FDA.reportPublic FDA data

Cardinal Health

Manufacturer
Cardinal Health 200, LLC
Effective date
2024-06-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:00:33

Label at a glance#

ProductCardinal Health
Active ingredientSODIUM FLUORIDE
Label structure7 sections

Indications and uses

Aids in the prevention of dental cavities

Dosage and administration

Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or directed by a dentist or physician. Instruct children under 6yrs of age in good brushing and rinsing habits (to minimize swallowing). Use a pea-size amount for children under 6. Supervise children as necessary until capable of using without supervision. Children under 2 yrs. of age: Consult a dentist or physician.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% (0.15% w/v Fluoride Ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6yrs. of age. If you accidentally swallow more than used for brushing, seek medical help or contact a Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 yrs. and older: brush teeth thoroughly after meals or at least twice a day or directed by a dentist or physician. Instruct children under 6yrs of age in good brushing and rinsing habits (to minimize swallowing). Use a pea-size amount for children under 6. Supervise children as necessary until capable of using without supervision. Children under 2 yrs. of age: Consult a dentist or physician.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica, Water, Glycerin, PEG 12, Sodium Lauryl Sulfate, Titanium Dioxide, Cellulose Gum, Flavor, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin, FD&C Blue #1

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

anticavity toothpaste with fluoride

ADA Accepted American Dental Association

Cardinal Health™

net wt 0.85 oz (24 g)

NDC 63517-0702-1

REF OC-TPASTE

Distributed by: Cardinal Health, Waukegan, IL USA 60085

Rev.A 2020-11 • OC-TPASTE (F)

© 2020 Cardinal Health. All Rights Reserved.

cardinalhealth.com/symbolsglossary

Cardinal_Toothpaste_image.jpgCardinal_Toothpaste_image.jpg

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63517-070CARDINAL HEALTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [CARDINAL HEALTH 200, LLC]3Legacy NDC20240619_b850287c-d71f-01a7-e053-2a95a90aa036.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
63517-07063517-070-21

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
MINTFV98Z8GITPIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TIACT
WATER059QF0KO0RIACT

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
1b2ab70b-919d-b36b-e063-6294a90abdebb850287c-d71f-01a7-e053-2a95a90aa0362024-06-18WarningsExact identifier
spl id: 1b2ab70b-919d-b36b-e063-6294a90abdeb
spl set id: b850287c-d71f-01a7-e053-2a95a90aa036

Reported adverse events (FAERS/openFDA)#

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