Outrageous Orange Anticavity - OFT51 MRT

Manufacturer
Tom's of Maine, Inc.
Effective date
2026-08-10
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-08-20 01:01:17

Label at a glance#

ProductTOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGO
Active ingredientSODIUM MONOFLUOROPHOSPHATE
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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.14% 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, benzyl alcohol, tetrasodium pyrophosphate, sodium lauryl sulfate, carrageenan, natural flavor, Citrus limon (Lemon) juice, Mangifera indica (Mango) juice, Citrus aurantium dulcis (Orange) juice, Ananas sativus (Pineapple) fruit juice, Fragaria ananassa (Strawberry) fruit juice.

Questions?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 144 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

THE ORIGINAL
Tom's
OF MAINE

Kid's
• NATURAL •

fluoride
anticavity toothpaste

fights cavities
tastes great • dye free

ages
2+

OUTRAGEOUS
ORANGE MANGO

NET WT
5.1 OZ
(144 g)

BRUSH
RECYCLE*
SMILE

PRINCIPAL DISPLAY PANEL - 144 g Tube Label
PRINCIPAL DISPLAY PANEL - 144 g Tube Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130035000971210GTIN-13: 0035000971210
EAN-13: 0035000971210
GTIN-12: 035000971210
UPC-A: 035000971210
GTIN storage (14 digits): 00035000971210
toms-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51009-91151009-911-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62026-07-13daily-update2026-07-18 05:10:10
52026-07-02weekly-update2026-07-17 21:44:04
42026-03-09full-release2026-06-01 01:55:51

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
TOMS OF MAINE KIDS OUTRAGEOUS ORANGE MANGOSODIUM MONOFLUOROPHOSPHATETom's of Maine, Inc.19de1e71-ab94-415f-b66d-e5748dea83172026-08-10WarningsExact identifier
ndc (package): 51009-911-51
ndc (product): 51009-911
ndc11 (package): 51009091151
spl id: 9282883d-c97c-44e6-bfd4-f815aed5cef0
spl set id: 19de1e71-ab94-415f-b66d-e5748dea8317

Reported adverse events (FAERS/openFDA)#

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