FDA.reportPublic FDA data

Orajel Complete Protection

Manufacturer
Church & Dwight Co., Inc.
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:10:36

Label at a glance#

ProductOrajel Complete Protection
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure8 sections

Dosage and administration

Do not swallow Supervise children as necessary until capable of using without supervision Rinse away toothpaste residue thoroughly after brushing Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sen...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Sodium Fluoride 0.24% (0.17% w/v Fluoride Ion)Anticavity
Potassium Nitrate 5.0%Tooth Desensitizer

Use

INDICATIONS & USAGE SECTION

  • Aids in the prevention of dental decay
  • Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if irritation occurs and persists.

OTC - WHEN USING SECTION

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

OTC - STOP USE SECTION

Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Do not swallow
  • Supervise children as necessary until capable of using without supervision
  • Rinse away toothpaste residue thoroughly after brushing
  • Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth.
  • Children under 12 years of age: Consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, flavor, sodium lauryl sulfate, sodium saccharin, sodium lauroyl sarcosinate, poloxamer 407, xanthan gum, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-786-5135 Mon.– Fri. 9am–5pm ET or visit www.orajel.com

PRINCIPAL DISPLAY PANEL - 121.9 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

#1 ORAL PAIN RELIEF BRAND

Orajel™

Anticavity Toothpaste
For Sensitive Teeth

DEEP CLEAN MINT

COMPLETE PROTECTION

DEEP CLEANING SENSITIVE TOOTHPASTE

Gently whitens and strengthens enamel
Helps remove plaque bacteria

NET WT 4.3 OZ (121.9 g)

PRINCIPAL DISPLAY PANEL - 121.9 g Tube Carton
PRINCIPAL DISPLAY PANEL - 121.9 g Tube Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-677-12Orajel Complete Protection170 g in 1 TUBEPASTE1703
10237-677-12Orajel Complete Protection2 in 1 CARTONPASTE23
10237-677-43Orajel Complete Protection121.9 g in 1 TUBEPASTE121.93
10237-677-43Orajel Complete Protection1 in 1 CARTONPASTE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-677ORAJEL COMPLETE PROTECTION (SODIUM FLUORIDE) PASTE [CHURCH & DWIGHT CO., INC.]3Current NDC, 4 package rows20240404_daebd16f-d278-446d-8b7a-33add5a74fdd.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10237-67710237-677-43, 10237-677-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
POTASSIUM NITRATERU45X2JN0ZACTIB
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
POLOXAMER 407TUF2IVW3M2IACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
Orajel Complete ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.daebd16f-d278-446d-8b7a-33add5a74fdd2023-12-19WarningsExact identifier
ndc (package): 10237-677-12
ndc (package): 10237-677-43
ndc (product): 10237-677
ndc11 (package): 10237067712
ndc11 (package): 10237067743
spl id: 1b5ce44b-79ef-4d10-b4a0-2b8c3dd67edd
spl set id: daebd16f-d278-446d-8b7a-33add5a74fdd

Reported adverse events (FAERS/openFDA)#

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