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
ANTIPRURITIC (ANTI-ITCH)
Manufacturer
BluePoint Laboratories
Product type
HUMAN OTC DRUG
SPL set ID
d6523993-d781-cdbc-e053-2a95a90af191
SPL ID
09bb81fa-759d-b1b7-e063-6394a90aa2c8
Version
5
Effective date
2023-11-17
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 20:34:24
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

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, or if bleeding occurs near anus when used for anal itching Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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