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: Rising Pharma Holdings, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: f8237772-7656-49fb-b1de-f8fcb5fa55ee
SPL ID: ffbb6e36-399b-40eb-96b4-b0406c712c0d
Version: 2
Effective date: 2025-10-28
Source export date: 2026-10-30
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/8d15bdc5962e7531569eaeb5b1b2e4919574d40a6782ab67345a27b890175a00/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:58:36

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		Rising Pharma Holdings, Inc.	openfda.manufacturer_name
ndc	package	57237-347-05	openfda.package_ndc
ndc	package	57237-347-01	openfda.package_ndc
ndc	product	57237-347	openfda.product_ndc
ndc11	package	57237034701	derived:openfda.package_ndc
ndc11	package	57237034705	derived:openfda.package_ndc
rxcui		198440	openfda.rxcui
spl id		ffbb6e36-399b-40eb-96b4-b0406c712c0d	id
spl set id		f8237772-7656-49fb-b1de-f8fcb5fa55ee	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 4,000 mg 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 and seek medical help right away.

Reported adverse events (FAERS/openFDA)#

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