FDA.reportPublic FDA data

Hydrocortisone

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
Hydrocortisone
Generic name
HYDROCORTISONE
Manufacturer
Safetec of America, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
da2b3b2c-11e0-401b-bbd2-d019271d1b3d
SPL ID
10d3fc91-82ae-e8eb-e063-6394a90ae87b
Version
5
Effective date
2024-02-07
Source export date
2026-08-01
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/206e0852f7011b53c21719ec5c68ac6752381d0fcd1d348f7428adad64429e89/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:17:50
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings: For external use only Do not use for the treatment of diaper rash in eyes for feminine itching if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days with any other Hydrocortisone product unless you have consulted a doctor KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.