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NDC 0363-6504 Walgreen Childrens Cold Plus Cough Plus Sore Throat

Acetaminophen And Dextromethorphan Hydrobromide Suspension Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0363-6504?
  5. Walgreen Childrens Cold Plus Cough Plus Sore Throat Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
0363-6504
Proprietary Name:
Walgreen Childrens Cold Plus Cough Plus Sore Throat
Non-Proprietary Name: [1]
Acetaminophen And Dextromethorphan Hydrobromide
Substance Name: [2]
Acetaminophen; Dextromethorphan Hydrobromide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Walgreens Co.
    Labeler Code:
    0363
    Product Label ID:
    801880b2-6116-4d26-a7bf-a669eef6ad8b
    FDA Application Number: [6]
    M012
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    02-24-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

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

    Code Structure Chart

    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 does not contain directions or complete warnings for adult use▪do not give more than directed (see overdose warning) ▪shake well before using▪mL = milliliter▪find right dose on chart below. If possible, use weight to dose; otherwise, use age.▪remove the child protective cap and squeeze your child's dose into the dosing cup▪repeat dose every 4 hours, while symptoms last▪do not give more than 5 times in 24 hoursWeight (lb)Age (yr)Dose (mL)under 36under 4 yearsdo not use36-474 to 5 years5 mL48-956 to 11 years10 mLAttention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

    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:

    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:

    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 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.

    * 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.

    [2] 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.

    [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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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".