Mckesson Orasol Gel

Benzocaine 20%

Mckesson Medical-surgical
Human Otc Drug
NDC 68599-8247

Mckesson Orasol Gel also known as Benzocaine 20% is a human otc drug labeled by 'Mckesson Medical-surgical'. National Drug Code (NDC) number for Mckesson Orasol Gel is 68599-8247. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Mckesson Orasol Gel drug includes Benzocaine - 200 mg/g . The currest status of Mckesson Orasol Gel drug is Active.

Drug Information:

Drug NDC:	68599-8247
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:	Mckesson Orasol Gel
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 20%
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Mckesson Medical-surgical
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
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
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:	04 Oct, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	22 Dec, 2025
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, 2023
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:	McKesson Medical-Surgical
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	238910
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.
NUI:	N0000185508 N0000175629 N0000184306 M0000728
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	U3RSY48JW5
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
68599-8247-4	75 PACKET in 1 BOX (68599-8247-4) / .75 g in 1 PACKET	04 Oct, 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

Oral Pain Relief Gel

Benzocaine 20%

Gel
Sled Distribution, LLC
NDC: 81417-121

Mckesson Orasol Gel

Benzocaine 20%

Gel
McKesson Medical-Surgical
NDC: 68599-8247

Oral Pain Relief Gel

Benzocaine 20%

Gel
Sled Distribution, LLC
NDC: 81417-001

Purpose:

Purpose oral anesthetic

Product Elements:

Mckesson orasol gel benzocaine 20% polyethylene glycol 3350 polyethylene glycol 400 peppermint oil saccharin sodium benzocaine benzocaine sorbic acid

Indications and Usage:

Uses for the temporary relief of minor pain and sore mouth associated with toothache, minor dental procedures and irritations from dentures or orthodontic appliances.

Warnings:

Warnings for oral use only. do not exceed recommended dosage. 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 the blood. this can occur even if you have used this product before. stop use and seek medical attention if you or a child in your care develops: pale, gray or blue colored skin (cyanosis) rapid heart rate dizziness or lightheadedness headache shortness of breath 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 âcaineâ anesthetics. if a skin reaction occurs, stop use and seek medical help right away.

Do Not Use:

When Using:

When using this product avoid contact with eyes

Dosage and Administration:

Directions adults and children (2 years and older): dry affected area and apply medication undiluted. use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor. children under 2 years: do not use

Stop Use:

Stop use and ask a dentist or doctor if sore mouth does not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, fever or other allergic reaction develops

Package Label Principal Display Panel:

Ndc 68599-8247-4 mckesson orasol gel individual packets benzocaine 20% | oral anesthetic temporary relief of minor pain and sore mouth. net wt 0.75 g 75 packs per box do not reuse mfr # 82474 mckesson

Further Questions:

Questions or comments? call 1-800-777-4908

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.