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: Nantong Health & Beyond Hygienic Products Inc.
Product type: HUMAN OTC DRUG
SPL set ID: fbbbcc67-b46d-d41a-e053-6294a90aa55d
SPL ID: 1f390f4e-6459-89ef-e063-6294a90a33ed
Version: 3
Effective date: 2024-08-08
Source export date: 2026-10-27
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-27/2c7d3f7bcea1543046130e07dcbaf7eea5fb0ce23f7faa6458d1c6d80c3fa0c3/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:44:06

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 · 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		Nantong Health & Beyond Hygienic Products Inc.	openfda.manufacturer_name
ndc	package	43473-049-01	openfda.package_ndc
ndc	product	43473-049	openfda.product_ndc
ndc11	package	43473004901	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		1f390f4e-6459-89ef-e063-6294a90a33ed	id
spl set id		fbbbcc67-b46d-d41a-e053-6294a90aa55d	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. Do not use for the treatment of diaper rash. Consult a doctor. Do not use, consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor. Do not use if the packaging is broken 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.