Aspirin 81mg

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: Aspirin 81mg
Generic name: ASPIRIN ENTERIC COATED TABLETS 81MG
Manufacturer: VITANE PHARMACEUTICALS, INC
Product type: HUMAN OTC DRUG
SPL set ID: 4138d4c0-baa5-1f20-e063-6394a90a788f
SPL ID: 4138d4c0-baa6-1f20-e063-6394a90a788f
Version: 1
Effective date: 2025-10-15
Source export date: 2026-10-12
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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:42:47

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		Aspirin 81mg	openfda.brand_name
generic name		ASPIRIN ENTERIC COATED TABLETS 81MG	openfda.generic_name
manufacturer name		VITANE PHARMACEUTICALS, INC	openfda.manufacturer_name
ndc	package	60577-807-01	openfda.package_ndc
ndc	product	60577-807	openfda.product_ndc
ndc11	package	60577080701	derived:openfda.package_ndc
rxcui		308416	openfda.rxcui
spl id		4138d4c0-baa6-1f20-e063-6394a90a788f	id
spl set id		4138d4c0-baa5-1f20-e063-6394a90a788f	set_id
unii		R16CO5Y76E	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 Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Reported adverse events (FAERS/openFDA)#

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