Tom's OF MAINE WHOLE CARE fluoride toothpaste gel

Manufacturer: Tom's of Maine, Inc.
Effective date: 2022-12-19
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 21:43:49

Label at a glance#

ProductWhole Care Orange Mango

Active ingredientSODIUM FLUORIDE

Label structure11 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

sorbitol, hydrated silica, water, glycerin, Citrus aurantium dulcis (orange) peel oil and other natural flavors, xylitol, sodium lauryl sulfate, zinc citrate, xanthan gum.

Questions?

OTC - QUESTIONS SECTION

1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5:30 p.m. ET

PRINCIPAL DISPLAY PANEL - 133 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Since 1970
Tom's
OF MAINE™

with fluoride | natural

WHOLE CARE^®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

orange mango gel

NET WT 4.7 OZ (133 g)

PRINCIPAL DISPLAY PANEL - 133 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Since 1970
Tom's
OF MAINE™

with fluoride | natural

WHOLE CARE^®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

peppermint gel

NET WT 4.7 OZ (133 g)

PRINCIPAL DISPLAY PANEL - 133 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Since 1970
Tom's
OF MAINE™

with fluoride | natural

WHOLE CARE^®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

spearmint gel

NET WT 4.7 OZ (133 g)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51009-119-47	2022-12-19	C162847	48780-1	ba0f9c33-283f-a910-e053-dadaa90a0b85	Tom's OF MAINE WHOLE CARE fluoride toothpaste gel
51009-158-47	2022-12-19	C162847	48780-1	ba0f9c33-283f-a910-e053-dadaa90a0b85	Tom's OF MAINE WHOLE CARE fluoride toothpaste gel
51009-119-47	2021-01-29	C162847	48780-1	ba0f9c33-283f-a910-e053-dadaa90a0b85	Tom's OF MAINE WHOLE CARE fluoride toothpaste gel
51009-158-47	2021-01-29	C162847	48780-1	ba0f9c33-283f-a910-e053-dadaa90a0b85	Tom's OF MAINE WHOLE CARE fluoride toothpaste gel

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	2
Fluoride ion	ACTIVE MOIETY	Q80VPU408O	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Hydrated Silica	INACTIVE INGREDIENT	Y6O7T4G8P9	2
Mango	INACTIVE INGREDIENT	I629I3NR86	2
Orange Oil	INACTIVE INGREDIENT	AKN3KSD11B	2
Peppermint oil	INACTIVE INGREDIENT	AV092KU4JH	2
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	2
Sorbitol	INACTIVE INGREDIENT	506T60A25R	2
Spearmint Oil	INACTIVE INGREDIENT	C3M81465G5	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2
Xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	2
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	2
Zinc citrate	INACTIVE INGREDIENT	K72I3DEX9B	2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Whole Care Orange Mango
Sodium fluoride
FLUORIDE ION
SORBITOL
HYDRATED SILICA
GLYCERIN
WATER
XYLITOL
SODIUM LAURYL SULFATE
ZINC CITRATE
XANTHAN GUM
MANGO
ORANGE OIL, COLD PRESSED
Whole Care Spearmint
SPEARMINT OIL
PEPPERMINT OIL
Whole Care Peppermint

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51009-119	51009-119-47
51009-153	51009-153-47
51009-158	51009-158-47

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
XYLITOL	VCQ006KQ1E	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
ZINC CITRATE	K72I3DEX9B	IACT
XANTHAN GUM	TTV12P4NEE	IACT
MANGO	I629I3NR86	IACT
ORANGE OIL, COLD PRESSED	AKN3KSD11B	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
XYLITOL	VCQ006KQ1E	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
ZINC CITRATE	K72I3DEX9B	IACT
XANTHAN GUM	TTV12P4NEE	IACT
SPEARMINT OIL	C3M81465G5	IACT
PEPPERMINT OIL	AV092KU4JH	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
SORBITOL	506T60A25R	IACT
HYDRATED SILICA	Y6O7T4G8P9	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
XYLITOL	VCQ006KQ1E	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
ZINC CITRATE	K72I3DEX9B	IACT
XANTHAN GUM	TTV12P4NEE	IACT
PEPPERMINT OIL	AV092KU4JH	IACT

Source Document#

Source XML · Source PDF

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 · 236 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Spearmint Oil	SPEARMINT OIL	C3M81465G5	PASTE, DENTIFRICE / DENTAL	27.6 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SYSTEM / TOPICAL		6300 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 12 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
Xylitol	XYLITOL	VCQ006KQ1E	SOLUTION / ORAL		21600 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	AEROSOL, FOAM / TOPICAL	4.95 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	ELIXIR / ORAL	0.04 mg/1ml		Exact identifier — unii candidate 21 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION, CONCENTRATE / ORAL	300 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Orange Oil	ORANGE OIL, COLD PRESSED	AKN3KSD11B	TABLET / SUBLINGUAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Spearmint Oil	SPEARMINT OIL	C3M81465G5	SUSPENSION / ORAL	0.59 mg/20ml		Exact identifier — unii candidate 7 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET, EXTENDED RELEASE / ORAL		2752 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		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 lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 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
Xylitol	XYLITOL	VCQ006KQ1E	SPRAY / SUBLINGUAL		22 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	GUM, CHEWING / BUCCAL		11915 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 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	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Spearmint Oil	SPEARMINT OIL	C3M81465G5	CAPSULE / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET / ORAL	15.04 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING / ORAL	0.15 mg		Exact identifier — unii candidate 29 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
Xanthan gum	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Orange Oil	ORANGE OIL, COLD PRESSED	AKN3KSD11B	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Peppermint oil	PEPPERMINT OIL	AV092KU4JH	PASTE, DENTIFRICE / DENTAL	49.3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED PELLETS / ORAL		1 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Xanthan gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 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
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 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
Glycerin	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 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
46253b87-1ebd-4fb3-a947-a3329a82b3c7			76c9ac4b-207a-41e6-b8bb-f292e9a36873	2023-01-13	Warnings	Exact identifier spl set id: 76c9ac4b-207a-41e6-b8bb-f292e9a36873

Reported adverse events (FAERS/openFDA)#

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