Hydrocortisone Acetate

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 Acetate
Generic name: HYDROCORTISONE ACETATE
Manufacturer: QUAGEN PHARMACEUTICALS LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 60dce400-1138-4781-b621-1774c0dbb64a
SPL ID: f7679c3f-8095-41b8-8f9b-5e1f10b482b6
Version: 2
Effective date: 2023-05-17
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 05:15:11

Harmonized routes table
Harmonized routes
RECTAL

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Hydrocortisone Acetate	openfda.brand_name
generic name		HYDROCORTISONE ACETATE	openfda.generic_name
manufacturer name		QUAGEN PHARMACEUTICALS LLC	openfda.manufacturer_name
ndc	package	70752-169-23	openfda.package_ndc
ndc	package	70752-169-02	openfda.package_ndc
ndc	product	70752-169	openfda.product_ndc
ndc11	package	70752016902	derived:openfda.package_ndc
ndc11	package	70752016923	derived:openfda.package_ndc
rxcui		1291082	openfda.rxcui
spl id		f7679c3f-8095-41b8-8f9b-5e1f10b482b6	id
spl set id		60dce400-1138-4781-b621-1774c0dbb64a	set_id
unii		3X7931PO74	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 have been reported with hydrocortisone acetate suppositories; burning, itching, irritation, dryness, folliculitis, hypopigmentation, allergic contact dermatitis, secondary infection. To report an adverse event, please contact Quagen Pharmaceuticals LLC. at 1-888-344-9603, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reported adverse events (FAERS/openFDA)#

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