Orajel Fluoride

Manufacturer
Church & Dwight Co., Inc.
Effective date
2017-10-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:09:42

Label at a glance#

ProductOrajel Fluoride
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

twist off cap and remove foil seal do not swallow supervise children as necessary until capable of using without supervision adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years: ask a dentist or physician

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride (0.24%)

OTC - PURPOSE SECTION

Anticavity Toothpaste

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental decay

WARNINGS SECTION

Warnings

Keep our of reach of children under 6 years of age

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

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 accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

twist off cap and remove foil seal

do not swallow

supervise children as necessary until capable of using without supervision

adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician

children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing)

children under 2 years: ask a dentist or physician

INACTIVE INGREDIENT SECTION

sorbitol, water, hydrated silica, PEG-8, flavor, cellulose gum, sodium saccharin, sodium lauryl sulfate, blue 1

OTC - QUESTIONS SECTION

Questions of comments Call us at 800 952 5080 Monday through Friday 9 - 5 ET or visit our website at www orajel com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bubble Berry

Orajel

Anticavity

Fluoride

Toothpaste

Disney

Elena

Avalor

NET WT 4.2 OZ (119g)

OJTU-00017-01 (002).jpgOJTU-00017-01 (002).jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10237-773-422024-10-22C16284748780-19d75b9d0-f38e-f424-e053-dadaa90a57ceOrajel Anticavity Fluoride Toothpaste
10237-773-422020-01-31C16284748780-19d75b9d0-f38e-f424-e053-dadaa90a57ceOrajel Anticavity Fluoride Toothpaste

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-77310237-773-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
2518283e-5870-b054-e063-6394a90afb1c5c4ff036-711a-373a-e053-2a91aa0a756a2024-10-22WarningsExact identifier
spl set id: 5c4ff036-711a-373a-e053-2a91aa0a756a

Reported adverse events (FAERS/openFDA)#

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