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: Acme United Corporation
Product type: HUMAN OTC DRUG
SPL set ID: fabcaa3b-d189-bd29-e053-6294a90ae86b
SPL ID: 26bc4721-ef08-2542-e063-6394a90a5642
Version: 2
Effective date: 2024-11-12
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:41:06

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 · 23 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		Acme United Corporation	openfda.manufacturer_name
ndc	package	0924-1133-06	openfda.package_ndc
ndc	package	0924-1133-02	openfda.package_ndc
ndc	package	0924-1133-00	openfda.package_ndc
ndc	package	0924-1133-04	openfda.package_ndc
ndc	package	0924-1133-05	openfda.package_ndc
ndc	package	0924-1133-01	openfda.package_ndc
ndc	package	0924-1133-03	openfda.package_ndc
ndc	product	0924-1133	openfda.product_ndc
ndc11	package	00924113303	derived:openfda.package_ndc
ndc11	package	00924113304	derived:openfda.package_ndc
ndc11	package	00924113300	derived:openfda.package_ndc
ndc11	package	00924113302	derived:openfda.package_ndc
ndc11	package	00924113305	derived:openfda.package_ndc
ndc11	package	00924113301	derived:openfda.package_ndc
ndc11	package	00924113306	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		26bc4721-ef08-2542-e063-6394a90a5642	id
spl set id		fabcaa3b-d189-bd29-e053-6294a90ae86b	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 in eyes for diaper rash Stop use and ask a doctor if ▪ condition worsens or lasts for more than 7 days symptoms clear up and occur again within a few days ▪ you begin using other hydrocortisone products KEEP OUT OF REACH OF CHILDREN. If swallowed, contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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