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: Sportpharm LLC
Product type: HUMAN OTC DRUG
SPL set ID: 9578b39e-3df7-4d75-abd7-f1d5524545e5
SPL ID: 4b8aeec1-8585-b6f7-e063-6394a90a3dae
Version: 1
Effective date: 2026-02-23
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:27:08

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 · 13 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		Sportpharm LLC	openfda.manufacturer_name
ndc	package	85766-166-25	openfda.package_ndc
ndc	package	85766-166-10	openfda.package_ndc
ndc	product	85766-166	openfda.product_ndc
ndc11	package	85766016625	derived:openfda.package_ndc
ndc11	package	85766016610	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		4b8aeec1-8585-b6f7-e063-6394a90a3dae	id
spl set id		9578b39e-3df7-4d75-abd7-f1d5524545e5	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 Do not use for the treatment of diaper rash with anyother Hydrocortisone product unless you have consulted adoctor if you have vaginal discharge, consulkt a doctor Stop use and ask a doctor if condition worsens or lasts more than 7 days, or clears and occurs again within a few days you begin use of any other Hydrocortisone product unless you have consulted a doctor bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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