FDA.reportPublic FDA data

Esomeprazole magnesium

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Esomeprazole magnesium
Generic name
ESOMEPRAZOLE MAGNESIUM
Manufacturer
TIME CAP LABORATORIES, INC.
Product type
HUMAN OTC DRUG
SPL set ID
08acf79f-f50d-8416-e063-6294a90a2704
SPL ID
08ad180e-e87a-ba6f-e063-6394a90a2bc7
Version
1
Effective date
2023-11-23
Source export date
2026-08-01
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/0689a4374f1490600b5244071db3b04bd3bbc29ceda7a856edb8225323adf20a/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:00:57
Harmonized routes table
Harmonized routes
ORAL

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 include: -skin reddening -blisters -rash If an allergic reaction occurs, stop use and seek medical attention right away.