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 SPRAY
Manufacturer: FSA Store Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 3ce24b87-55ac-0bbd-e063-6294a90ab582
SPL ID: 3ce24e45-ca33-d85d-e063-6294a90af326
Version: 1
Effective date: 2025-08-19
Source export date: 2026-09-28
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:34:04

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 SPRAY	openfda.generic_name
manufacturer name		FSA Store Inc.	openfda.manufacturer_name
ndc	package	81522-914-01	openfda.package_ndc
ndc	product	81522-914	openfda.product_ndc
ndc11	package	81522091401	derived:openfda.package_ndc
rxcui		317564	openfda.rxcui
spl id		3ce24e45-ca33-d85d-e063-6294a90af326	id
spl set id		3ce24b87-55ac-0bbd-e063-6294a90ab582	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. Flammable: Keep away from fire or flame. Do not use for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with the eyes Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have consulted a doctor Keep out of the 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.