Whole Care

Manufacturer
Tom's of Maine, Inc.
Effective date
2011-02-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:17

Label at a glance#

ProductWhole Care Cinnamon Clove
Active ingredientSodium monofluorophosphate
Label structure12 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.13% 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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, water, calcium carbonate, hydrated silica, xylitol, Chondrus crispus (carrageenan), sodium lauryl sulfate, sodium bicarbonate, zinc citrate, Cinnamomum cassia (cinnamon) leaf oil and other natural flavors.

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

cinnamon clove

NET WT 4.7 OZ (133 g)

Principal Display Panel - 133 g Carton
Principal Display Panel - 133 g Carton

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

NET WT 4.7 OZ (133 g)

Principal Display Panel - 133 g Carton
Principal Display Panel - 133 g Carton

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

NET WT 4.7 OZ (133 g)

Principal Display Panel - 133 g Carton
Principal Display Panel - 133 g Carton

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

wintermint

NET WT 4.7 OZ (133 g)

Principal Display Panel - 133 g Carton
Principal Display Panel - 133 g Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51009-100-47Whole Care Cinnamon Clove1 in 1 CARTONPASTE, DENTIFRICE11
51009-100-47Whole Care Cinnamon Clove133 g in 1 TUBEPASTE, DENTIFRICE1331
51009-104-47Whole Care Peppermint133 g in 1 TUBEPASTE, DENTIFRICE1331
51009-104-47Whole Care Peppermint1 in 1 CARTONPASTE, DENTIFRICE11
51009-105-47Whole Care Spearmint1 in 1 CARTONPASTE, DENTIFRICE11
51009-105-47Whole Care Spearmint133 g in 1 TUBEPASTE, DENTIFRICE1331
51009-106-47Whole Care Wintermint1 in 1 CARTONPASTE, DENTIFRICE11
51009-106-47Whole Care Wintermint133 g in 1 TUBEPASTE, DENTIFRICE1331

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-100WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1Legacy NDC, 2 package rows20110222_7f20f8a0-75f9-4365-b00a-a53c6a35b448.zip
51009-104WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1Legacy NDC, 2 package rows20110222_7f20f8a0-75f9-4365-b00a-a53c6a35b448.zip
51009-105WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1Legacy NDC, 2 package rows20110222_7f20f8a0-75f9-4365-b00a-a53c6a35b448.zip
51009-106WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE WHOLE CARE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [TOM'S OF MAINE, INC.]1Legacy NDC, 2 package rows20110222_7f20f8a0-75f9-4365-b00a-a53c6a35b448.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium monofluorophosphateACTIVE INGREDIENTC810JCZ56Q1
fluoride ionACTIVE MOIETYQ80VPU408O1
Calcium carbonateINACTIVE INGREDIENTH0G9379FGK1
CarrageenanINACTIVE INGREDIENT5C69YCD2YJ1
Cinnamon leaf oilINACTIVE INGREDIENTS92U8SQ71V1
Clove oilINACTIVE INGREDIENT578389D6D01
Clove stem oilINACTIVE INGREDIENT9368YZM9M41
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P91
Methyl salicylateINACTIVE INGREDIENTLAV5U5022Y1
Peppermint OilINACTIVE INGREDIENTAV092KU4JH1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141J1
Spearmint OilINACTIVE INGREDIENTC3M81465G51
WaterINACTIVE INGREDIENT059QF0KO0R1
XylitolINACTIVE INGREDIENTVCQ006KQ1E1
Zinc citrateINACTIVE INGREDIENTK72I3DEX9B1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

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 · 193 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
42 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii candidate
12 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii candidate
42 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JSUSPENSION, EXTENDED RELEASE / ORAL0.08 mg/1mlExact identifier — unii candidate
42 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii candidate
15 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHSOLUTION / DENTAL0.04 %v/vExact identifier — unii candidate
21 equally ranked IID candidates
Spearmint OilSPEARMINT OILC3M81465G5CAPSULE / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii candidate
12 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHSPRAY, METERED / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0SUSPENSION / ORAL0.1 mg/5mlExact identifier — unii candidate
3 equally ranked IID candidates
Calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, DELAYED RELEASE / ORAL8.4 mgExact identifier — unii candidate
15 equally ranked IID candidates
Clove oilCLOVE OIL578389D6D0ELIXIR / ORAL0.42 mg/5mlExact identifier — unii candidate
3 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHTABLET / SUBLINGUAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ETABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHCONCENTRATE / ORAL0.05 mgExact identifier — unii candidate
21 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHSUSPENSION / ORAL100 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii candidate
12 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii candidate
21 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE, DELAYED RELEASE PELLETS / ORAL99 mgExact identifier — unii candidate
42 equally ranked IID candidates
Spearmint OilSPEARMINT OILC3M81465G5SOLUTION / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii candidate
12 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
Calcium carbonateCALCIUM CARBONATEH0G9379FGKTABLET, FILM COATED / ORAL300 mgExact identifier — unii candidate
15 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XylitolXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii candidate
12 equally ranked IID candidates
CarrageenanCARRAGEENAN5C69YCD2YJPASTE / DENTAL0.3 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
42 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JPOWDER / VAGINAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
Peppermint OilPEPPERMINT OILAV092KU4JHSOLUTION / ORAL53 mgExact identifier — unii candidate
21 equally ranked IID candidates
Spearmint OilSPEARMINT OILC3M81465G5TABLET / SUBLINGUAL0.4 mgExact identifier — unii candidate
7 equally ranked IID candidates
Methyl salicylateMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
8 equally ranked IID candidates
Methyl salicylateMETHYL SALICYLATELAV5U5022YCAPSULE / ORAL16 mgExact identifier — unii candidate
8 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JCREAM / TOPICAL214 mgExact identifier — unii candidate
42 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JDROPS / ORALNAExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3452f64a-225d-428c-95d3-df5bd9c8d8267f20f8a0-75f9-4365-b00a-a53c6a35b4482011-02-11WarningsExact identifier
spl id: 3452f64a-225d-428c-95d3-df5bd9c8d826
spl set id: 7f20f8a0-75f9-4365-b00a-a53c6a35b448

Reported adverse events (FAERS/openFDA)#

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