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: ANTI-PRURITIC
Manufacturer: Cardinal Health
Product type: HUMAN OTC DRUG
SPL set ID: 8b3af210-3097-8c10-e053-2a95a90a86f1
SPL ID: 44710f88-baec-2420-e063-6394a90aa6bc
Version: 9
Effective date: 2025-11-25
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:14:48

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		ANTI-PRURITIC	openfda.generic_name
manufacturer name		Cardinal Health	openfda.manufacturer_name
ndc	package	70000-0485-1	openfda.package_ndc
ndc	product	70000-0485	openfda.product_ndc
ndc11	package	70000048501	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		44710f88-baec-2420-e063-6394a90aa6bc	id
spl set id		8b3af210-3097-8c10-e053-2a95a90a86f1	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 If pregnant or breast-feeding, ask a health professional before use. Do not use in the eyes for diaper rash for external genital or feminine itching if you have a vaginal discharge more than the recommended daily dosage unless directed by a doctor this product in the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if condition worsens or if symptoms persist more than 7 days or clear up and occur again within a few days. Do not continue to use this or any other hydrocortisone product for longer than 7 days. bleeding occurs near anus when used for anal itching If swallowed, get medical help or contact a Poison Control Center (1-888-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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