Orajel 2x Gum Pain Alcohol-free
Menthol And Hydrogen Peroxide
Church & Dwight Co., Inc.
Human Otc Drug
NDC 10237-799Orajel 2x Gum Pain Alcohol-free also known as Menthol And Hydrogen Peroxide is a human otc drug labeled by 'Church & Dwight Co., Inc.'. National Drug Code (NDC) number for Orajel 2x Gum Pain Alcohol-free is 10237-799. This drug is available in dosage form of Rinse. The names of the active, medicinal ingredients in Orajel 2x Gum Pain Alcohol-free drug includes Hydrogen Peroxide - 15 mg/mL Menthol, Unspecified Form - 1 mg/mL . The currest status of Orajel 2x Gum Pain Alcohol-free drug is Active.
Drug Information:
| Drug NDC: | 10237-799 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Orajel 2x Gum Pain Alcohol-free |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Orajel 2x Gum Pain |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Alcohol-Free |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Menthol And Hydrogen Peroxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Church & Dwight Co., Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Rinse |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HYDROGEN PEROXIDE - 15 mg/mL
MENTHOL, UNSPECIFIED FORM - 1 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 15 Jan, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part356 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Church & Dwight Co., Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2584344
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | BBX060AN9V
L7T10EIP3A
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 10237-799-16 | 473.2 mL in 1 BOTTLE, PLASTIC (10237-799-16) | 15 Jan, 2023 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Active ingredients purpose hydrogen peroxide 1.5% oral debriding agent/oral antiseptic menthol 0.1% oral pain reliever
Product Elements:
Orajel 2x gum pain alcohol-free menthol and hydrogen peroxide menthol, unspecified form menthol, unspecified form hydrogen peroxide hydrogen peroxide edetate disodium anhydrous fd&c blue no. 1 methyl salicylate phosphoric acid poloxamer 338 polysorbate 20 propylene glycol saccharin sodium sorbitol water
Indications and Usage:
Uses first aid to help reduce bacteria in minor oral wounds for temporary pain relief and use in cleansing minor wounds or minor gum inflammation resulting from: minor dental procedures accidental injury orthodontic appliances canker sores dentures other irritations of the mouth and gums aids in the removal of: phlegm mucus other secretions associated with occasional sore mouth
Warnings:
Warnings do not use this product for more than 7 days unless directed by a dentist or healthcare provider when using this product do not swallow do not exceed recommended dosage stop use and see your physician promptly if swelling, rash or fever develops irritation, pain or redness persists or worsens sore 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
Do Not Use:
Warnings do not use this product for more than 7 days unless directed by a dentist or healthcare provider when using this product do not swallow do not exceed recommended dosage stop use and see your physician promptly if swelling, rash or fever develops irritation, pain or redness persists or worsens sore 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
When Using:
When using this product do not swallow do not exceed recommended dosage
Dosage and Administration:
Directions remove imprinted safety seal from bottle cap to remove child-resistant cap, squeeze smooth sides of cap while turning. reclose tightly. ready to use, no mixing needed. adults and children 2 years of age and older swish one-half capful (2 teaspoons = 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 provider children under 12 years of age should be supervised in the use of this product children under 2 years of age consult a dentist or healthcare provider
Stop Use:
Stop use and see your physician promptly if swelling, rash or fever develops irritation, pain or redness persists or worsens sore mouth symptoms do not improve in 7 days
Package Label Principal Display Panel:
Principal display panel - 473.2 ml bottle label 1# oral pain relief brand for adults orajel ⢠2x gum pain rinse medicated alcohol free effective oral pain relief â soothes & cools gums â kills harmful bacteria â promotes healing â relieves gum irritation caused by dentures or braces oral debriding agent/ antiseptic rinse/pain reliever soothing mint 16 fl oz (473.2 ml) ojlbf-01904-01 72025286 principal display panel - 473.2 ml bottle label
Further Questions:
Questions or comments? call us at 1-800-952-5080 mâf 9amâ5pm et or visit our website at www.orajel.com