FDA.reportPublic FDA data

Thomas and Friends

Manufacturer
Ashtel Studios, Inc.
Effective date
2018-05-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:55:34

Label at a glance#

ProductThomas and Friends
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Indications and uses

Helps protect teeth against cavities.

Dosage and administration

Adults and children 6 years of age and older: Brush teeth thoroughly after meals or at least twice a day. Use directed by a dentist. Do not swallow. To minimize swallowing, use a pea-sized amount in children under 6 years of age. Supervise children’s brushing until good brushing habit are established. Children under 2 years of age: Ask a dentist.

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243% (0.15% w/v Fluoride Ion)

Purpose

OTC - PURPOSE SECTION

Anticavity Toothpaste

Uses

INDICATIONS & USAGE SECTION

Helps protect teeth against cavities.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

If more than used for brushing is accidently swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:

  • Brush teeth thoroughly after meals or at least twice a day. Use directed by a dentist.
  • Do not swallow.
  • To minimize swallowing, use a pea-sized amount in children under 6 years of age.
  • Supervise children’s brushing until good brushing habit are established.
  • Children under 2 years of age: Ask a dentist.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD&C Blue #1, FD&C Red #40.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature.

OTC - QUESTIONS SECTION

QUESTIONS? COMMENTS? / COMMENTAIRES?
1-877-274-8358 (U.S.A.)
1-909-434-0911 (INTERNATIONAL)
1-888-635-5337 (CANADA)

SPL UNCLASSIFIED SECTION

BUBBLE GUM GOMME À BULLES

ANTICAVITY FLUORIDE TOOTHPASTE DENTIFRICE ANTICARIE AU FLUORURE

make brushing fun!®

For more oral care information,
visit us at / Pour d’autres
renseignements, visitez:
www.brushbuddies.com

DISTR. BY/PAR NORTHERN NATIONAL
SALES INC. TORONTO, ON, M9M 1M7

C.No. DNH/COS/DNH/52

©2017 HIT Entertainment Limited. HIT and the HIT logo are trademarks of HIT Entertainment Limited.

© 2017 Gullane (Thomas) Limited.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-015-012024-01-30C16284748780-11030e365-2ace-111a-e063-dadaa90a10e2Thomas & Friends Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-015-01Thomas and Friends100 mL in 1 TUBEPASTE, DENTIFRICE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-015THOMAS AND FRIENDS (SODIUM FLUORIDE) PASTE, DENTIFRICE [ASHTEL STUDIOS, INC.]3Legacy NDC, 1 package rows20180517_16942293-8df7-4a28-82b0-6eb4c828dc4b.zip

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
70108-01570108-015-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 15001212Z7S33AIACT
XYLITOLVCQ006KQ1EIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT

Source Document#

Source XML

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
001d6e32-4a6b-46ec-b5a8-65fc7b68413f16942293-8df7-4a28-82b0-6eb4c828dc4b2018-05-16WarningsExact identifier
spl id: 001d6e32-4a6b-46ec-b5a8-65fc7b68413f
spl set id: 16942293-8df7-4a28-82b0-6eb4c828dc4b

Reported adverse events (FAERS/openFDA)#

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