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: American Health Packaging
Product type: HUMAN OTC DRUG
SPL set ID: 88e5345a-f240-473c-b329-2b0aa5f081f9
SPL ID: 4a0449b1-7dd9-f323-e063-6294a90ac587
Version: 1
Effective date: 2026-02-04
Source export date: 2026-11-06
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 06:50:41

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 · 14 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		American Health Packaging	openfda.manufacturer_name
ndc	package	60687-924-21	openfda.package_ndc
ndc	package	60687-924-11	openfda.package_ndc
ndc	product	60687-924	openfda.product_ndc
ndc11	package	60687092421	derived:openfda.package_ndc
ndc11	package	60687092411	derived:openfda.package_ndc
rxcui		1148399	openfda.rxcui
spl id		4a0449b1-7dd9-f323-e063-6294a90ac587	id
spl set id		88e5345a-f240-473c-b329-2b0aa5f081f9	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.