Dinosaur

Manufacturer
LMZ
Effective date
2021-05-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:08

Label at a glance#

Productdinosaur
Active ingredientSODIUM FLUORIDE
Label structure10 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. Do not swallow. To minimize swallowing use a pea sized amount in children under 6 years. Supervise children’s brushing until good habits are established. Children under 2 years of age, consult a dentist or physician.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% Anti-Cavity
(0.10% w/w fluoride ion) Toothpaste

Purpose

OTC - PURPOSE SECTION

Anti-Cavity
Toothpaste

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of cavities.

Warnings

WARNINGS SECTION

If you accidentally swallow
more than used for brushing, get medical
help or contact a Poison Control Center
immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

Do Not Use

OTC - DO NOT USE SECTION

Do not use if inner foil is torn, cut or missing.

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.

  • Do not swallow.
  • To minimize swallowing use a pea sized amount in children under 6 years.
  • Supervise children’s brushing until good habits are established.
  • Children under 2 years of age, consult a dentist or physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Hydrated Silica, PEG-8, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Saccharin, Sodium Benzoate, Xylitol, Trisodium Phosphate, Xanthan Gum, Acid Blue 9, Allura Red AC

Questions or comments?

OTC - QUESTIONS SECTION

1-800-558-6684

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24g NDC: 71775-070-54 24000 mg Dinosaur24000 mg Dinosaur

120g NDC: 71775-070-52

120000 mg Dinosaur120000 mg Dinosaur

24g NDC: 71775-070-55

Great Shark 24gGreat Shark 24g

120g NDC: 71775-070-53

Shark 120gShark 120g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71775-070-522023-01-30C16284748780-1f386c649-da55-0266-e053-dadaa90a7c1aPlak Smacker
71775-070-532023-01-30C16284748780-1f386c649-da55-0266-e053-dadaa90a7c1aPlak Smacker
71775-070-542023-01-30C16284748780-1f386c649-da55-0266-e053-dadaa90a7c1aPlak Smacker
71775-070-552023-01-30C16284748780-1f386c649-da55-0266-e053-dadaa90a7c1aPlak Smacker

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71775-070-52dinosaur120 g in 1 TUBEPASTE1202
71775-070-53dinosaur120 g in 1 TUBEPASTE1202
71775-070-54dinosaur24 g in 1 TUBEPASTE242
71775-070-55dinosaur24 g in 1 TUBEPASTE242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71775-070DINOSAUR (SODIUM FLUORIDE) PASTE [LMZ]2Legacy NDC, 4 package rows20210503_bb9ef774-370c-1479-e053-2995a90a525a.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71775-07071775-070-54, 71775-070-52, 71775-070-55, 71775-070-53

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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
c1491f6d-3400-f38c-e053-2a95a90acf0ebb9ef774-370c-1479-e053-2995a90a525a2021-05-01WarningsExact identifier
spl id: c1491f6d-3400-f38c-e053-2a95a90acf0e
spl set id: bb9ef774-370c-1479-e053-2995a90a525a

Reported adverse events (FAERS/openFDA)#

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