Home FDA labels d38b4993-22b9-49e2-b004-52f4504310fe FDA label d38b4993-22b9-49e2-b004-52f4504310fe 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)
SPL set ID 290de58f-fb3f-4120-aea7-4561cdf60fee
SPL ID d38b4993-22b9-49e2-b004-52f4504310fe
Version 3
Effective date 2024-12-30
Source export date 2026-10-12
Source partition 10
Source file https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:30:54 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions Adverse Reactions The following local adverse reactions have been reported with hydrocortisone suppositories: Burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergy contact dermatitis, secondary infection. To report suspected adverse reactions, contact Vitruvias Therapeutics at 1–844–451–5944 or FDA @ 1–800–FDA–1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.