NDC 10237-778 Orajel Denture Pain Relief

Benzocaine, Menthol, Zinc Chloride

NDC Product Information

Orajel Denture Pain Relief with NDC 10237-778 is a a human over the counter drug product labeled by Church & Dwight Co., Inc.. The generic name of Orajel Denture Pain Relief is benzocaine, menthol, zinc chloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Church & Dwight Co., Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Orajel Denture Pain Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZOCAINE 200 mg/g
  • MENTHOL 26 mg/g
  • ZINC CHLORIDE 1.5 mg/g

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Church & Dwight Co., Inc.
Labeler Code: 10237
FDA Application Number: part356 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-18-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Orajel Denture Pain Relief Product Label Images

Orajel Denture Pain Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Benzocaine 20%Menthol 0.7%Zinc Chloride 0.15%

Otc - Purpose

Benzocaine - Oral Pain RelieverMenthol - Oral Pain RelieverZinc Chloride - Oral Astringent

Indications & Usage

Use for the temporary relief of • pain due to minor irritation of the mouth and gums caused by dentures • occasional minor irritation, pain, sore mouth.


Warnings• Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Otc - Do Not Use

Do not use • more than directed • for more than 7 days unless directed by a physician or healthcare provider

Otc - Stop Use

Stop use and ask a physician if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Cut open tube on score markAdults and children 2 years of age and over:Apply a thin layer to the affected area. Do not reinsert dental work until irritation/pain is relieved. Rinse out well before reinserting. Use up to 4 times daily or as directed by a physician or healthcare provider.Children under 12 years of age:Should be supervised in the use of this productChildren under 2 years of age:Ask a physician or healthcare providerOther Information • do not sue if tube tip is cut prior to opening • this preparation is intended for use in cases of denture pain, only as a temporary expedent until a physician can be consulted • do not use continuously • Orajel Denture Pain Gel will stay in place for extended duration of relief

Inactive Ingredient

Inactive Ingredients blue 1, cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin, water

Otc - Questions

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

* Please review the disclaimer below.