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: Family Dollar Stores, LLC
Product type: HUMAN OTC DRUG
SPL set ID: f86ba9b5-736e-b279-e053-6394a90acf7c
SPL ID: 4007a63d-482e-4afb-9cbc-46d02c3692ac
Version: 3
Effective date: 2024-04-27
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:44:24

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	209339	derived:openfda.application_number
application number		ANDA209339	openfda.application_number
brand name		Esomeprazole Magnesium	openfda.brand_name
generic name		ESOMEPRAZOLE MAGNESIUM	openfda.generic_name
manufacturer name		Family Dollar Stores, LLC	openfda.manufacturer_name
ndc	package	55319-051-03	openfda.package_ndc
ndc	package	55319-051-05	openfda.package_ndc
ndc	product	55319-051	openfda.product_ndc
ndc11	package	55319005105	derived:openfda.package_ndc
ndc11	package	55319005103	derived:openfda.package_ndc
rxcui		606726	openfda.rxcui
spl id		4007a63d-482e-4afb-9cbc-46d02c3692ac	id
spl set id		f86ba9b5-736e-b279-e053-6394a90acf7c	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.