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: RETAIL BUSINESS SERVICES,LLC.
Product type: HUMAN OTC DRUG
SPL set ID: a0fb0afe-9c25-d0f6-e053-2995a90adbba
SPL ID: 4651bbcf-6529-2fb3-e063-6294a90a0e8f
Version: 7
Effective date: 2025-12-19
Source export date: 2026-09-28
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:05:32

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 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	211544	derived:openfda.application_number
application number		ANDA211544	openfda.application_number
brand name		Acetaminophen	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		RETAIL BUSINESS SERVICES,LLC.	openfda.manufacturer_name
ndc	package	72476-185-05	openfda.package_ndc
ndc	package	72476-185-10	openfda.package_ndc
ndc	package	72476-185-21	openfda.package_ndc
ndc	product	72476-185	openfda.product_ndc
ndc11	package	72476018505	derived:openfda.package_ndc
ndc11	package	72476018510	derived:openfda.package_ndc
ndc11	package	72476018521	derived:openfda.package_ndc
rxcui		1148399	openfda.rxcui
spl id		4651bbcf-6529-2fb3-e063-6294a90a0e8f	id
spl set id		a0fb0afe-9c25-d0f6-e053-2995a90adbba	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 · 2 matching rows.

warnings

Liver warning This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 6 caplets in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks every day while using this product

warnings and cautions

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.