extra strength headache relief

Generic: acetaminophen, aspirin, and caffeine

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name extra strength headache relief
Generic Name acetaminophen, aspirin, and caffeine
Labeler advanced rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-362
Product ID 80513-362_3f0f7803-0747-baa9-e063-6394a90aac25
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2025-07-01

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 80513362
Hyphenated Format 80513-362

Supplemental Identifiers

RxCUI
308297
UPC
0380513001771
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 extra strength headache relief (source: ndc)
Generic Name acetaminophen, aspirin, and caffeine (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
  • 65 mg/1
source: ndc
Packaging
  • 150 TABLET in 1 BOTTLE (80513-362-15)
source: ndc

Packages (1)

80513-362-15 150 TABLET in 1 BOTTLE (80513-362-15)

Ingredients (3)

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

Linked Drug Pages (1)

Extra Strength Headache Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3f0f7803-0747-baa9-e063-6394a90aac25", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "upc": ["0380513001771"], "unii": ["362O9ITL9D", "R16CO5Y76E", "3G6A5W338E"], "rxcui": ["308297"], "spl_set_id": ["a7ed4c76-a5b5-44f7-866f-f43790e45c78"], "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": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 TABLET in 1 BOTTLE (80513-362-15)", "package_ndc": "80513-362-15", "marketing_start_date": "20250701"}], "brand_name": "Extra Strength Headache Relief", "product_id": "80513-362_3f0f7803-0747-baa9-e063-6394a90aac25", "dosage_form": "TABLET", "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": "80513-362", "generic_name": "Acetaminophen, Aspirin, and Caffeine", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Extra Strength Headache Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "250 mg/1"}, {"name": "ASPIRIN", "strength": "250 mg/1"}, {"name": "CAFFEINE", "strength": "65 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250701", "listing_expiration_date": "20261231"}