Aurophen Regular Strength

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: Aurophen Regular Strength
Generic name: ACETAMINOPHEN
Manufacturer: Aurohealth LLC
Product type: HUMAN OTC DRUG
SPL set ID: 8eda893f-5266-4b7a-95b9-2e194973cf06
SPL ID: 0b463c9c-6ad9-20df-e063-6394a90a427a
Version: 4
Effective date: 2023-11-29
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:14:50

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		Aurophen Regular Strength	openfda.brand_name
generic name		ACETAMINOPHEN	openfda.generic_name
manufacturer name		Aurohealth LLC	openfda.manufacturer_name
ndc	package	58602-754-21	openfda.package_ndc
ndc	package	58602-754-07	openfda.package_ndc
ndc	package	58602-754-14	openfda.package_ndc
ndc	product	58602-754	openfda.product_ndc
ndc11	package	58602075421	derived:openfda.package_ndc
ndc11	package	58602075414	derived:openfda.package_ndc
ndc11	package	58602075407	derived:openfda.package_ndc
rxcui		313782	openfda.rxcui
spl id		0b463c9c-6ad9-20df-e063-6394a90a427a	id
spl set id		8eda893f-5266-4b7a-95b9-2e194973cf06	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 adult takes more than 4,000 mg of acetaminophen in 24 hours 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 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.