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: Proficient Rx LP
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: d50240db-f630-4008-a272-55ba5c991304
SPL ID: 8335b16b-0981-4efd-88f7-c3999bbaef04
Version: 6
Effective date: 2022-07-01
Source export date: 2026-10-12
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:43:38

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	ANDA	089682	derived:openfda.application_number
application number		ANDA089682	openfda.application_number
brand name		Hydrocortisone	openfda.brand_name
generic name		HYDROCORTISONE	openfda.generic_name
manufacturer name		Proficient Rx LP	openfda.manufacturer_name
ndc	package	63187-480-20	openfda.package_ndc
ndc	package	63187-480-30	openfda.package_ndc
ndc	product	63187-480	openfda.product_ndc
ndc11	package	63187048020	derived:openfda.package_ndc
ndc11	package	63187048030	derived:openfda.package_ndc
rxcui		310891	openfda.rxcui
spl id		8335b16b-0981-4efd-88f7-c3999bbaef04	id
spl set id		d50240db-f630-4008-a272-55ba5c991304	set_id
unii		WI4X0X7BPJ	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Reported adverse events (FAERS/openFDA)#

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