Leader Hemorrhoidal

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: Leader Hemorrhoidal
Generic name: COCOA BUTTER, PHENYLEPHRINE HCL
Manufacturer: Cardinal Health 110, LLC. dba Leader
Product type: HUMAN OTC DRUG
SPL set ID: c4814524-0f4c-4351-a431-5b4b6431fd28
SPL ID: 81b067a6-e260-4be0-b62b-da0ce6cb0640
Version: 4
Effective date: 2024-10-23
Source export date: 2026-10-27
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/2026-10-27/977776a6cc37ec1c77259da8a93ae161850a3aa120341096e5a03428b84d016b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:57:03

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M015	openfda.application_number
brand name		Leader Hemorrhoidal	openfda.brand_name
generic name		COCOA BUTTER, PHENYLEPHRINE HCL	openfda.generic_name
manufacturer name		Cardinal Health 110, LLC. dba Leader	openfda.manufacturer_name
ndc	package	70000-0223-1	openfda.package_ndc
ndc	product	70000-0223	openfda.product_ndc
ndc11	package	70000022301	derived:openfda.package_ndc
rxcui		1438497	openfda.rxcui
spl id		81b067a6-e260-4be0-b62b-da0ce6cb0640	id
spl set id		c4814524-0f4c-4351-a431-5b4b6431fd28	set_id
unii		512OYT1CRR	openfda.unii
unii		04JA59TNSJ	openfda.unii

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For rectal use only Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. When using this product do not exceed the recommended daily dosage unless directed by a doctor Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days If pregnant or breast feeding, ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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