FDA.reportPublic FDA data

HYDROCORTISONE

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
HYDROCORTISONE
Generic name
HYDROCORTISONE
Manufacturer
ALLIED TRADE LINK LLC
Product type
HUMAN OTC DRUG
SPL set ID
26bc238d-3bda-0c29-e063-6394a90a35fb
SPL ID
26bc238d-3bdb-0c29-e063-6394a90a35fb
Version
1
Effective date
2024-11-12
Source export date
2026-10-27
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/a73bb3b6a943796a18cd4bcd0917240b579be4636d00e6e39481bafbd8093f69/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 20:34:56
Harmonized routes table
Harmonized routes
TOPICAL

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

For External Use Only If pregnant or breast-feeding, ask a health professional before use Do not use In the eyes For diaper rash For external genital or feminine itching if you have a vaginal discharge More than the recommended daily dosage unless directed by a doctor This product in the rectum by using fingers or any mechanical device or applicator Ask a doctor before use if you are using any other hydrocortisone product Stop use and ask a doctor if Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days (do not continue to use this or any other hydrocortisone product for longer than 7 days) Bleeding occurs due to anal itching

Reported adverse events (FAERS/openFDA)#

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