NDC 10237-784 Orajel Antiseptic Alcohol-free Mouth Sore Rinse

Hydrogen Peroxide, Menthol

NDC Product Code 10237-784

NDC CODE: 10237-784

Proprietary Name: Orajel Antiseptic Alcohol-free Mouth Sore Rinse What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydrogen Peroxide, Menthol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 10237 - Church & Dwight Co., Inc.
    • 10237-784 - Orajel Antiseptic Alcohol-free Mouth Sore Rinse

NDC 10237-784-16

Package Description: 473.2 mL in 1 BOTTLE

NDC Product Information

Orajel Antiseptic Alcohol-free Mouth Sore Rinse with NDC 10237-784 is a a human over the counter drug product labeled by Church & Dwight Co., Inc.. The generic name of Orajel Antiseptic Alcohol-free Mouth Sore Rinse is hydrogen peroxide, menthol. The product's dosage form is liquid and is administered via oral 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.

Orajel Antiseptic Alcohol-free Mouth Sore Rinse 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.

  • MENTHOL 1 mg/mL
  • HYDROGEN PEROXIDE 1.5 mg/mL

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.

  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN (UNII: FST467XS7D)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • POLOXAMER 338 (UNII: F75JV2T505)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

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: 11-01-2019 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 Antiseptic Alcohol-free Mouth Sore Rinse Product Label Images

Orajel Antiseptic Alcohol-free Mouth Sore Rinse 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

Active Ingredients

Hydrogen peroxide 1.5%Menthol 0.1%

Purpose

Oral debriding agent/Oral antiseptic, Oral pain reliever

Uses

  • First aid to help reduce bacteria in minor oral woundsfor temporary pain relief anduse in cleansing minor wounds or minor gum inflammation resulting from:
  • Minor dental proceduresorthodontic appliancesdenturesaccidental injurycanker soresother irritations of the mouth and gumsAids in the removal of:phlegmmucusother secretions associated with occasional sore mouth

Warnings

  • Do not use this product for more than 7 days unless directed by a dentist or healthcare provider
  • When using this productdo not swallowdo not exceed recommended dosage

Stop Use

  • Stop Use and see your physician promptly ifswelling, rash or fever developsirritations, pain or redness persists or worsenssore mouth symptoms do not improve in 7 days

Keep Out Of Reach Of Children

If more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away

Directions

  • Adults and children 2 years of age and olderSwish one-half capful (2 tesapoons=10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare providerChildren under 12 years of ageShould be supervised in the use of this productChildren under 2 years of ageConsult a dentist or healthcare provider

Other Information

  • Cap tightlykeep away from heat or direct sunlightdo not use if safety seal is broken or missing

Inactive Ingredients

Blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, propylene glycol, sodium saccharin, sorbitol, water

* Please review the disclaimer below.