Esomeprazole Magnesium

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: Esomeprazole Magnesium
Generic name: ESOMEPRAZOLE MAGNESIUM
Manufacturer: CVS Pharmacy, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 1867185e-9c34-c8cc-e063-6394a90ab3b1
SPL ID: c7b8460b-d1da-41d9-b644-157718295382
Version: 2
Effective date: 2024-07-09
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:07:57

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	214473	derived:openfda.application_number
application number		ANDA214473	openfda.application_number
brand name		Esomeprazole Magnesium	openfda.brand_name
generic name		ESOMEPRAZOLE MAGNESIUM	openfda.generic_name
manufacturer name		CVS Pharmacy, Inc.	openfda.manufacturer_name
ndc	package	51316-088-01	openfda.package_ndc
ndc	package	51316-088-05	openfda.package_ndc
ndc	product	51316-088	openfda.product_ndc
ndc11	package	51316008801	derived:openfda.package_ndc
ndc11	package	51316008805	derived:openfda.package_ndc
rxcui		433733	openfda.rxcui
spl id		c7b8460b-d1da-41d9-b644-157718295382	id
spl set id		1867185e-9c34-c8cc-e063-6394a90ab3b1	set_id
unii		36H71644EQ	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 Allergy alert: ■ Do not use if you are allergic to esomeprazole. ■ Esomeprazole may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If an allergic 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.