acetaminophen , aspirin and caffeine (35916-0709)

Drug Facts

Product Profile

Brand Name acetaminophen , aspirin and caffeine

Generic Name acetaminophen , aspirin and caffeine

Labeler softgel healthcare pvt ltd

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

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

Manufacturer

Softgel Healthcare Pvt Ltd

Identifiers & Regulatory

Product NDC 35916-0709

Product ID 35916-0709_4543bcb2-7b71-62a7-e063-6394a90a9628

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M013

Listing Expiration 2027-12-31

Marketing Start 2026-01-08

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 359160709

Hyphenated Format 35916-0709

Supplemental Identifiers

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 acetaminophen , aspirin and caffeine (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

1500 CAPSULE in 1 BAG (35916-0709-1)

source: ndc

Packages (1)

35916-0709-1 1500 CAPSULE in 1 BAG (35916-0709-1)

Ingredients (3)

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

Linked Drug Pages (1)

Acetaminophen , Aspirin and Caffeine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "4543bcb2-7b71-62a7-e063-6394a90a9628", "openfda": {"nui": ["N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832", "N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "R16CO5Y76E", "3G6A5W338E"], "spl_set_id": ["4543e156-1deb-666e-e063-6394a90a719c"], "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": ["Softgel Healthcare Pvt Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1500 CAPSULE in 1 BAG (35916-0709-1)", "package_ndc": "35916-0709-1", "marketing_start_date": "20260110"}], "brand_name": "Acetaminophen , Aspirin and Caffeine", "product_id": "35916-0709_4543bcb2-7b71-62a7-e063-6394a90a9628", "dosage_form": "CAPSULE", "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": "35916-0709", "generic_name": "Acetaminophen , Aspirin and Caffeine", "labeler_name": "Softgel Healthcare Pvt Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen , Aspirin and Caffeine", "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": "20260108", "listing_expiration_date": "20271231"}