0363-0443 NDC - HEADACHE RELIEF (ACETAMINOPHEN, ASPIRIN AND CAFFEINE)

Drug Information

Product NDC: 0363-0443

Proprietary Name: Headache Relief

Non Proprietary Name: Acetaminophen, Aspirin and Caffeine

Active Ingredient(s):
  • 250 mg/1 ACETAMINOPHEN;
  • 250 mg/1 ASPIRIN;
  • 65 mg/1 CAFFEINE


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED

Pharmacy Class(es):
  • Anti-Inflammatory Agents;
  • Non-Steroidal [CS];
  • Central Nervous System Stimulant [EPC];
  • Central Nervous System Stimulation [PE];
  • Cyclooxygenase Inhibitors [MoA];
  • Decreased Platelet Aggregation [PE];
  • Decreased Prostaglandin Production [PE];
  • Methylxanthine [EPC];
  • Nonsteroidal Anti-inflammatory Drug [EPC];
  • Platelet Aggregation Inhibitor [EPC];
  • Xanthines [CS]

Labeler Information

Labeler Name: Walgreen Company
Product Type: HUMAN OTC DRUG
FDA Application Number: part343
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:3/13/2008
End Marketing Date:7/12/2023

Package Information

No. Package Code Package Description Billing Unit
10363-0443-081 BOTTLE, PLASTIC in 1 CARTON (0363-0443-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTICEA
20363-0443-121 BOTTLE, PLASTIC in 1 CARTON (0363-0443-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC Record

Field Name Field Value Definition
PRODUCT NDC0363-0443The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEHeadache ReliefThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXExtra StrengthA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEAcetaminophen, Aspirin and CaffeineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/13/2008This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE7/12/2023This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct 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.
APPLICATION NUMBERpart343This 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.
LABELER NAMEWalgreen CompanyName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACETAMINOPHEN; ASPIRIN; CAFFEINEAn 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.
ACTIVE NUMERATOR STRENGTH250; 250; 65 
ACTIVE INGRED UNITmg/1; mg/1; mg/1 
PHARM CLASSESAnti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 2/1/2023