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: Southern Sales & Service, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 8b838af4-a74d-47b4-952e-dcf5598b08e1
SPL ID: 0b57cdc0-3b62-26fd-e063-6394a90ad4fa
Version: 5
Effective date: 2023-11-29
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:17:43

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		Southern Sales & Service, Inc.	openfda.manufacturer_name
ndc	package	69822-692-10	openfda.package_ndc
ndc	product	69822-692	openfda.product_ndc
ndc11	package	69822069210	derived:openfda.package_ndc
rxcui		313782	openfda.rxcui
spl id		0b57cdc0-3b62-26fd-e063-6394a90ad4fa	id
spl set id		8b838af4-a74d-47b4-952e-dcf5598b08e1	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

• Liver warning Warnings this product contains Acetaminophen. Severe liver damage may occur if adult takes more than 12 tablets in 24 hours, which is the maximum daily amount child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product

Reported adverse events (FAERS/openFDA)#

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