excedrin migraine

Generic: acetaminophen, aspirin (nsaid) and caffeine

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name excedrin migraine
Generic Name acetaminophen, aspirin (nsaid) and caffeine
Labeler haleon us holdings llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 250 mg/1, aspirin 250 mg/1, caffeine 65 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-8201
Product ID 0067-8201_ebe1d05e-a2d6-4092-a101-0c283ac6f95d
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020802
Listing Expiration 2026-12-31
Marketing Start 2010-02-15

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc] platelet aggregation inhibitor [epc] central nervous system stimulant [epc] methylxanthine [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs] xanthines [cs]
Physiologic Effect
decreased prostaglandin production [pe] decreased platelet aggregation [pe] central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00678201
Hyphenated Format 0067-8201

Supplemental Identifiers

RxCUI
209468 308297
UNII
362O9ITL9D R16CO5Y76E 3G6A5W338E
NUI
N0000000160 N0000008836 M0001335 N0000175722 N0000175578 N0000008832 N0000175739 N0000175729 N0000175790 M0023046

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name excedrin migraine (source: ndc)
Generic Name acetaminophen, aspirin (nsaid) and caffeine (source: ndc)
Application Number NDA020802 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 65 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0067-8201-03) / 300 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

0067-8201-03 1 BOTTLE in 1 CARTON (0067-8201-03) / 300 TABLET, FILM COATED in 1 BOTTLE

Ingredients (3)

acetaminophen (250 mg/1) aspirin (250 mg/1) caffeine (65 mg/1)

Linked Drug Pages (1)

EXCEDRIN MIGRAINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ebe1d05e-a2d6-4092-a101-0c283ac6f95d", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "R16CO5Y76E", "3G6A5W338E"], "rxcui": ["209468", "308297"], "spl_set_id": ["920c8898-e222-4b91-afc5-04d25317ade7"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]", "Xanthines [CS]"], "pharm_class_pe": ["Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]", "Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]", "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0067-8201-03)  / 300 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0067-8201-03", "marketing_start_date": "20200325"}], "brand_name": "EXCEDRIN MIGRAINE", "product_id": "0067-8201_ebe1d05e-a2d6-4092-a101-0c283ac6f95d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "0067-8201", "generic_name": "Acetaminophen, Aspirin (NSAID) and Caffeine", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "EXCEDRIN", "brand_name_suffix": "MIGRAINE", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "ASPIRIN", "strength": "250 mg/1"}, {"name": "CAFFEINE", "strength": "65 mg/1"}], "application_number": "NDA020802", "marketing_category": "NDA", "marketing_start_date": "20100215", "listing_expiration_date": "20261231"}