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: Hydrocortisone
Generic name: HYDROCORTISONE
Manufacturer: Mericon Industries
Product type: HUMAN OTC DRUG
SPL set ID: 8f351b04-8f6d-4353-9100-13a8a80d656a
SPL ID: 4d3f087b-6bc1-f6b1-e063-6394a90a9047
Version: 3
Effective date: 2026-03-17
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 02:28:20

Harmonized routes table
Harmonized routes
TOPICAL

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Hydrocortisone	openfda.brand_name
generic name		HYDROCORTISONE	openfda.generic_name
manufacturer name		Mericon Industries	openfda.manufacturer_name
ndc	package	0394-0859-32	openfda.package_ndc
ndc	product	0394-0859	openfda.product_ndc
ndc11	package	00394085932	derived:openfda.package_ndc
rxcui		103403	openfda.rxcui
spl id		4d3f087b-6bc1-f6b1-e063-6394a90a9047	id
spl set id		8f351b04-8f6d-4353-9100-13a8a80d656a	set_id
unii		WI4X0X7BPJ	openfda.unii

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 Stop using this product and ask a doctor 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 Keep this and all drugs out of the reach of children

Reported adverse events (FAERS/openFDA)#

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