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: Westminster Pharmaceuticals, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 3a29006f-9124-45e7-84a2-48f08bbb5f9c
SPL ID: 27e6ec88-81d3-47d2-94d0-7fe6e2265237
Version: 10
Effective date: 2024-12-04
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:32:03

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 · 16 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		Westminster Pharmaceuticals, LLC	openfda.manufacturer_name
ndc	package	69367-260-12	openfda.package_ndc
ndc	package	69367-243-24	openfda.package_ndc
ndc	package	69367-243-12	openfda.package_ndc
ndc	product	69367-260	openfda.product_ndc
ndc	product	69367-243	openfda.product_ndc
ndc11	package	69367026012	derived:openfda.package_ndc
ndc11	package	69367024312	derived:openfda.package_ndc
ndc11	package	69367024324	derived:openfda.package_ndc
rxcui		1291085	openfda.rxcui
rxcui		1291082	openfda.rxcui
spl id		27e6ec88-81d3-47d2-94d0-7fe6e2265237	id
spl set id		3a29006f-9124-45e7-84a2-48f08bbb5f9c	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 Westminster Pharmaceuticals, LLC at 1-844-221-7294.

Reported adverse events (FAERS/openFDA)#

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