NDC 74094-002 Marshall Toothache Drops

Eugenol 85% (clove Oil 2% V/v)

NDC Product Code 74094-002

NDC CODE: 74094-002

Proprietary Name: Marshall Toothache Drops 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: Eugenol 85% (clove Oil 2% V/v) 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.

Product Characteristics

Color(s):
RED (C48326 - CLEAR RED LIQUID WITH ODOUR OF CLOVE OIL)

NDC Code Structure

  • 74094 - Yashvire Llc

NDC 74094-002-01

Package Description: 1 BOTTLE in 1 CARTON > 10 mL in 1 BOTTLE

NDC Product Information

Marshall Toothache Drops with NDC 74094-002 is a a human over the counter drug product labeled by Yashvire Llc. The generic name of Marshall Toothache Drops is eugenol 85% (clove oil 2% v/v). The product's dosage form is solution/ drops and is administered via dental form.

Labeler Name: Yashvire Llc

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Marshall Toothache Drops 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.

  • EUGENOL 17 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • CARMOISINE (UNII: DR4641L47F)

Administration Route(s)

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

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Yashvire Llc
Labeler Code: 74094
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: 05-17-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Marshall Toothache Drops 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

Otc - Active Ingredient

Drug Facts Active Ingredient: Eugenol 85% (Clove Oil 2% v/v)

Otc - Purpose

Purpose: Surface Anaesthetic

Indications & Usage

Uses: Acts as a surface anaesthetic temporarily relieving a toothache due to a cavity, until a dentist can be seen.

Warnings

  • Warnings: For external use only. Allergy alert: do not use if you are allergic to clove oil. When using this product: Use only in teeth with persistent throbbing pain.Avoid touching tissues other than tooth cavityDO NOT SWALLOW to avoid irritation.Do not use for more than 48 hours.Do NOT use more than the recommended dose.Stop use and ask a dentist or doctor if. irritation persists, inflammation develops, or if fever and infection develop.See a dentist as soon as possible whether or not the pain is relieved. Toothaches and open cavities indicate serious problems that need prompt attention by a dentist.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directions for Use:Adults and Children over 12 years:Rinse tooth with water to remove any food particles from the cavityApply 1-2 drops to a piece of cotton woolSwab affected area with the cotton wool or plug into affected cavityLeave in tooth cavity for 1 minute without touching surrounding tissues, then remove and discard.Discontinue use if irritation occurs. Avoid contact with cheek, gums, palate and lipsSupervise children using this productUse up to 4 times daily or as directed by a dentist or doctor.

Other Safety Information

Other information. Do not purchase if package has been opened.


Store at 46 – 90 F. (8 – 32


oC). Cap tightly to avoid evaporation.

Inactive Ingredient

Inactive ingredients:
Ethyl alcohol, Purified water, Carmoisine red dye

* Please review the disclaimer below.