NDC 73408-815 Thompson Cherry Cough Drops

Menthol

NDC Product Code 73408-815

NDC CODE: 73408-815

Proprietary Name: Thompson Cherry Cough 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: 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: OVAL (C48345)
Size(s):
22 MM
Imprint(s):
P
Score: 1
Flavor(s):
CHERRY (C73375)

NDC Code Structure

  • 73408 - Thompson Safety Llc

NDC 73408-815-50

Package Description: 50 LOZENGE in 1 BOX

NDC Product Information

Thompson Cherry Cough Drops with NDC 73408-815 is a a human over the counter drug product labeled by Thompson Safety Llc. The generic name of Thompson Cherry Cough Drops 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: 359751.

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.

Thompson Cherry Cough 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.


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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • SUCROSE (UNII: C151H8M554)

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: Thompson Safety Llc
Labeler Code: 73408
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: 08-11-2021 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.

Thompson Cherry Cough Drops Product Label Images

Thompson Cherry Cough 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

Other

Drug Facts

Otc - Active Ingredient

Active ingredient (each drop)Menthol 7.6 mg

Otc - Purpose

PurposeAntitussive (cough suppressant)/oral anesthetic

Indications & Usage

UsesTemporarily relieves■ cough as may occur with a cold or inhaled irritants■ occasional minor irritation and sore throat

Warnings

WarningsSore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. These symptoms may be serious.

Otc - Ask Doctor

  • Ask a doctor before use if you havepersistent or chronic cough such as occurs with smoking, asthma, or emphysemacough accompanied by excessive phlegm (mucus)

Otc - Stop Use

  • Stop use and ask a doctor ifcough 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.sore mouth does not improve in 7 daysirritation, pain, or redness persists or worsens

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

Dosage & Administration

  • Directionsdo not use more than directed​Adults and children:(12 years and older)Allow 1 drop to dissolve slowly in the mouth. May be repeated every 2 hours as necessary or as directed by a doctor.Children under 12 years:ask a doctor

Other Safety Information

  • Other information15 calories per dropstore at 59-86°F (15°-30°C)protect from moisture & heat

Inactive Ingredient

Inactive ingredientscherry flavor, corn syrup, eucalyptus oil, FD&C red #40 lake, sucrose

Otc - Questions

Questions or comments? 877.506.4291

* Please review the disclaimer below.