FDA label 029524b2-5ac3-392f-e063-6394a90ac963

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: 8ed6b334-5e1d-1c53-e053-2a95a90aaa49
SPL ID: 029524b2-5ac3-392f-e063-6394a90ac963
Version: 6
Effective date: 2023-08-10
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:37:37

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.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		029524b2-5ac3-392f-e063-6394a90ac963	id
spl set id		8ed6b334-5e1d-1c53-e053-2a95a90aaa49	set_id

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 the treatment of diaper rash with any other Hydrocortisone product unless you have consulted a doctor if you have a vaginal discharge, consult a doctor When using this product avoid contact with eyes do not put this product into rectum by using fingers, mechanical device or applicator do not exceed recommended daily dosage unless directed by a doctor Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product rectal bleeding occurs

Reported adverse events (FAERS/openFDA)#

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