panadol extra

Generic: acetaminophen and caffeine

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name panadol extra
Generic Name acetaminophen and caffeine
Labeler haleon us holdings llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, caffeine 65 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0135-0620
Product ID 0135-0620_10c0dc3d-12b7-e9da-e063-6394a90a5dcf
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2017-03-01

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 01350620
Hyphenated Format 0135-0620

Supplemental Identifiers

RxCUI
307686 1872075
UNII
362O9ITL9D 3G6A5W338E
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 panadol extra (source: ndc)
Generic Name acetaminophen and caffeine (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 65 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0135-0620-01) / 24 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

0135-0620-01 1 BOTTLE in 1 CARTON (0135-0620-01) / 24 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

acetaminophen (500 mg/1) caffeine (65 mg/1)

Linked Drug Pages (1)

PANADOL Extra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "10c0dc3d-12b7-e9da-e063-6394a90a5dcf", "openfda": {"nui": ["N0000175739", "N0000175729", "N0000175790", "M0023046"], "unii": ["362O9ITL9D", "3G6A5W338E"], "rxcui": ["307686", "1872075"], "spl_set_id": ["e5c2d88a-d903-4ca0-b895-f27e791dfc4e"], "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": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0135-0620-01)  / 24 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "0135-0620-01", "marketing_start_date": "20170301"}], "brand_name": "PANADOL Extra", "product_id": "0135-0620_10c0dc3d-12b7-e9da-e063-6394a90a5dcf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Central Nervous System Stimulant [EPC]", "Central Nervous System Stimulation [PE]", "Methylxanthine [EPC]", "Xanthines [CS]"], "product_ndc": "0135-0620", "generic_name": "acetaminophen and caffeine", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PANADOL", "brand_name_suffix": "Extra", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "CAFFEINE", "strength": "65 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170301", "listing_expiration_date": "20261231"}