NDC 0113-7384 Basic Care Cough Dm
Dextromethorphan Polistirex Suspension Oral

Product Information

What is NDC 0113-7384?

The NDC code 0113-7384 is assigned by the FDA to the product Basic Care Cough Dm which is a human over the counter drug product labeled by L. Perrigo Company. The generic name of Basic Care Cough Dm is dextromethorphan polistirex. The product's dosage form is suspension and is administered via oral form. The product is distributed in a single package with assigned NDC code 0113-7384-28 1 bottle in 1 carton / 148 ml in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0113-7384
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.
Basic Care Cough Dm
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.
Dextromethorphan Polistirex
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 FormSuspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
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.
L. Perrigo Company
Labeler Code0113
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.
ANDA091135
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.
ANDA - A product marketed under an approved Abbreviated New Drug Application.
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.
11-29-2018
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

What are the uses for Basic Care Cough Dm?


Product Characteristics

Color(s)ORANGE (C48331)
Flavor(s)ORANGE (C73406)

Product Packages

NDC Code 0113-7384-28

Package Description: 1 BOTTLE in 1 CARTON / 148 mL in 1 BOTTLE

Product Details

What are Basic Care Cough Dm Active Ingredients?

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.
  • DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.

Basic Care Cough Dm Active Ingredients UNII Codes

  • DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
  • DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1373045 - dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension
  • RxCUI: 1373045 - 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension
  • RxCUI: 1373045 - dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension

Basic Care Cough Dm Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Basic Care Cough Dm Product Label

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.

Product Label Table of Contents



Active Ingredient (In Each 5 Ml)



Dextromethorphan polistirex equivalent to 30 mg

dextromethorphan hydrobromide


Purpose



Cough suppressant


Uses



temporarily relieves

  • •cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • •the impulse to cough to help you get to sleep

Do Not Use



if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.


Ask A Doctor Before Use If You Have



  • •chronic cough that lasts as occurs with smoking, asthma or emphysema
  • •cough that occurs with too much phlegm (mucus)

Stop Use And Ask A Doctor If



  • •side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • •cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

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 a Poison Control Center right away (1-800-222-1222).


Directions



  • shake bottle well before use
  • •measure only with dosing cup provided
  • •do not use dosing cup with other products
  • •dose as follows or as directed by doctor
  • •mL = milliliter
  • adults and children 12 years of age and over

    10 mL every 12 hours, not to exceed 20 mL in 24 hours

    children 6 to under 12 years of age

    5 mL every 12 hours, not to exceed 10 mL in 24 hours

    children 4 to under 6 years of age

    2.5 mL every 12 hours, not to exceed 5 mL in 24 hours

    children under 4 years of age

    do not use


Other Information



  • each 5 mL contains: sodium 5 mg
  • •store at 20° to 25°C (68° to 77°F)
  • •dosing cup provided

Inactive Ingredients



D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, flavor, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



Day or Night

Compare to Delsym®

active ingredient

cough DM

Dextromethorphan Polistirex Extended-Release Oral Suspension

Cough Suppressant

12 Hour Cough Relief

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions

Orange-Flavored Liquid

Dosing Cup Included

Alcohol-free

5 FL OZ (148 mL)


* Please review the disclaimer below.