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: CVS Pharmacy, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: e577fdf0-85b1-1471-e053-2995a90a6fcd
SPL ID: 8394aaec-e897-48bb-bda2-cc2b64a6cd64
Version: 5
Effective date: 2024-01-24
Source export date: 2026-10-27
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/2c7d3f7bcea1543046130e07dcbaf7eea5fb0ce23f7faa6458d1c6d80c3fa0c3/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:43:53

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	207229	derived:openfda.application_number
application number		ANDA207229	openfda.application_number
brand name		Acetaminophen	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		CVS Pharmacy, Inc.	openfda.manufacturer_name
ndc	package	69842-635-07	openfda.package_ndc
ndc	product	69842-635	openfda.product_ndc
ndc11	package	69842063507	derived:openfda.package_ndc
rxcui		1148399	openfda.rxcui
spl id		8394aaec-e897-48bb-bda2-cc2b64a6cd64	id
spl set id		e577fdf0-85b1-1471-e053-2995a90a6fcd	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 6 tablets 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 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.