NDC 0280-0060 Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz

Aspirin,Chlorpheniramine Maleate,Phenylephrine Bitartrate Tablet, Effervescent Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0280-0060
Proprietary Name:
Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz
Non-Proprietary Name: [1]
Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate
Substance Name: [2]
Aspirin; Chlorpheniramine Maleate; Phenylephrine Bitartrate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Effervescent - A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Code:
    0280
    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]
    06-15-2021
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    ROUND (C48348)
    Size(s):
    25 MM
    Imprint(s):
    ALKA;SELTZERPLUS
    Score:
    1
    Flavor(s):
    LEMON (C73396)

    Code Structure Chart

    Product Details

    What is NDC 0280-0060?

    The NDC code 0280-0060 is assigned by the FDA to the product Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz which is a human over the counter drug product labeled by Bayer Healthcare Llc.. The generic name of Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz is aspirin, chlorpheniramine maleate, phenylephrine bitartrate. The product's dosage form is tablet, effervescent and is administered via oral form. The product is distributed in 5 packages with assigned NDC codes 0280-0060-01 10 pouch in 1 carton / 2 tablet, effervescent in 1 pouch, 0280-0060-02 18 pouch in 1 carton / 2 tablet, effervescent in 1 pouch, 0280-0060-03 2 pouch in 1 carton / 2 tablet, effervescent in 1 pouch, 0280-0060-04 12 pouch in 1 carton / 2 tablet, effervescent in 1 pouch, 0280-0060-05 2 tablet, effervescent in 1 pouch . 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 Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz?

    Temporarily relieves these symptoms due to a cold:minor aches and painsheadacherunny nosenasal congestionsneezingsore throatsinus congestion and pressuretemporarily reduces fever

    What are Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz 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.
    • ASPIRIN 325 mg/1 - The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5)
    • CHLORPHENIRAMINE MALEATE 2 mg/1 - A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.
    • PHENYLEPHRINE BITARTRATE 7.8 mg/1

    Which are Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz UNII Codes?

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

    Which are Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz 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 Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz?

    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: 1536840 - aspirin 325 MG / chlorpheniramine maleate 2 MG / phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet
    • RxCUI: 1536840 - ASA 325 MG / Chlorpheniramine Maleate 2 MG / Phenylephrine bitartrate 7.8 MG Effervescent Oral Tablet

    Which are the Pharmacologic Classes for Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz?

    * 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".