sunmark 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
sunmark Hydrocortisone
Generic name
HYDROCORTISONE
Manufacturer
Strategic Sourcing Services LLC
Product type
HUMAN OTC DRUG
SPL set ID
210079e9-3d2f-4489-b468-b96b145034ed
SPL ID
395c6919-b999-dbae-e063-6294a90af187
Version
4
Effective date
2025-07-07
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:56:38
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 Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 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.