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: ANTIPRURITIC (ANTI-ITCH)
Manufacturer: Dynarex Corporation
Product type: HUMAN OTC DRUG
SPL set ID: 81dff9df-6f7e-49f0-e053-2a91aa0af7e7
SPL ID: 0fa32e68-a566-6d7e-e063-6394a90af08b
Version: 6
Effective date: 2024-01-23
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 05:37:59

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 · 25 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M032	openfda.application_number
brand name		Hydrocortisone	openfda.brand_name
generic name		ANTIPRURITIC (ANTI-ITCH)	openfda.generic_name
manufacturer name		Dynarex Corporation	openfda.manufacturer_name
ndc	package	67777-004-06	openfda.package_ndc
ndc	package	67777-004-08	openfda.package_ndc
ndc	package	67777-004-01	openfda.package_ndc
ndc	package	67777-004-03	openfda.package_ndc
ndc	package	67777-004-05	openfda.package_ndc
ndc	package	67777-004-04	openfda.package_ndc
ndc	package	67777-004-07	openfda.package_ndc
ndc	package	67777-004-02	openfda.package_ndc
ndc	product	67777-004	openfda.product_ndc
ndc11	package	67777000407	derived:openfda.package_ndc
ndc11	package	67777000404	derived:openfda.package_ndc
ndc11	package	67777000408	derived:openfda.package_ndc
ndc11	package	67777000402	derived:openfda.package_ndc
ndc11	package	67777000405	derived:openfda.package_ndc
ndc11	package	67777000403	derived:openfda.package_ndc
ndc11	package	67777000401	derived:openfda.package_ndc
ndc11	package	67777000406	derived:openfda.package_ndc
rxcui		106258	openfda.rxcui
spl id		0fa32e68-a566-6d7e-e063-6394a90af08b	id
spl set id		81dff9df-6f7e-49f0-e053-2a91aa0af7e7	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 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 for 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 due to anal itching Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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