excedrin extra strength headache

Generic: acetaminophen, aspirin, caffeine

Labeler: jc world bell wholesale co., inc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name excedrin extra strength headache
Generic Name acetaminophen, aspirin, caffeine
Labeler jc world bell wholesale co., inc
Dosage Form TABLET, FILM COATED
Routes
TOPICAL
Active Ingredients

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

Manufacturer
JC World Bell Wholesale Co., Inc

Identifiers & Regulatory

Product NDC 50269-158
Product ID 50269-158_29f4d22e-da00-b685-e063-6294a90a8a9c
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020802
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

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 50269158
Hyphenated Format 50269-158

Supplemental Identifiers

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

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 extra strength headache (source: ndc)
Generic Name acetaminophen, aspirin, caffeine (source: ndc)
Application Number NDA020802 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 65 mg/1
source: ndc
Packaging
  • 25 POUCH in 1 BOX (50269-158-01) / 2 TABLET, FILM COATED in 1 POUCH
  • 6 BLISTER PACK in 1 BOX (50269-158-02) / 1 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH
  • 6 BLISTER PACK in 1 BOX (50269-158-03) / 2 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH
source: ndc

Packages (3)

50269-158-01 25 POUCH in 1 BOX (50269-158-01) / 2 TABLET, FILM COATED in 1 POUCH 50269-158-02 6 BLISTER PACK in 1 BOX (50269-158-02) / 1 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH 50269-158-03 6 BLISTER PACK in 1 BOX (50269-158-03) / 2 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH

Ingredients (3)

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

Linked Drug Pages (1)

Excedrin Extra Strength Headache ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "29f4d22e-da00-b685-e063-6294a90a8a9c", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "R16CO5Y76E", "3G6A5W338E"], "rxcui": ["209468", "308297"], "spl_set_id": ["29b764c7-3d07-5191-e063-6294a90a9c30"], "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": ["JC World Bell Wholesale Co., Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "25 POUCH in 1 BOX (50269-158-01)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50269-158-01", "marketing_start_date": "20240101"}, {"sample": false, "description": "6 BLISTER PACK in 1 BOX (50269-158-02)  / 1 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50269-158-02", "marketing_start_date": "20240101"}, {"sample": false, "description": "6 BLISTER PACK in 1 BOX (50269-158-03)  / 2 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50269-158-03", "marketing_start_date": "20240101"}], "brand_name": "Excedrin Extra Strength Headache", "product_id": "50269-158_29f4d22e-da00-b685-e063-6294a90a8a9c", "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": "50269-158", "generic_name": "ACETAMINOPHEN, ASPIRIN, CAFFEINE", "labeler_name": "JC World Bell Wholesale Co., Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Excedrin Extra Strength Headache", "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": "20240101", "listing_expiration_date": "20261231"}