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NDC 0363-4590 Daytime Cold And Cough And Nighttime Cold And Congestion Childrens

Brompheniramine Maleate,Dextromethorphan Hbr,Phenylephrine Hcl,Diphenhydramine - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0363-4590?
  5. Daytime Cold And Cough And Nighttime Cold And Congestion Childrens Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
0363-4590
Proprietary Name:
Daytime Cold And Cough And Nighttime Cold And Congestion Childrens
Non-Proprietary Name: [1]
Brompheniramine Maleate, Dextromethorphan Hbr, Phenylephrine Hcl, Diphenhydramine Hcl, Phenylephrine Hcl
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]
Walgreens
Labeler Code:
0363
Product Label ID:
2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3
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]
03-04-2022
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Flavor(s):
GRAPE (C73391)

Product Packages

NDC Code 0363-4590-08

Package Description: 1 KIT in 1 KIT * 118 mL in 1 BOTTLE, PLASTIC * 118 mL in 1 BOTTLE, PLASTIC

Product Details

What is NDC 0363-4590?

The NDC code 0363-4590 is assigned by the FDA to the product Daytime Cold And Cough And Nighttime Cold And Congestion Childrens which is a human over the counter drug product labeled by Walgreens. The generic name of Daytime Cold And Cough And Nighttime Cold And Congestion Childrens is brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl, phenylephrine hcl. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0363-4590-08 1 kit in 1 kit * 118 ml in 1 bottle, plastic * 118 ml in 1 bottle, plastic. 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 Daytime Cold And Cough And Nighttime Cold And Congestion Childrens?

Nighttimedo not take more than 6 doses in any 24 hours period do not exceed recommended dosage measure only with dosing cup provided. Do not use any other dosing device keep dosing cup with product mL = mililiterAgeDose  adults and children 12 years and over 20 mL every 4 hours childen 6 to under 12 years 10 mL every 4 hours children under 6 years do not useDaytimedo not take more than 6 doses in any 24 hours period measure only with dosing cup provided. Do not use any other dosing dosing device. keep dosing cup with product mL = mililiter Age Dose  adults and children12 years and over 20 mL every 4 hours children 6 to under 11 years 10 mL every 4 hours Children under 6 years do not use

Which are Daytime Cold And Cough And Nighttime Cold And Congestion Childrens UNII Codes?

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

Which are Daytime Cold And Cough And Nighttime Cold And Congestion Childrens 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 Daytime Cold And Cough And Nighttime Cold And Congestion Childrens?

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: 1090463 - brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1090463 - brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1090463 - brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution
  • RxCUI: 1090463 - brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution
  • RxCUI: 1236048 - diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution

* Please review the disclaimer below.

Patient Education

Brompheniramine


Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
[Learn More]


Dextromethorphan


Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
[Learn More]


Diphenhydramine


Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
[Learn More]


Phenylephrine


Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
[Learn More]


* 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".