acetaminophen , caffeine and pyrilamine maleate

Generic: acetaminophen , caffeine and pyrilamine maleate

Labeler: softgel healthcare pvt ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen , caffeine and pyrilamine maleate
Generic Name acetaminophen , caffeine and pyrilamine maleate
Labeler softgel healthcare pvt ltd
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, caffeine 60 mg/1, pyrilamine maleate 15 mg/1

Manufacturer
Softgel Healthcare Pvt Ltd

Identifiers & Regulatory

Product NDC 35916-0710
Product ID 35916-0710_47dc39ad-82e8-6501-e063-6394a90ad52f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2027-12-31
Marketing Start 2025-12-12

Pharmacologic Class

Established (EPC)
central nervous system stimulant [epc] methylxanthine [epc]
Chemical Structure
xanthines [cs]
Physiologic Effect
central nervous system stimulation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 359160710
Hyphenated Format 35916-0710

Supplemental Identifiers

RxCUI
701913
UNII
362O9ITL9D 3G6A5W338E R35D29L3ZA
NUI
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 , caffeine and pyrilamine maleate (source: ndc)
Generic Name acetaminophen , caffeine and pyrilamine maleate (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 60 mg/1
  • 15 mg/1
source: ndc
Packaging
  • 1500 CAPSULE, LIQUID FILLED in 1 BAG (35916-0710-1)
source: ndc

Packages (1)

35916-0710-1 1500 CAPSULE, LIQUID FILLED in 1 BAG (35916-0710-1)

Ingredients (3)

acetaminophen (500 mg/1) caffeine (60 mg/1) pyrilamine maleate (15 mg/1)

Linked Drug Pages (1)

Acetaminophen , Caffeine and pyrilamine maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47dc39ad-82e8-6501-e063-6394a90ad52f", "openfda": {"nui": ["N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "3G6A5W338E", "R35D29L3ZA"], "rxcui": ["701913"], "spl_set_id": ["45478958-ad86-4d87-e063-6394a90a3c45"], "pharm_class_cs": ["Xanthines [CS]"], "pharm_class_pe": ["Central Nervous System Stimulation [PE]"], "pharm_class_epc": ["Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]"], "manufacturer_name": ["Softgel Healthcare Pvt Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1500 CAPSULE, LIQUID FILLED in 1 BAG (35916-0710-1)", "package_ndc": "35916-0710-1", "marketing_start_date": "20251212"}], "brand_name": "Acetaminophen , Caffeine and pyrilamine maleate", "product_id": "35916-0710_47dc39ad-82e8-6501-e063-6394a90ad52f", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "35916-0710", "generic_name": "Acetaminophen , Caffeine and pyrilamine maleate", "labeler_name": "Softgel Healthcare Pvt Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen , Caffeine and pyrilamine maleate", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "CAFFEINE", "strength": "60 mg/1"}, {"name": "PYRILAMINE MALEATE", "strength": "15 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251212", "listing_expiration_date": "20271231"}