Acclean Plus

Manufacturer: Henry Schein, Inc. | Medical Products Laboratories, Inc.
Effective date: 2018-11-03
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:26:44

Label at a glance#

ProductAcclean Plus

Active ingredientSODIUM FLUORIDE

Label structure7 sections

Dosage and administration

Adults and children six years of age and older should brush with Acclean ® Plus Home Care Gel once at bedtime (or as directed by physician or dentist). Apply a thin bead of gel to toothbrush and brush for at least one minute, making sure all tooth surfaces are covered. ADULTS: Expectorate thoroughly. Do not rinse, drink or eat for at least 30 minutes after use. CHILDREN SIX YEARS OF AGE AND OLDER: Expectorat...

Label contents#

Full prescribing information#

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Carboxymethyl Cellulose, Xylitol, Sodium Benzoate, Titanium Dioxide, Sucralose, Casein, Sodium Phosphate Monobasic, Calcium Hydroxyapetite, Silica, Sodium Phosphate Dibasic, Flavor.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 1.1%

(0.5% Fluoride Ion)

Indications

INDICATIONS & USAGE SECTION

Helps prevent dental caries and hypersensitivity.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children six years of age and older should brush with Acclean^® Plus Home Care Gel once at bedtime (or as directed by physician or dentist). Apply a thin bead of gel to toothbrush and brush for at least one minute, making sure all tooth surfaces are covered. ADULTS: Expectorate thoroughly. Do not rinse, drink or eat for at least 30 minutes after use. CHILDREN SIX YEARS OF AGE AND OLDER: Expectorate and rinse thoroughly. If recommended by your dental professional, this product can be used in place of your regular toothpaste. Read all instructions and prescribing information before using this product.

Warning

WARNINGS SECTION

DO NOT SWALLOW. To avoid ingestion, supervision is required while children are using this product. Swallowing excessive amounts of fluoride could cause dental fluorosis. KEEP OUT OF REACH OF CHILDREN AND INFANTS. This product should not be used by individuals with milk allergies.

Precautions

PRECAUTIONS SECTION

Federal (U.S.A.) Law prohibits dispensing without prescription. Store at controlled room temperature 68º - 77º F (20ºC - 25ºC).

Reorder # 112-6918
Reorder # 112-6919

Distributed by (In US Only) HENRY SCHEIN INC.
135 DURYEA ROAD
Melville, NY 11747 USA

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0404-6918-01

HENRY SCHEIN^®
ACCLEAN^® PLUS

HOME CARE GEL

HENRY SCHEIN SEAL OF EXCELLENCE^®

1.1% NEUTRAL SODIUM FLUORIDE

Contains MCH-C*
*(Micronized Calcium Hydroxyapatite & Casein)

MINT FLAVOR

Net Wt. 1.4 oz. (40g)

Rx Only

NDC 0404-6919-01

HENRY SCHEIN^®
ACCLEAN^® PLUS

HOME CARE GEL

HENRY SCHEIN SEAL OF EXCELLENCE^®

1.1% NEUTRAL SODIUM FLUORIDE

Contains MCH-C*
*(Micronized Calcium Hydroxyapatite & Casein)

BUBBLE GUM FLAVOR

Net Wt. 1.4 oz. (40g)

