AmerFresh ® Fluoride Gel Toothpaste

Manufacturer: Amercare Products, Inc.
Effective date: 2012-11-07
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:33:48

Label at a glance#

ProductAmerFresh

Active ingredientSodium Fluoride

Label structure9 sections

Dosage and administration

do not swallow supervise children as necessary until capable of using 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 doctor. Children under 2 years of age: Consult a dentist or doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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 in the prevention of dental cavities

Warning

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN 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.

Directions

DOSAGE & ADMINISTRATION SECTION

do not swallow
supervise children as necessary until capable of using 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 doctor.
Children under 2 years of age: Consult a dentist or doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

Exclusive Distributor: AMERCARE Products Inc., Seattle., WA 98165-2226.

PRINCIPAL DISPLAY PANEL - 85g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AMERFRESH^®

FLUORIDE Gel TOOTHPASTE
NET WT. 3 oz (85g)

PRINCIPAL DISPLAY PANEL - 85g Tube Label

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
51460-1111-1	2019-11-27	C162847	48780-1	9855d018-d72d-cd31-e053-dbdaa90ab51a	AmerFresh ® Fluoride Gel Toothpaste
51460-1111-2	2019-11-27	C162847	48780-1	9855d018-d72d-cd31-e053-dbdaa90ab51a	AmerFresh ® Fluoride Gel Toothpaste
51460-1111-3	2019-11-27	C162847	48780-1	9855d018-d72d-cd31-e053-dbdaa90ab51a	AmerFresh ® Fluoride Gel Toothpaste
51460-1111-4	2019-11-27	C162847	48780-1	9855d018-d72d-cd31-e053-dbdaa90ab51a	AmerFresh ® Fluoride Gel Toothpaste
51460-1111-5	2019-11-27	C162847	48780-1	9855d018-d72d-cd31-e053-dbdaa90ab51a	AmerFresh ® Fluoride Gel Toothpaste
51460-1111-6	2019-11-27	C162847	48780-1	9855d018-d72d-cd31-e053-dbdaa90ab51a	AmerFresh ® Fluoride Gel Toothpaste
51460-1111-7	2019-11-27	C162847	48780-1	9855d018-d72d-cd31-e053-dbdaa90ab51a	AmerFresh ® Fluoride Gel Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51460-1111-1	AmerFresh	85 g in 1 TUBE	GEL, DENTIFRICE	85	1
51460-1111-2	AmerFresh	7.1 g in 1 PACKET	GEL, DENTIFRICE	7.1	1
51460-1111-3	AmerFresh	17 g in 1 TUBE	GEL, DENTIFRICE	17	1
51460-1111-4	AmerFresh	24 g in 1 TUBE	GEL, DENTIFRICE	24	1
51460-1111-5	AmerFresh	43 g in 1 TUBE	GEL, DENTIFRICE	43	1
51460-1111-6	AmerFresh	130 g in 1 TUBE	GEL, DENTIFRICE	130	1
51460-1111-7	AmerFresh	181 g in 1 TUBE	GEL, DENTIFRICE	181	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51460-1111	AMERFRESH (SODIUM FLUORIDE) GEL, DENTIFRICE [AMERCARE PRODUCTS, INC.]	1	Legacy NDC, 7 package rows	20121127_7d12eab2-ad71-4743-9c47-2f3b3bc2aa81.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	1
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	1
Hydrated Silica	INACTIVE INGREDIENT	Y6O7T4G8P9	1
Methylparaben Sodium	INACTIVE INGREDIENT	CR6K9C2NHK	1
Propylparaben Sodium	INACTIVE INGREDIENT	625NNB0G9N	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

AmerFresh
Sodium Fluoride
Fluoride Ion
Sorbitol
Water
Hydrated Silica
Sodium Lauryl Sulfate
Carboxymethylcellulose Sodium
Saccharin Sodium
Methylparaben Sodium
Propylparaben Sodium

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51460-1111	51460-1111-1, 51460-1111-2, 51460-1111-3, 51460-1111-4, 51460-1111-5, 51460-1111-6, 51460-1111-7

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
Sodium Fluoride	8ZYQ1474W7	ACTIB
Sorbitol	506T60A25R	IACT
Water	059QF0KO0R	IACT
Hydrated Silica	Y6O7T4G8P9	IACT
Sodium Lauryl Sulfate	368GB5141J	IACT
Carboxymethylcellulose Sodium	K679OBS311	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
Methylparaben Sodium	CR6K9C2NHK	IACT
Propylparaben Sodium	625NNB0G9N	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 176 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sorbitol	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Propylparaben Sodium	PROPYLPARABEN SODIUM	625NNB0G9N	SOLUTION / ORAL		30 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION / INTRA-ARTICULAR		25 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Propylparaben Sodium	PROPYLPARABEN SODIUM	625NNB0G9N	TABLET, ORALLY DISINTEGRATING / ORAL	0.1 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FOR SUSPENSION / ORAL		264 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SUSPENSION / ORAL		560 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GEL / DENTAL	0.4 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, COATED / ORAL		123 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CAPSULE / ORAL		1111 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / SOFT TISSUE		15 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE / DENTAL	1.5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / SUBLINGUAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	GRANULE / ORAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SUSPENSION / RECTAL	46.18 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, CHEWABLE / ORAL	24.75 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SPRAY / TOPICAL		7 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		25 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LIQUID / ORAL		53460 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
Methylparaben Sodium	METHYLPARABEN SODIUM	CR6K9C2NHK	CAPSULE / ORAL		2 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM / BUCCAL		18 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRAMUSCULAR		30 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO / TOPICAL	65 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION/ DROPS / OPHTHALMIC		2 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Propylparaben Sodium	PROPYLPARABEN SODIUM	625NNB0G9N	SUSPENSION / ORAL		16 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / INTRALESIONAL		15 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SUSPENSION / ORAL		45000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM, SOLUBLE / BUCCAL		47 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SYSTEM / TOPICAL		1680 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	FILM, SOLUBLE / BUCCAL		2 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	LOTION / TOPICAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, DELAYED RELEASE / ORAL	4.2 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	POWDER, FOR SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ENTERAL		2920 mg	Exact identifier — unii candidate 44 equally ranked IID candidates

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
f4796a85-7502-4122-92d5-4c8af32d3273			7d12eab2-ad71-4743-9c47-2f3b3bc2aa81	2012-11-07	Warnings	Exact identifier spl id: f4796a85-7502-4122-92d5-4c8af32d3273 spl set id: 7d12eab2-ad71-4743-9c47-2f3b3bc2aa81

Reported adverse events (FAERS/openFDA)#

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