount in children under 6 years old. Supervise children’s brushing until good habits are established. Children under 2 yrs : ask a dentist before use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride-0.22%

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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.
Do not swallow.
To minimize the swallowing ,use a pea-sized amount in children under 6 years old.
Supervise children’s brushing until good habits are established.
Children under 2 yrs : ask a dentist before use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Water,Sorbitol,Hydrated Silica, Sodium Lauryl Sulphate,Sodium Carboxymethyl cellulose, Flavor, Sodium Saccharin, Sodium methyl paraben, Sodium propyl paraben.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	1
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	1
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73398-114-01	2022-01-28	C162847	48780-1	d6a99b3a-004b-a426-e053-dadaa90af4c2	AMERFRESH FLUORIDE TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73398-114-01	AMERFRESH	7.1 g in 1 POUCH	PASTE	7.1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73398-114	AMERFRESH (SODIUM FLUORIDE) PASTE [SUHAN AEROSOL]	1	Legacy NDC, 1 package rows	20201205_515d34ce-eed4-4c40-9ff9-997a08132bb5.zip

Products#

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

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

AMERFRESH
Sodium fluoride
FLUORIDE ION
CALCIUM CARBONATE
WATER
SORBITOL
HYDRATED SILICA
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
SACCHARIN SODIUM
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73398-114	73398-114-01

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
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
CALCIUM CARBONATE	H0G9379FGK	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED	K679OBS311	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
METHYLPARABEN SODIUM	CR6K9C2NHK	IACT
PROPYLPARABEN SODIUM	625NNB0G9N	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5eefe504-c833-4855-b74e-d8c1fd86f926			515d34ce-eed4-4c40-9ff9-997a08132bb5	2020-12-03	Warnings	Exact identifier spl id: 5eefe504-c833-4855-b74e-d8c1fd86f926 spl set id: 515d34ce-eed4-4c40-9ff9-997a08132bb5

Reported adverse events (FAERS/openFDA)#

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