Rx Only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
392038	sodium fluoride 1.1 % Toothpaste	PSN	3
392038	sodium fluoride 0.011 MG/MG Toothpaste	SCD	3
392038	sodium fluoride 1.1 % (fluoride ion 0.5 % ) Toothpaste	SY	3
392038	sodium fluoride 1.1 % Dental Gel	SY	3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0404-6918-01	2020-01-31	C162847	48780-1	9d75b9d0-751f-f424-e053-dadaa90a57ce	00ba2e31-f50d-9d8a-f110-1bae22bfa3d8
0404-6919-01	2020-01-31	C162847	48780-1	9d75b9d0-751f-f424-e053-dadaa90a57ce	00ba2e31-f50d-9d8a-f110-1bae22bfa3d8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-6918-01	Acclean Plus	40 g in 1 TUBE	GEL, DENTIFRICE	40		3
0404-6919-01	Acclean Plus	40 g in 1 TUBE	GEL, DENTIFRICE	40		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-6918	ACCLEAN PLUS (SODIUM FLOURIDE) GEL, DENTIFRICE [HENRY SCHEIN, INC.]	3	Legacy NDC, 1 package rows	20181104_00ba2e31-f50d-9d8a-f110-1bae22bfa3d8.zip
0404-6919	ACCLEAN PLUS (SODIUM FLOURIDE) GEL, DENTIFRICE [HENRY SCHEIN, INC.]	3	Legacy NDC, 1 package rows	20181104_00ba2e31-f50d-9d8a-f110-1bae22bfa3d8.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	INACTIVE INGREDIENT	05JZI7B19X	1
Casein	INACTIVE INGREDIENT	48268V50D5	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
Sodium Phosphate, Dibasic	INACTIVE INGREDIENT	GR686LBA74	1
Sodium Phosphate, Monobasic	INACTIVE INGREDIENT	3980JIH2SW	1
Sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
Tribasic Calcium Phosphate	INACTIVE INGREDIENT	91D9GV0Z28	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
XYLITOL	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Acclean Plus
Sodium Flouride
SODIUM FLUORIDE
FLUORIDE ION
WATER
GLYCERIN
XYLITOL
Carboxymethylcellulose
Sodium Benzoate
Titanium Dioxide
Sucralose
Casein
Sodium Phosphate, Monobasic
Tribasic Calcium Phosphate
Silicon Dioxide
Sodium Phosphate, Dibasic

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0404-6918	0404-6918-01
0404-6919	0404-6919-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
XYLITOL	VCQ006KQ1E	IACT
Carboxymethylcellulose	05JZI7B19X	IACT
Sodium Benzoate	OJ245FE5EU	IACT
Titanium Dioxide	15FIX9V2JP	IACT
Sucralose	96K6UQ3ZD4	IACT
Casein	48268V50D5	IACT
Sodium Phosphate, Monobasic	3980JIH2SW	IACT
Tribasic Calcium Phosphate	91D9GV0Z28	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Sodium Phosphate, Dibasic	GR686LBA74	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
XYLITOL	VCQ006KQ1E	IACT
Carboxymethylcellulose	05JZI7B19X	IACT
Sodium Benzoate	OJ245FE5EU	IACT
Titanium Dioxide	15FIX9V2JP	IACT
Sucralose	96K6UQ3ZD4	IACT
Casein	48268V50D5	IACT
Sodium Phosphate, Monobasic	3980JIH2SW	IACT
Tribasic Calcium Phosphate	91D9GV0Z28	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Sodium Phosphate, Dibasic	GR686LBA74	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 5 · 274 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium Phosphate, Monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	TABLET / ORAL		2 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GEL / RECTAL		406 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Tribasic Calcium Phosphate	TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	TABLET, FILM COATED / ORAL	21.8 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM / BUCCAL		3 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Carboxymethylcellulose	CARBOXYMETHYLCELLULOSE	05JZI7B19X	DROPS / ORAL	10 mg/1ml		Exact identifier — unii candidate 8 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium Phosphate, Dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 14 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sodium Phosphate, Dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	40 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
XYLITOL	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Phosphate, Dibasic	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	INJECTION / INTRADERMAL	0.2 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	SUSPENSION / ORAL		383 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	SUSPENSION, EXTENDED RELEASE / ORAL		16 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	TABLET / SUBLINGUAL		12 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	PASTE, DENTIFRICE / DENTAL	0.4 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Phosphate, Monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / IONTOPHORESIS	14.2 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	SPRAY / NASAL		2 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Sodium Phosphate, Monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	13.2 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Sucralose	SUCRALOSE	96K6UQ3ZD4	SPRAY, METERED / NASAL		2 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 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
7f1e2803-bee8-4e4f-b9f9-df749e329b5d			00ba2e31-f50d-9d8a-f110-1bae22bfa3d8	2018-11-03	Warnings	Exact identifier spl id: 7f1e2803-bee8-4e4f-b9f9-df749e329b5d spl set id: 00ba2e31-f50d-9d8a-f110-1bae22bfa3d8

Reported adverse events (FAERS/openFDA)#

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