NDC 0067-8203 Excedrin Extra Strength Pain Reliever

Acetaminophen,Aspirin (nsaid),And Caffeine Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0067-8203
Proprietary Name:
Excedrin Extra Strength Pain Reliever
Non-Proprietary Name: [1]
Acetaminophen, Aspirin (nsaid), And Caffeine
Substance Name: [2]
Acetaminophen; Aspirin; Caffeine
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Haleon Us Holdings Llc
    Labeler Code:
    0067
    FDA Application Number: [6]
    M013
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    01-15-2021
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE)
    Shape:
    OVAL (C48345)
    Size(s):
    17 MM
    Imprint(s):
    ES
    Score:
    1

    Product Packages

    NDC Code 0067-8203-02

    Package Description: 1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 0067-8203-03

    Package Description: 1 BOTTLE in 1 CARTON / 200 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 0067-8203-04

    Package Description: 1 BOTTLE in 1 CARTON / 300 TABLET, FILM COATED in 1 BOTTLE

    Product Details

    What is NDC 0067-8203?

    The NDC code 0067-8203 is assigned by the FDA to the product Excedrin Extra Strength Pain Reliever which is a human over the counter drug product labeled by Haleon Us Holdings Llc. The generic name of Excedrin Extra Strength Pain Reliever is acetaminophen, aspirin (nsaid), and caffeine. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 0067-8203-02 1 bottle in 1 carton / 100 tablet, film coated in 1 bottle, 0067-8203-03 1 bottle in 1 carton / 200 tablet, film coated in 1 bottle, 0067-8203-04 1 bottle in 1 carton / 300 tablet, film coated 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 Excedrin Extra Strength Pain Reliever?

    •do not use more than directed•drink a full glass of water with each dose•adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours •children under 12 years: ask a doctor

    What are Excedrin Extra Strength Pain Reliever 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 250 mg/1 - 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.
    • ASPIRIN 250 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)
    • CAFFEINE 65 mg/1 - A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine's most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes SMOOTH MUSCLE, stimulates CARDIAC MUSCLE, stimulates DIURESIS, and appears to be useful in the treatment of some types of headache. Several cellular actions of caffeine have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide PHOSPHODIESTERASES, antagonism of ADENOSINE RECEPTORS, and modulation of intracellular calcium handling.

    Which are Excedrin Extra Strength Pain Reliever UNII Codes?

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

    Which are Excedrin Extra Strength Pain Reliever 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 Excedrin Extra Strength Pain Reliever?

    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: 209468 - EXCEDRIN 250 MG / 250 MG / 65 MG Oral Tablet
    • RxCUI: 209468 - acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]
    • RxCUI: 209468 - APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]
    • RxCUI: 209468 - Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet
    • RxCUI: 209468 - Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral Tablet

    Which are the Pharmacologic Classes for Excedrin Extra Strength Pain Reliever?

    * 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".