Drugplain

Orajel Complete Protection 5 g/100g

Sodium Fluoride · PASTE · Church & Dwight Co., Inc.

No Recall HistoryCurrently in Shortage
Plain English

Orajel Complete Protection is a paste containing sodium fluoride at 5 g/100g, taken oral. Manufactured by Church & Dwight Co., Inc..

Key Facts

Brand Name
Orajel Complete Protection
Generic Name
Sodium Fluoride
NDC Code (Product)
10237-677
Manufacturer
Church & Dwight Co., Inc.
Strength
5 g/100g
Dosage Form
PASTE
Route
ORAL
Marketing Status
Application #
M021
Marketing Start
01/01/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia170 reports
fatigue159 reports
nausea158 reports
vomiting156 reports
pain154 reports
weight increased154 reports
nasopharyngitis152 reports
type 2 diabetes mellitus145 reports
peripheral swelling144 reports
urticaria143 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

Directions 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.

Warnings

Warnings Do not use if irritation occurs and persists. When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. 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. 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.

Frequently Asked Questions

What is Orajel Complete Protection used for?

Orajel Complete Protection contains Sodium Fluoride. It is a paste taken oral. Consult your doctor for specific uses.

Is Orajel Complete Protection a controlled substance?

Orajel Complete Protection is not classified as a controlled substance by the DEA.

What is the generic name for Orajel Complete Protection?

The generic name for Orajel Complete Protection is Sodium Fluoride. There are 12 other brand versions of Sodium Fluoride.

What is the NDC code for Orajel Complete Protection 5 g/100g?

The NDC (National Drug Code) for Orajel Complete Protection 5 g/100g is 10237-677, listed by Church & Dwight Co., Inc..