Acetaminophen

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
Generic name: ACETAMINOPHEN
Manufacturer: WALGREENS
Product type: HUMAN OTC DRUG
SPL set ID: 8f8d43d1-8e73-483e-e053-2a95a90ac99b
SPL ID: 4652e567-f625-3c68-e063-6394a90a6610
Version: 8
Effective date: 2025-12-19
Source export date: 2026-10-12
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:45:19

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 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	211544	derived:openfda.application_number
application number		ANDA211544	openfda.application_number
brand name		Acetaminophen	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		WALGREENS	openfda.manufacturer_name
ndc	package	0363-9992-20	openfda.package_ndc
ndc	package	0363-9992-10	openfda.package_ndc
ndc	package	0363-9992-24	openfda.package_ndc
ndc	product	0363-9992	openfda.product_ndc
ndc11	package	00363999220	derived:openfda.package_ndc
ndc11	package	00363999210	derived:openfda.package_ndc
ndc11	package	00363999224	derived:openfda.package_ndc
rxcui		1148399	openfda.rxcui
spl id		4652e567-f625-3c68-e063-6394a90a6610	id
spl set id		8f8d43d1-8e73-483e-e053-2a95a90ac99b	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 · 2 matching rows.

warnings

Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 6 caplets 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

warnings and cautions

Allergy alert acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away.

Reported adverse events (FAERS/openFDA)#

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