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 ACETATE
Manufacturer: Walgreen Company
Product type: HUMAN OTC DRUG
SPL set ID: bff322f1-59c3-41e0-8685-fcfe52bf4b42
SPL ID: 39943e05-248b-fffe-e063-6394a90a45a3
Version: 3
Effective date: 2025-07-10
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:38:52

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 ACETATE	openfda.generic_name
manufacturer name		Walgreen Company	openfda.manufacturer_name
ndc	package	0363-0972-02	openfda.package_ndc
ndc	product	0363-0972	openfda.product_ndc
ndc11	package	00363097202	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		39943e05-248b-fffe-e063-6394a90a45a3	id
spl set id		bff322f1-59c3-41e0-8685-fcfe52bf4b42	set_id
unii		3X7931PO74	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 the eyes by putting this product into the rectum by using fingers or any mechanical device or applicator Ask a doctor before use if you have a vaginal discharge rectal bleeding diaper rash When using this product consult a doctor before exceeding recommended dosage Stop use and ask a doctor if condition gets worse condition persists for more than 7 days condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor. 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.