Amerfresh Fluoride

Manufacturer: Amercare Products, Inc.
Effective date: 2016-10-18
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:47:40

Label at a glance#

ProductAmerfresh Fluoride

Active ingredientSODIUM FLUORIDE

Label structure6 sections

Dosage and administration

Adults and children 2 yrs. and older: Brush teeth thoroughly after meals or at least twice a day or as directed by a dentist. Do not swallow To minimize 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 Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

aids prevention of dental cavities

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 yrs. of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 yrs. and older: Brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.
Do not swallow
To minimize 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

sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharine, sodium methyl paraben, sodium propyl paraben.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelDrugFacts

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	2
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	2
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51460-3030-1	2020-01-31	C162847	48780-1	9d75b9d0-e593-f424-e053-dadaa90a57ce	Amerfresh Fluoride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51460-3030-1	Amerfresh Fluoride	7.1 g in 1 PACKET	PASTE	7.1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51460-3030	AMERFRESH FLUORIDE (SODIUM FLUORIDE) PASTE [AMERCARE PRODUCTS, INC.]	2	Legacy NDC, 1 package rows	20161019_3f2912cd-3bfe-7048-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Amerfresh Fluoride
SODIUM FLUORIDE
SORBITOL
WATER
HYDRATED SILICA
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
SACCHARIN SODIUM
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51460-3030	51460-3030-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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

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
3f28a4c7-a6b8-363d-e054-00144ff8d46c			3f2912cd-3bfe-7048-e054-00144ff88e88	2016-10-18	Warnings	Exact identifier spl id: 3f28a4c7-a6b8-363d-e054-00144ff8d46c spl set id: 3f2912cd-3bfe-7048-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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