NDC 63667-156 Cool Relief Lemon Frost Oral Anesthetic

Menthol

NDC Product Code 63667-156

NDC Code: 63667-156

Proprietary Name: Cool Relief Lemon Frost Oral Anesthetic 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: Menthol 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.


Code Structure
  • 63667 - Ricola Usa Inc.
    • 63667-156 - Cool Relief Lemon Frost Oral Anesthetic

NDC 63667-156-19

Package Description: 19 LOZENGE in 1 PACKAGE

NDC 63667-156-24

Package Description: 24 LOZENGE in 1 PACKAGE

NDC 63667-156-45

Package Description: 45 LOZENGE in 1 PACKAGE

NDC Product Information

Cool Relief Lemon Frost Oral Anesthetic with NDC 63667-156 is a a human over the counter drug product labeled by Ricola Usa Inc.. The generic name of Cool Relief Lemon Frost Oral Anesthetic is menthol. The product's dosage form is lozenge and is administered via oral form.

Labeler Name: Ricola Usa Inc.

Dosage Form: Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.

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.


Cool Relief Lemon Frost Oral Anesthetic 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.

  • MENTHOL 16 mg/1

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.

  • SUCROSE (UNII: C151H8M554)
  • LEMON JUICE (UNII: AGN709ANTJ)
  • HONEY (UNII: Y9H1V576FH)

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.

Labeler Name: Ricola Usa Inc.
Labeler Code: 63667
FDA Application Number: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 04-01-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Cool Relief Lemon Frost Oral Anesthetic Product Label Images

Cool Relief Lemon Frost Oral Anesthetic 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

Drug Facts

PurposeOral anesthetic

Active Ingredient (In Each Drop)

Menthol, 16.0 mg

Uses

  • Temporarily relieves occasional minor irritation and pain associated with:sore mouthsore throat

Warnings

  • Sore throat warnings:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious.

Directions

  • Adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctorchildren under 6 years: ask a doctordo not bite or chew

Other Information

Protect from heat and moisture

Inactive Ingredients

Citric acid, colors (carrot), extract of bee balm and the Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), honey, lemon juice concentrate, starch syrup, sugar

* Please review the disclaimer below.

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