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: 40fde50a-3cc0-4286-9b33-8f3912254c33
SPL ID: 463eea99-6d71-9757-e063-6294a90a668f
Version: 2
Effective date: 2025-12-18
Source export date: 2026-11-06
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/10387d7618367cd955339e75d48af3d11f99f789153db05c529d9fad6eccc645/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:15:52

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	0573-2919-48	openfda.package_ndc
ndc	package	0573-2919-24	openfda.package_ndc
ndc	package	0573-2919-12	openfda.package_ndc
ndc	product	0573-2919	openfda.product_ndc
ndc11	package	00573291948	derived:openfda.package_ndc
ndc11	package	00573291912	derived:openfda.package_ndc
ndc11	package	00573291924	derived:openfda.package_ndc
spl id		463eea99-6d71-9757-e063-6294a90a668f	id
spl set id		40fde50a-3cc0-4286-9b33-8f3912254c33	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.