NDC 71165-172 Gems Cherry

Menthol

NDC Product Code 71165-172

NDC CODE: 71165-172

Proprietary Name: Gems Cherry 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.

Product Characteristics

Color(s):
RED (C48326)
Shape: SQUARE (C48350)
Size(s):
18 MM
Imprint(s):
G
Score: 1
Flavor(s):
CHERRY (C73375)

NDC Code Structure

NDC 71165-172-02

Package Description: 9 LOZENGE in 1 PACKAGE

NDC Product Information

Gems Cherry with NDC 71165-172 is a a human over the counter drug product labeled by Riclan S.a.. The generic name of Gems Cherry is menthol. The product's dosage form is lozenge and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 253015.

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.

Gems Cherry 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.


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.

  • CORN SYRUP (UNII: 9G5L16BK6N)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • SUCROSE (UNII: C151H8M554)
  • WATER (UNII: 059QF0KO0R)

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: Riclan S.a.
Labeler Code: 71165
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: 09-13-2021 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.

Gems Cherry Product Label Images

Gems Cherry 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

Active Ingredient (In Each Drop)

Menthol 7 mg

Purpose

Cough suppressant/oral anesthetic

Uses

  • Temporarily relieves:cough due to a coldoccasional minor irritation or sore throat

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, rash, swelling, nausea, or vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days unless directed by a doctor.

Ask A Doctor Before Use If You Have

  • Persistent or chronic cough such as occurs with smoking, asthma, or emphysemacough accompanied by excessive phlegm (mucus)

Stop Use And Ask A Doctor If

  • Sore mouth does not improve in 7 dayscough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.irritation, pain, or redness persists or worsens

Directions

  • Do not take more than directedadults and children 5 years and over: dissolve 1 drop slowly in the mouth. Repeat every 2 hours as needed.children under 5 years: ask a doctor

Other Information

  • 12 calories per dropContains: SOY

Inactive Ingredients

Corn syrup, eucalyptus oil, FD&C red #40, natural & artificial flavors, soy lecithin, sucrose, water

* Please review the disclaimer below.