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: Softgel Healthcare Pvt Ltd
Product type: HUMAN OTC DRUG
SPL set ID: 352bb451-ffdc-411a-e063-6294a90a8cf5
SPL ID: 57593d02-16fb-2611-e063-6294a90ad030
Version: 8
Effective date: 2026-07-24
Source export date: 2026-10-27
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/2026-10-27/d7629e6f844435cfe6cb0cf8c5341c46775ea16c5af42c77a22a2ffe820a2cd2/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:51:03

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 · 15 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		Softgel Healthcare Pvt Ltd	openfda.manufacturer_name
ndc	package	35916-0183-2	openfda.package_ndc
ndc	package	35916-0183-4	openfda.package_ndc
ndc	package	35916-0183-3	openfda.package_ndc
ndc	product	35916-0183	openfda.product_ndc
ndc11	package	35916018304	derived:openfda.package_ndc
ndc11	package	35916018303	derived:openfda.package_ndc
ndc11	package	35916018302	derived:openfda.package_ndc
rxcui		198439	openfda.rxcui
spl id		57593d02-16fb-2611-e063-6294a90ad030	id
spl set id		352bb451-ffdc-411a-e063-6294a90a8cf5	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.