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: ASCLEMED USA INC.
Product type: HUMAN OTC DRUG
SPL set ID: db8e6702-88ac-4db2-9dd8-7d0ed997c2b5
SPL ID: 411a7984-fff2-6710-e063-6394a90a1704
Version: 1
Effective date: 2025-10-14
Source export date: 2026-10-12
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:57:10

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 · 21 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		ASCLEMED USA INC.	openfda.manufacturer_name
ndc	package	76420-488-01	openfda.package_ndc
ndc	package	76420-488-60	openfda.package_ndc
ndc	package	76420-488-90	openfda.package_ndc
ndc	package	76420-488-10	openfda.package_ndc
ndc	package	76420-488-30	openfda.package_ndc
ndc	package	76420-488-20	openfda.package_ndc
ndc	product	76420-488	openfda.product_ndc
ndc11	package	76420048810	derived:openfda.package_ndc
ndc11	package	76420048860	derived:openfda.package_ndc
ndc11	package	76420048890	derived:openfda.package_ndc
ndc11	package	76420048801	derived:openfda.package_ndc
ndc11	package	76420048830	derived:openfda.package_ndc
ndc11	package	76420048820	derived:openfda.package_ndc
rxcui		198440	openfda.rxcui
spl id		411a7984-fff2-6710-e063-6394a90a1704	id
spl set id		db8e6702-88ac-4db2-9dd8-7d0ed997c2b5	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 which is the maximum daily amount 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.