NDC 0363-6504 Walgreen Childrens Cold Plus Cough Plus Sore Throat
Acetaminophen And Dextromethorphan Hydrobromide Suspension Oral

Product Information

NDC Product Code0363-6504
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.		Walgreen Childrens Cold Plus Cough Plus Sore Throat
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.		Acetaminophen And Dextromethorphan Hydrobromide
Substance Name What is the Substance Name?
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.		Acetaminophen; Dextromethorphan Hydrobromide
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
NDC Directory StatusACTIVE PRODUCT and included in NDC Directory
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.		Walgreens Co.
Labeler Code0363
SPL SET ID:801880b2-6116-4d26-a7bf-a669eef6ad8b
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.		part341
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.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
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.		02-24-2023
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.		12-31-2024
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

Product Characteristics

Color(s)PINK (C48328)
Flavor(s)BUBBLE GUM (C73368)

Product Packages

NDC Code 0363-6504-04

Package Description: 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE

Product Details

What is NDC 0363-6504?

The NDC code 0363-6504 is assigned by the FDA to the product Walgreen Childrens Cold Plus Cough Plus Sore Throat which is a human over the counter drug product labeled by Walgreens Co.. The generic name of Walgreen Childrens Cold Plus Cough Plus Sore Throat is acetaminophen and dextromethorphan hydrobromide. 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 0363-6504-04 1 bottle in 1 carton / 120 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 and RxNorm crosswalk.

What are the uses for Walgreen Childrens Cold Plus Cough Plus Sore Throat?

This product is used as Active ingredients (in each 5 mL)PurposesAcetaminophen 160 mgPain reliever/fever reducerDextromethorphan HBr 5 mgCough suppressant. ▪temporarily relieves the following cold/flu symptoms: ▪minor aches and pains▪headache▪sore throat▪cough▪temporarily reduces fever

What are Walgreen Childrens Cold Plus Cough Plus Sore Throat 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.
  • ACETAMINOPHEN 160 mg/5mL - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • DEXTROMETHORPHAN HYDROBROMIDE 5 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.

Which are Walgreen Childrens Cold Plus Cough Plus Sore Throat UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Walgreen Childrens Cold Plus Cough Plus Sore Throat?

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: 1370113 - acetaminophen 160 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension
  • RxCUI: 1370113 - acetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension
  • RxCUI: 1370113 - acetaminophen 160 MG / dextromethorphan HBr 5 MG per 5 ML Oral Suspension
  • RxCUI: 1370113 - APAP 160 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension
  • RxCUI: 1370113 - APAP 32 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension

Which are Walgreen Childrens Cold Plus Cough Plus Sore Throat 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:

Which are the Pharmacologic Classes for Walgreen Childrens Cold Plus Cough Plus Sore Throat?

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.

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Product Label

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