NDC 82939-000 Orca Complete Menthol Pain Reliever
Menthol Liquid Oral

Product Information

Product Code82939-000
Proprietary Name 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.
Orca Complete Menthol Pain Reliever
Non-Proprietary Name 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.
Menthol
Product Type 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.
Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Orca Products, Llc
Labeler Code82939
FDA Application Number 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.
part356
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-15-2022
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

Usage Information


Product Packages

NDC 82939-000-01

Package Description: 1 BOTTLE, GLASS in 1 BOX > 10 mL in 1 BOTTLE, GLASS

Product Details

Orca Complete Menthol Pain Reliever is a human over the counter drug product labeled by Orca Products, Llc. The generic name of Orca Complete Menthol Pain Reliever is menthol. The product's dosage form is liquid and is administered via oral form.


What are Orca Complete Menthol Pain Reliever Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


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.

  • CLOVE OIL (UNII: 578389D6D0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GUAIACOL (UNII: 6JKA7MAH9C)
  • OREGANO LEAF OIL (UNII: 7D0CGR40U1)
  • PEPPERMINT OIL (UNII: AV092KU4JH)


* Please review the disclaimer below.

Orca Complete Menthol Pain Reliever Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Drug Facts




Active Ingredient



Menthol 2%


Purpose



oral pain reliever


Use



  • for the temporary relief of pain due to minor irritation or injury of the mouth and gums

Warnings




Do Not Use



  • this product for more than 7 days unless directed by a dentist or doctor.

When Using This Product



  • do not exceed recommended dosage.

Stop Use And Ask A Doctor If



  • sore mouth symptoms do not improve in 7 days 
  • irritation, pain, or redness persists or worsens 
  • swelling, rash, or fever develops

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact Poison Control Center right away.


Directions



  • Adults and children 12 years of age and older: Place 8-10 drops onto ORCA Foam or similar reabsorbable gelatin sponge or gauze strip in a sterile fashion and apply to areas of discomfort in oral region. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in use of this product.
  • Children under 12 years of age: Consult a dentist or doctor.

Other Information



  • Do not use if tamperproof seal is not intact at time of first use.

Inactive Ingredients



Clove oil, glycerin, guaiacol, oregano oil, peppermint oil.


Questions?



1-970-401-1138 MON-FRI 8 AM to 3 PM (CST)


* Please review the disclaimer below.