Simply White

Manufacturer: Tom's of Maine, Inc.
Effective date: 2025-11-13
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 01:15:59

Label at a glance#

ProductSimply White Clean Mint

Active ingredientSODIUM FLUORIDE

Label structure9 sections

Dosage and administration

adults and children 2 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 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

Contacts and useful links#

PhoneLabel contact(412) 390-3381

PhoneLabel contact1-800-FOR-TOMS

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 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 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

water, sorbitol, hydrated silica, xylitol, glycerin, sodium lauryl sulfate, natural flavor¹, xanthan gum, sodium hydroxide, carrageenan, titanium dioxide.

1 peppermint oil and other natural flavor

Questions?

OTC - QUESTIONS SECTION

1-800-FOR-TOMS (1-800-367-8667)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THE ORIGINAL
Tom's
OF MAINE

ADA
Accepted
American
Dental
Association ®

NATURAL • WITH FLUORIDE

SIMPLY
WHITE^®

anticavity toothpaste

CLEAN MINT

4.0 OZ (113 g)

CLINICALLY PROVEN
WHITENING

REMINERALIZES ENAMEL

PREVENTS CAVITIES

NO
ANIMAL TESTING,
ARTIFICIAL FLAVORS,
SWEETENERS OR DYES

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
416783	sodium fluoride 0.24 % Toothpaste	PSN	6
416783	sodium fluoride 0.0024 MG/MG Toothpaste	SCD	6
416783	sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste	SY	6
416783	sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	6
416783	sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	6

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	PS0053606		toms-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51009-248-40	Simply WhiteClean Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	6
51009-248-40	Simply WhiteClean Mint	113 g in 1 TUBE	PASTE, DENTIFRICE	113	6
51009-248-47	Simply WhiteClean Mint	133 g in 1 TUBE	PASTE, DENTIFRICE	133	6
51009-248-47	Simply WhiteClean Mint	1 in 1 CARTON	PASTE, DENTIFRICE	1	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	1
fluoride ion	ACTIVE MOIETY	Q80VPU408O	1
Carrageenan	INACTIVE INGREDIENT	5C69YCD2YJ	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Hydrated Silica	INACTIVE INGREDIENT	Y6O7T4G8P9	1
Menthol	INACTIVE INGREDIENT	L7T10EIP3A	1
Peppermint oil	INACTIVE INGREDIENT	AV092KU4JH	1
Sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
Xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	1
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Simply White Clean Mint
Sodium fluoride
FLUORIDE ION
SORBITOL
WATER
HYDRATED SILICA
GLYCERIN
XYLITOL
SODIUM LAURYL SULFATE
XANTHAN GUM
CARRAGEENAN
TITANIUM DIOXIDE
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51009-248	51009-248-47, 51009-248-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
SORBITOL	506T60A25R	IACT
WATER	059QF0KO0R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
GLYCERIN	PDC6A3C0OX	IACT
XYLITOL	VCQ006KQ1E	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
XANTHAN GUM	TTV12P4NEE	IACT
CARRAGEENAN	5C69YCD2YJ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SODIUM HYDROXIDE	55X04QC32I	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 8 · 471 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / DENTAL	ADJ PH		Exact identifier — unii candidate 174 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
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	EMULSION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	SHAMPOO, SUSPENSION / TOPICAL	40 %w/v		Exact identifier — unii candidate 42 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 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
Glycerin	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GRANULE, FOR SUSPENSION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Carrageenan	CARRAGEENAN	5C69YCD2YJ	POWDER / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Carrageenan	CARRAGEENAN	5C69YCD2YJ	POWDER / NASAL	NA		Exact identifier — unii candidate 10 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
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / PERINEURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	CONCENTRATE / ORAL	10 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	FILM, SOLUBLE / ORAL		11 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LOTION / TOPICAL		21 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Menthol	MENTHOL	L7T10EIP3A	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATUMOR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / TOPICAL		39 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / AURICULAR (OTIC)	0.8 %w/w		Exact identifier — unii candidate 174 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
Titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 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
Glycerin	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVESICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBCUTANEOUS	31.45 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 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
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Menthol	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	SPONGE / TOPICAL	5 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, EXTENDED RELEASE / ORAL		428 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
cddbabef-2113-4acf-82c6-c493657185dd			204a3eec-3d91-456d-bc15-51363f25e711	2025-11-13	Warnings	Exact identifier spl id: cddbabef-2113-4acf-82c6-c493657185dd spl set id: 204a3eec-3d91-456d-bc15-51363f25e711

Reported adverse events (FAERS/openFDA)#

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