Outrageous Orange Anticavity - OFT51 MRT

Manufacturer
Tom's of Maine, Inc.
Effective date
2026-07-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-07-18 05:10:10

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Purpose

Anticavity

Uses

Use

helps protect against cavities

Warnings

Warnings

Directions And Dosage

Directions

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

Other Label Information

Inactive ingredients

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?

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

PRINCIPAL DISPLAY PANEL - 144 g Tube Label

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

Label Images#

toms-01
toms-01

DailyMed Product Concepts#

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

Products#

NDC Codes#

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

Ingredients#

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

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

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

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

Source Document#

Source XML

Older Hydrated Versions#

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