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: Amazon.com Services LLC
Product type: HUMAN OTC DRUG
SPL set ID: 5f87d7fb-f258-48b0-8b60-1055e22ebd71
SPL ID: de79bead-5238-41ab-b242-ff1509c1df3c
Version: 2
Effective date: 2026-08-25
Source export date: 2026-10-30
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/e1583c3c823c7746dc6fefae78ac97d01bb558f7b0936fc3b7d2e673d3319207/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:36:19

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	openfda.generic_name
manufacturer name		Amazon.com Services LLC	openfda.manufacturer_name
ndc	package	72288-469-25	openfda.package_ndc
ndc	package	72288-469-00	openfda.package_ndc
ndc	product	72288-469	openfda.product_ndc
ndc11	package	72288046925	derived:openfda.package_ndc
ndc11	package	72288046900	derived:openfda.package_ndc
rxcui		103403	openfda.rxcui
spl id		de79bead-5238-41ab-b242-ff1509c1df3c	id
spl set id		5f87d7fb-f258-48b0-8b60-1055e22ebd71	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. Consult a doctor. When using this product • avoid contact with eyes • do not use more than directed unless told to do so by a doctor Stop use and ask a doctor if • condition worsens, or if 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 asked a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

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