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: CHAIN DRUG MARKETING ASSOCIATION INC
Product type: HUMAN OTC DRUG
SPL set ID: cfc7eac3-35be-4002-b8ef-be1dfc8caf69
SPL ID: 8c4fdac0-f82f-4975-a01f-e5d1de264e24
Version: 2
Effective date: 2024-12-26
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 05:57:38

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 · 11 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		CHAIN DRUG MARKETING ASSOCIATION INC	openfda.manufacturer_name
ndc	package	63868-678-60	openfda.package_ndc
ndc	product	63868-678	openfda.product_ndc
ndc11	package	63868067860	derived:openfda.package_ndc
rxcui		307668	openfda.rxcui
spl id		8c4fdac0-f82f-4975-a01f-e5d1de264e24	id
spl set id		cfc7eac3-35be-4002-b8ef-be1dfc8caf69	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 your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. When using this product do not exceed recommended dose (see overdose warning)

Reported adverse events (FAERS/openFDA)#

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