Orajel For Cold Sores Double Medicated, Cream

Benzocaine And White Petrolatum

Church & Dwight Co., Inc.
Human Otc Drug
NDC 10237-797

Orajel For Cold Sores Double Medicated, Cream also known as Benzocaine And White Petrolatum is a human otc drug labeled by 'Church & Dwight Co., Inc.'. National Drug Code (NDC) number for Orajel For Cold Sores Double Medicated, Cream is 10237-797. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Orajel For Cold Sores Double Medicated, Cream drug includes Benzocaine - 200 mg/g Petrolatum - 736.4 mg/g . The currest status of Orajel For Cold Sores Double Medicated, Cream drug is Active.

Drug Information:

Drug NDC:	10237-797
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 For Cold Sores Double Medicated, Cream
Also known as the trade name. It is the name of the product chosen by the labeler.
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:	Benzocaine And White Petrolatum
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:	Cream
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:	BENZOCAINE - 200 mg/g PETROLATUM - 736.4 mg/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	TOPICAL
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:	18 Jan, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	12 Jun, 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.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000185508 N0000175629 N0000184306 M0000728
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	U3RSY48JW5 4T6H12BN9U
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.
Pharmacologic Class EPC:	Standardized Chemical Allergen [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Allergens [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Standardized Chemical Allergen [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
10237-797-12	1 TUBE in 1 CARTON (10237-797-12) / 3.5 g in 1 TUBE	18 Jan, 2021	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.

Other medicines with the same generic name

Orajel For Cold Sores Double Medicated, Cream

Benzocaine And White Petrolatum

Cream
Church & Dwight Co., Inc.
NDC: 10237-797

Purpose:

Topical anesthetic skin protectant

Product Elements:

Orajel for cold sores double medicated, cream benzocaine and white petrolatum benzocaine benzocaine petrolatum petrolatum cholecalciferol methylparaben mineral oil polyethylene glycol, unspecified prunella vulgaris flowering top vitamin a palmitate .alpha.-tocopherol .alpha.-tocopherol acetate, d- water corn oil

Indications and Usage:

Use temporarily relieves pain, itching and dryness; softens crusts (scabs) associated with â¢ cold sores â¢ fever blisters

Warnings:

Warnings for external use only methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in 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: â¢ pale, gray, or blue colored skin (cyanosis) â¢ headache â¢ rapid heart rate â¢ shortness of breath â¢ dizziness or lightheadedness â¢ fatigue or lack of energy 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

Do Not Use:

Dosage and Administration:

Directions cut open tube of tip on score mark do not use if tip is cut prior to opening adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children betweem 2 and 12 years of age: ask a doctor before use. should be supervised in the use of this product children under 2 years of age: do not use

Package Label Principal Display Panel:

#1 oral pain reliver brand for adults 2 active ingredients orajel instant pain relief for cold sores fast-acting cream double medicated relieves pain & itching moisturizing barrier stays in place paraben free topical anesthetic/skin protectant net wt 0.125 oz (3.5 g) label.jpg

Further Questions:

Questions or comments? call us at 1-800-952-5080 m-f 9am-5pm or visit our website at www.orajel.com

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.