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: Trifecta Pharmaceuticals USA LLC
Product type: HUMAN OTC DRUG
SPL set ID: 026bf664-d598-73de-e063-6394a90a9206
SPL ID: 1ab8553b-2249-fd6f-e063-6294a90a684b
Version: 5
Effective date: 2024-06-12
Source export date: 2026-09-28
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/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:53:19

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M013	openfda.application_number
brand name		Acetaminophen	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		Trifecta Pharmaceuticals USA LLC	openfda.manufacturer_name
ndc	package	69396-140-03	openfda.package_ndc
ndc	package	69396-140-01	openfda.package_ndc
ndc	product	69396-140	openfda.product_ndc
ndc11	package	69396014003	derived:openfda.package_ndc
ndc11	package	69396014001	derived:openfda.package_ndc
rxcui		198440	openfda.rxcui
spl id		1ab8553b-2249-fd6f-e063-6294a90a684b	id
spl set id		026bf664-d598-73de-e063-6394a90a9206	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. Sever liver damage may occur if you take more than 4000mg of acetaminophen in 24 hours 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 ad seek medical medical help right away

Reported adverse events (FAERS/openFDA)#

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