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: Kroger Company
Product type: HUMAN OTC DRUG
SPL set ID: bc17b2e5-4828-6a2e-e053-2995a90a8c63
SPL ID: 584661fe-3b55-4d7d-e063-6294a90acdaa
Version: 5
Effective date: 2026-08-05
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:37:33

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 · 17 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		Kroger Company	openfda.manufacturer_name
ndc	package	41226-341-50	openfda.package_ndc
ndc	package	41226-341-15	openfda.package_ndc
ndc	package	41226-341-10	openfda.package_ndc
ndc	package	41226-341-01	openfda.package_ndc
ndc	product	41226-341	openfda.product_ndc
ndc11	package	41226034101	derived:openfda.package_ndc
ndc11	package	41226034115	derived:openfda.package_ndc
ndc11	package	41226034150	derived:openfda.package_ndc
ndc11	package	41226034110	derived:openfda.package_ndc
rxcui		198440	openfda.rxcui
spl id		584661fe-3b55-4d7d-e063-6294a90acdaa	id
spl set id		bc17b2e5-4828-6a2e-e053-2995a90a8c63	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.