Proctocort

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: Proctocort
Generic name: HYDROCORTISONE ACETATE
Manufacturer: Salix Pharmaceuticals, Inc
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: a2e1222a-ab91-4382-a210-7dfdd6de1407
SPL ID: 22516e69-93a6-2892-e063-6394a90ae27b
Version: 4
Effective date: 2024-09-17
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:52:24

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Proctocort	openfda.brand_name
generic name		HYDROCORTISONE ACETATE	openfda.generic_name
manufacturer name		Salix Pharmaceuticals, Inc	openfda.manufacturer_name
ndc	package	65649-511-12	openfda.package_ndc
ndc	package	65649-511-24	openfda.package_ndc
ndc	product	65649-511	openfda.product_ndc
ndc11	package	65649051124	derived:openfda.package_ndc
ndc11	package	65649051112	derived:openfda.package_ndc
rxcui		1291092	openfda.rxcui
rxcui		1291085	openfda.rxcui
spl id		22516e69-93a6-2892-e063-6394a90ae27b	id
spl set id		a2e1222a-ab91-4382-a210-7dfdd6de1407	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 Salix Pharmaceuticals at 1-800-321-4576 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.