headache relief extra strength

Generic: acetaminophen, aspirin and caffeine

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name headache relief extra strength
Generic Name acetaminophen, aspirin and caffeine
Labeler allegiant health
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-285
Product ID 69168-285_62d55418-7d3d-4708-af3a-2969be915e4a
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 69168285
Hyphenated Format 69168-285

Supplemental Identifiers

RxCUI
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 headache relief extra strength (source: ndc)
Generic Name acetaminophen, aspirin 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 (69168-285-37) / 16 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

69168-285-37 1 BOTTLE in 1 CARTON (69168-285-37) / 16 TABLET, FILM COATED in 1 BOTTLE

Ingredients (3)

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

Linked Drug Pages (1)

Headache Relief Extra Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "62d55418-7d3d-4708-af3a-2969be915e4a", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "R16CO5Y76E", "3G6A5W338E"], "rxcui": ["308297"], "spl_set_id": ["6197eff5-0351-42ef-bb3f-cbc26e6d0d14"], "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": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-285-37)  / 16 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "69168-285-37", "marketing_start_date": "20220908"}], "brand_name": "Headache Relief Extra Strength", "product_id": "69168-285_62d55418-7d3d-4708-af3a-2969be915e4a", "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": "69168-285", "generic_name": "Acetaminophen, Aspirin and Caffeine", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Headache Relief", "brand_name_suffix": "Extra Strength", "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"}