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NDC 0363-1739 Severe Cold Dm Severe Cold And Flu

Acetaminophen,Dextromethorphan Hydrobromide,Phenylephrine Hydrochloride,Diphenhydramine - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0363-1739?
  5. Severe Cold Dm Severe Cold And Flu Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
0363-1739
Proprietary Name:
Severe Cold Dm Severe Cold And Flu
Non-Proprietary Name: [1]
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Diphenhydramine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Walgreen Company
Labeler Code:
0363
Product Label ID:
0e138ee3-7e22-4b0f-9f1f-8c51b5ddf62b
FDA Application Number: [6]
part341
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date: [9]
05-24-2022
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - MIXTURE OF WHITE, LIGHT YELLOW-ORANGE PARTICLES)
ORANGE (C48331)
Flavor(s):
HONEY (C73394 - GREEN TEA)
LEMON (C73396 - GREEN TEA)

Code Structure Chart

Product Details

What is NDC 0363-1739?

The NDC code 0363-1739 is assigned by the FDA to the product Severe Cold Dm Severe Cold And Flu which is a human over the counter drug product labeled by Walgreen Company. The generic name of Severe Cold Dm Severe Cold And Flu is acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, diphenhydramine hydrochloride. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0363-1739-55 1 kit in 1 carton * 1 powder, for solution in 1 packet (0363-1919-00) * 1 powder, for solution in 1 packet (0363-1357-00). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Severe Cold Dm Severe Cold And Flu?

•do not use more than directed (see overdose warning)•take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor.AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not use•dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.•if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat. •do not use more than directed (see overdose warning)•take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.AgeDoseadults and children 12 years of age and overone packetchildren under 12 years of agedo not use•dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.•if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

Which are Severe Cold Dm Severe Cold And Flu UNII Codes?

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

Which are Severe Cold Dm Severe Cold And Flu 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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Severe Cold Dm Severe Cold And Flu?

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: 1189316 - acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution
  • RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution
  • RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution
  • RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
  • RxCUI: 1189316 - APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution

* Please review the disclaimer below.

Product Footnotes

[1] 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.

[3] 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.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] 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] 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] 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".