FDA.reportPublic FDA data

Hydrocortisone Acetate

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 Acetate
Generic name
HYDROCORTISONE ACETATE
Manufacturer
AARNA USA INC.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
4f9709ed-4818-3d3b-e063-6394a90a0d04
SPL ID
4f970a04-dc6b-ef78-e063-6394a90aef6b
Version
1
Effective date
2026-04-16
Source export date
2026-08-08
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/c371bcf53af83126908f941c4bb6f83aeaa6e2ef3749f9f7be6c7a3681e3b333/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:22:56
Harmonized routes table
Harmonized routes
RECTAL

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS The following local adverse reactions have been reported with hydrocortisone acetate suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection. To report an adverse event, please contact AARNA USA INC at 1-877-225-6999.