ACETAMINOPHEN 500 MG

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 500 MG
Generic name: ACETAMINOPHEN
Manufacturer: NUVICARE LLC
Product type: HUMAN OTC DRUG
SPL set ID: 95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e
SPL ID: d807f30b-98b7-47af-b1b9-fa01e660ffff
Version: 2
Effective date: 2025-12-19
Source export date: 2026-10-30
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/57469fe40e5b1c0d9604dc7dbc22532ea48e8e53acfb911fc676578d98492f7e/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:29:23

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 500 MG	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		NUVICARE LLC	openfda.manufacturer_name
ndc	package	84324-003-01	openfda.package_ndc
ndc	product	84324-003	openfda.product_ndc
ndc11	package	84324000301	derived:openfda.package_ndc
rxcui		198440	openfda.rxcui
spl id		d807f30b-98b7-47af-b1b9-fa01e660ffff	id
spl set id		95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e	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

Reported adverse events (FAERS/openFDA)#

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