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
TRIFECTA PHARMACEUTICALS USA LLC
Product type
HUMAN OTC DRUG
SPL set ID
2999fecb-cb15-4023-ade4-ab5822b094d5
SPL ID
1286af63-33fc-5b93-e063-6294a90a9717
Version
10
Effective date
2024-02-29
Source export date
2026-09-28
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/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:52:58
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 ●avoid contact with the eyes ●do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop using this product and ask a doctor ● in case of bleeding if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days before you begin using any other hydrocortisone product. Do not use this product and ask a doctor ● if you have a vaginal discharge ● before treating diaper rash ● before using on children under 2 years of age. For External Anal Itching Users: ● do not exceed the recommended daily dosage unless directed by a doctor ● in case of bleeding, consult a doctor promptly ● do not put this product into the rectum by using fingers or any mechanical device or applicator ● children under 12 years of age: consult a doctor Before using any medication, read all label directions. Keep this carton. It contains important information.

Reported adverse events (FAERS/openFDA)#

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