NDC 10237-777 Benzocaine

Orajel Severe Toothache

NDC Product Code 10237-777

NDC 10237-777-45

Package Description: 1 BOTTLE, GLASS in 1 CARTON > 13.3 mg in 1 BOTTLE, GLASS

NDC Product Information

Benzocaine with NDC 10237-777 is a a human over the counter drug product labeled by Church & Dwight Co., Inc.. The generic name of Benzocaine is orajel severe toothache. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Church & Dwight Co., Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Benzocaine 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 g/mg
  • MENTHOL 10 g/mg

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • ALCOHOL (UNII: 3K9958V90M)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • WATER (UNII: 059QF0KO0R)

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.

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: 07-31-2019 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.

Benzocaine Product Label Images

Benzocaine 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 0.1%

Otc - Purpose

Oral Pain Reliever

Indications & Usage

Use for the temporary relief of pain due to • canker sores • minor injury of the mouth and gum • minor irritation of the mouth and gums caused by dentures or orthodontic appliances


Methemoglobinemia warning: Use of this product may cuse methemoglobinemia, a serious condition that must be treated promptly becasue it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray or blue colored skin (cyanosis) • headache • rapid heart rate • shortness or breath • dizziness or lightheadedness • fatigue or lack of engery
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
Flammable: keep away from fire or flame. Avoid smoking during application.

Otc - Do Not Use

Do not use • more than directed • for more than 7 days unless directed by a dentistor doctor •for teething •in children under 2 years of age

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

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

  • Directions • remove imprinted safety seal from bottle cap
  • Adults and children 2 years of age and overApply product with cotton swab or finger to the affected area. Use up to 4 times daily or as directed by a dentist or doctorChildren under 12 years of ageAsk a doctor before use. Should be supervised in the use of this productChildren under 2 years of ageDo not useOther Information • do not use if safety seal on bottle cap is broken or missing prior to opening •

Inactive Ingredient

Inactive Ingredients alcohol (54.5% by volume), flavor, PEG-8, red 40, sodium saccarin, water, yellow 5

Otc - Questions

Questions or comment? Call us at
800 952 5080 M-F 9am-5pm or visit our website at
www orajel.com

* Please review the disclaimer below.