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: AvPAK
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: d13b0bea-4c7b-4ee4-aab1-aca8cdcea7fd
SPL ID: 47e557c1-ab4b-0c31-e063-6394a90adad8
Version: 8
Effective date: 2026-01-08
Source export date: 2026-10-12
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/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:27:43

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 · 14 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		AvPAK	openfda.manufacturer_name
ndc	package	50268-411-01	openfda.package_ndc
ndc	package	50268-411-24	openfda.package_ndc
ndc	package	50268-411-12	openfda.package_ndc
ndc	product	50268-411	openfda.product_ndc
ndc11	package	50268041124	derived:openfda.package_ndc
ndc11	package	50268041112	derived:openfda.package_ndc
ndc11	package	50268041101	derived:openfda.package_ndc
rxcui		1291082	openfda.rxcui
spl id		47e557c1-ab4b-0c31-e063-6394a90adad8	id
spl set id		d13b0bea-4c7b-4ee4-aab1-aca8cdcea7fd	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 SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or email drugsafety@avkare.com.

Reported adverse events (FAERS/openFDA)#

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