PREPARATION H

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: PREPARATION H
Generic name: PHENYLEPHRINE HYDROCHLORIDE
Manufacturer: Haleon US Holdings LLC
Product type: HUMAN OTC DRUG
SPL set ID: 96d2e0e7-2de0-4660-9ffd-9edb2ad224d8
SPL ID: 331041bf-cde7-dceb-e063-6394a90a65e0
Version: 4
Effective date: 2025-04-18
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:54:06

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
application number		M015	openfda.application_number
brand name		PREPARATION H	openfda.brand_name
generic name		PHENYLEPHRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Haleon US Holdings LLC	openfda.manufacturer_name
ndc	package	0573-1378-00	openfda.package_ndc
ndc	package	0573-1378-06	openfda.package_ndc
ndc	package	0573-1378-01	openfda.package_ndc
ndc	product	0573-1378	openfda.product_ndc
ndc11	package	00573137800	derived:openfda.package_ndc
ndc11	package	00573137806	derived:openfda.package_ndc
ndc11	package	00573137801	derived:openfda.package_ndc
spl id		331041bf-cde7-dceb-e063-6394a90a65e0	id
spl set id		96d2e0e7-2de0-4660-9ffd-9edb2ad224d8	set_id
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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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