NDC 73282-0013 Drkids Childrens Cough And Chest Congestion Dm

Dextromethorphan Hydrobromide, Guaifenesin

NDC Product Code 73282-0013

NDC CODE: 73282-0013

Proprietary Name: Drkids Childrens Cough And Chest Congestion Dm 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: Dextromethorphan Hydrobromide, Guaifenesin 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

BERRY (C73365)

NDC Code Structure

  • 73282 - Calmco Llc
    • 73282-0013 - Drkids Childrens Cough And Chest Congestion Dm

NDC 73282-0013-1

Package Description: 20 VIAL in 1 CARTON > 5 mL in 1 VIAL

NDC Product Information

Drkids Childrens Cough And Chest Congestion Dm with NDC 73282-0013 is a a human over the counter drug product labeled by Calmco Llc. The generic name of Drkids Childrens Cough And Chest Congestion Dm is dextromethorphan hydrobromide, guaifenesin. The product's dosage form is solution and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1020138.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Drkids Childrens Cough And Chest Congestion Dm 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.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)

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: Calmco Llc
Labeler Code: 73282
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: 08-06-2021 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.

Drkids Childrens Cough And Chest Congestion Dm Product Label Images

Drkids Childrens Cough And Chest Congestion Dm 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 5Ml)

Dextromethorphan HBr, USP, 5mgGuaifenesin, USP, 100mg


Cough suppressantExpectorant


  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a coldhelps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive

Do Not Use

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

Ask A Doctor Before Use If Your Child Has

Persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus).

Stop Use And Ask A Doctor If

Cough lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.


In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Do not give more than 6 doses in any 24 hour period

give the recommended number of vials below, following the instructions under How to Open and Use on the side panel

empty all liquid in each Single-Use Vial when dosing
Dosing Chart
Age (Years) Dose under 4 yearsConsult a doctor 4 – 5 years 1 Single-Use Vial (5 mL) every 4 hours 6 – 11 years 1 – 2 Single-Use Vials (5 mL each) every 4 hours Adults and children 12 years and over 2 – 4 Single-Use Vials (5 mL each) every 4 hours

Inactive Ingredients

Citric acid, glycerin, mixed berry flavor, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum

Other Information

  • Each Single-Use vial contains 6mg of sodiumstore at 20-25ºC (68-77ºF)tamper evident: do not use if top flap of carton is open. Do not use if any vials are open or broken

* Please review the disclaimer below.