ACETAMINOPHEN 500 MG

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: ACETAMINOPHEN 500 MG
Generic name: ACETAMINOPHEN
Manufacturer: Pioneer Life Sciences, LLC
Product type: HUMAN OTC DRUG
SPL set ID: 0d67bb52-7ae3-439e-9e47-4e21eb0ca352
SPL ID: 5fa2212a-3bf2-43db-aedd-858124e4ed1d
Version: 2
Effective date: 2025-12-23
Source export date: 2026-10-27
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/2eee27992d1f29d82f827fd5be42f1314ed39ce4c497af5d81435ac6656a0957/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:27:03

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M013	openfda.application_number
brand name		ACETAMINOPHEN 500 MG	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		Pioneer Life Sciences, LLC	openfda.manufacturer_name
ndc	package	72090-008-01	openfda.package_ndc
ndc	product	72090-008	openfda.product_ndc
ndc11	package	72090000801	derived:openfda.package_ndc
rxcui		198440	openfda.rxcui
spl id		5fa2212a-3bf2-43db-aedd-858124e4ed1d	id
spl set id		0d67bb52-7ae3-439e-9e47-4e21eb0ca352	set_id
unii		362O9ITL9D	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.