Amerfresh

Manufacturer: Amercare Products Inc
Effective date: 2011-03-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:27:36

Label at a glance#

ProductAmerfresh

Active ingredientSodium Monofluorophosphate

Label structure9 sections

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 or a physician. Children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing. Children under 2 years Ask a dentist or physician.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

FLUORIDE TOOTHPASTE

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against 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 centre immediately.

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 or a physician.
Children 2 to 6 years	use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.
Children under 2 years	Ask a dentist or physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Calcium Carbonate, Methyl Paraben Sodium, Propyl Paraben Sodium, Flavour, Sodium Saccharin,Treated water, SCMC, Sodium Lauryl Sulfate.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 141 g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AMERFRESH^®

FLUORIDE TOOTHPASTE

NET WT. 5 oz (141g)

PRINCIPAL DISPLAY PANEL - 141 g Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	1
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51460-5000-1	2019-10-29	C162847	48780-1	960f7f55-cd70-8e05-e053-dbdaa90a074a	AMERFRESH ®
51460-5000-2	2019-10-29	C162847	48780-1	960f7f55-cd70-8e05-e053-dbdaa90a074a	AMERFRESH ®
51460-5000-3	2019-10-29	C162847	48780-1	960f7f55-cd70-8e05-e053-dbdaa90a074a	AMERFRESH ®
51460-5000-4	2019-10-29	C162847	48780-1	960f7f55-cd70-8e05-e053-dbdaa90a074a	AMERFRESH ®
51460-5000-5	2019-10-29	C162847	48780-1	960f7f55-cd70-8e05-e053-dbdaa90a074a	AMERFRESH ®
51460-5000-6	2019-10-29	C162847	48780-1	960f7f55-cd70-8e05-e053-dbdaa90a074a	AMERFRESH ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51460-5000-1	Amerfresh	141 g in 1 TUBE	PASTE, DENTIFRICE	141	1
51460-5000-2	Amerfresh	85 g in 1 TUBE	PASTE, DENTIFRICE	85	1
51460-5000-3	Amerfresh	42 g in 1 TUBE	PASTE, DENTIFRICE	42	1
51460-5000-4	Amerfresh	24 g in 1 TUBE	PASTE, DENTIFRICE	24	1
51460-5000-5	Amerfresh	17 g in 1 TUBE	PASTE, DENTIFRICE	17	1
51460-5000-6	Amerfresh	4.24 g in 1 POUCH	PASTE, DENTIFRICE	4.24	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51460-5000	AMERFRESH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERCARE PRODUCTS INC]	1	Legacy NDC, 6 package rows	20110330_939919ec-5bd8-4869-8598-b5fcc8fcc08f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium Monofluorophosphate	ACTIVE INGREDIENT	C810JCZ56Q	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	1
Calcium Carbonate	INACTIVE INGREDIENT	H0G9379FGK	1
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	1
Methylparaben Sodium	INACTIVE INGREDIENT	CR6K9C2NHK	1
Propylparaben Sodium	INACTIVE INGREDIENT	625NNB0G9N	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	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 · 12 matching rows.

Amerfresh
Sodium Monofluorophosphate
Fluoride Ion
Calcium Carbonate
Water
Sorbitol
Silicon Dioxide
Sodium Lauryl Sulfate
Carboxymethylcellulose Sodium
Saccharin Sodium
Methylparaben Sodium
Propylparaben Sodium

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51460-5000	51460-5000-1, 51460-5000-2, 51460-5000-3, 51460-5000-4, 51460-5000-5, 51460-5000-6

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 Monofluorophosphate	C810JCZ56Q	ACTIB
Calcium Carbonate	H0G9379FGK	IACT
Water	059QF0KO0R	IACT
Sorbitol	506T60A25R	IACT
Silicon Dioxide	ETJ7Z6XBU4	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 4 · 240 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sorbitol	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM, AUGMENTED / TOPICAL	15 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SPRAY / TOPICAL		7 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EFFERVESCENT / ORAL	1.5 mg		Exact identifier — unii candidate 42 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
Sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Propylparaben Sodium	PROPYLPARABEN SODIUM	625NNB0G9N	SUSPENSION / ORAL		16 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE / DENTAL		249 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Calcium Carbonate	CALCIUM CARBONATE	H0G9379FGK	SOLUTION / RESPIRATORY (INHALATION)	4.02 %w/v		Exact identifier — unii candidate 15 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / VAGINAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / RECTAL		290 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Methylparaben Sodium	METHYLPARABEN SODIUM	CR6K9C2NHK	TABLET, ORALLY DISINTEGRATING / ORAL	0.3 mg		Exact identifier — unii candidate 6 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
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED / ORAL	50 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	DROPS / ORAL	NA		Exact identifier — unii candidate 42 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
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, ORALLY DISINTEGRATING / ORAL		16 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, CHEWABLE / ORAL		3555 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
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 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	INJECTION / INTRA-ARTICULAR		25 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SYRUP / ORAL	26.5 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
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET / SUBLINGUAL	1.1 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
Calcium Carbonate	CALCIUM CARBONATE	H0G9379FGK	POWDER, DENTIFRICE / DENTAL	0.5 mg/mg		Exact identifier — unii candidate 15 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET / ORAL		233 mg	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
Calcium Carbonate	CALCIUM CARBONATE	H0G9379FGK	TABLET, DELAYED RELEASE / ORAL	8.4 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	FILM / BUCCAL		18 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE PELLETS / ORAL		99 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SUSPENSION / INTRAMUSCULAR	0.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Carboxymethylcellulose Sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE / ORAL	160 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	POWDER / VAGINAL	3 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 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
Methylparaben Sodium	METHYLPARABEN SODIUM	CR6K9C2NHK	SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION / ORAL	705 mg		Exact identifier — unii candidate 42 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
ce8b2eb8-b3cb-4c19-9308-0a5cb68fa0d2			939919ec-5bd8-4869-8598-b5fcc8fcc08f	2011-03-16	Warnings	Exact identifier spl id: ce8b2eb8-b3cb-4c19-9308-0a5cb68fa0d2 spl set id: 939919ec-5bd8-4869-8598-b5fcc8fcc08f

Reported adverse events (FAERS/openFDA)#

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