Atuss Da
NDC 58407-252

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 58407-252?
  4. Atuss Da Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Atuss Da is a OTC MONOGRAPH FINAL-approved product labeled by Magna Pharmceuticals, Inc.. This combination medication is used to relieve symptoms caused by the common cold, flu, allergies, "hay fever," and other breathing illnesses (such as sinusitis, bronchitis). It is supplied as a product. This product entry covers the primary NDC 58407-252 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
58407-252
Proprietary Name:
Atuss Da
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Magna Pharmceuticals, Inc.
Labeler Code:
58407
Product Label ID:
7ba8db45-f5b6-5d32-e053-2991aa0a77b7
FDA Application Number: [6]
part341
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Marketing Timeline

Start Marketing Date: [9]
11-20-2018
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 58407-252?

The NDC code 58407-252 is assigned by the FDA to the product Atuss Da. This pharmaceutical product is labeled by Magna Pharmceuticals, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 58407-252-01, 58407-252-04, 58407-252-16. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This combination medication is used to relieve symptoms caused by the common cold, flu, allergies, "hay fever," and other breathing illnesses (such as sinusitis, bronchitis). These symptoms include cough, watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. This product contains a cough suppressant (such as chlophedianol) that affects a certain part of the brain, reducing the urge to cough. This product also contains a decongestant (such as pseudoephedrine, phenylephrine), which helps relieve stuffy nose symptoms. It also contains an antihistamine (such as brompheniramine, triprolidine, among others), which helps relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. This medication is not usually used for ongoing coughs from smoking, asthma, or other long-term breathing problems (such as emphysema), or for coughs with a lot of mucus, unless directed by your doctor. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated 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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

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: 1014331 - brompheniramine maleate 2 MG / chlophedianol HCl 12.5 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution
  • RxCUI: 1014331 - brompheniramine maleate 0.4 MG/ML / chlophedianol hydrochloride 2.5 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution
  • RxCUI: 1014331 - brompheniramine maleate 2 MG / chlophedianol hydrochloride 12.5 MG / pseudoephedrine hydrochloride 30 MG per 5 ML Oral Solution

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".