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 1%
Manufacturer: Weeks & Leo Co., Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 0c5325e3-4796-856c-e063-6394a90a1f90
SPL ID: 0c5325e3-4797-856c-e063-6394a90a1f90
Version: 1
Effective date: 2023-12-12
Source export date: 2026-10-12
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:55:07

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 1%	openfda.generic_name
manufacturer name		Weeks & Leo Co., Inc.	openfda.manufacturer_name
ndc	package	11383-268-02	openfda.package_ndc
ndc	package	11383-268-01	openfda.package_ndc
ndc	product	11383-268	openfda.product_ndc
ndc11	package	11383026801	derived:openfda.package_ndc
ndc11	package	11383026802	derived:openfda.package_ndc
rxcui		203105	openfda.rxcui
spl id		0c5325e3-4797-856c-e063-6394a90a1f90	id
spl set id		0c5325e3-4796-856c-e063-6394a90a1f90	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. Ask a doctor. for external genital itching if you have a vaginal discharge. Ask a doctor. for external anal itching if rectal bleeding occurs. Consult a doctor promptly. When using this product do not get in the eyes for external anal itching, do not use more than directed unless told to do so by a doctor do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product. 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.