FDA.reportPublic FDA data

MEDI-FIRST

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
MEDI-FIRST
Generic name
HYDROCORTISONE ACETATE
Manufacturer
Orazen Inc
Product type
HUMAN OTC DRUG
SPL set ID
aeffd85c-58a7-4d64-bf94-977b6fbbe713
SPL ID
45bbae71-dfa5-c0eb-e063-6394a90a343f
Version
1
Effective date
2025-12-12
Source export date
2026-08-01
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/63703fa640102c69d41ceeb8d73f46d0a0be448587814b2aeca60b43bed7e054/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:39:13
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 Do not use for treatment of diaper rash in eyes for feminine itching Stop use and ask a doctor if condition worsens or lasts more than 7 days, or clears up and occurs again within a few days you begin use of any other hydrocortisone product bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.