0.25 % PHENYLEPHRINE HCl 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: 0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL
Generic name: MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer: Universal Distribution Center LLC
Product type: HUMAN OTC DRUG
SPL set ID: 90844919-f16a-4390-9dca-b0405b501445
SPL ID: 22df9c1b-c87e-46e8-a9f5-6a03e7549253
Version: 1
Effective date: 2026-01-08
Source export date: 2026-10-12
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/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:13:14

Harmonized routes table
Harmonized routes
TOPICAL

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
application number		M015	openfda.application_number
brand name		0.25 % PHENYLEPHRINE HCl HEMORRHOIDAL	openfda.brand_name
generic name		MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Universal Distribution Center LLC	openfda.manufacturer_name
ndc	package	52000-438-02	openfda.package_ndc
ndc	product	52000-438	openfda.product_ndc
ndc11	package	52000043802	derived:openfda.package_ndc
rxcui		1372298	openfda.rxcui
spl id		22df9c1b-c87e-46e8-a9f5-6a03e7549253	id
spl set id		90844919-f16a-4390-9dca-b0405b501445	set_id
unii		4T6H12BN9U	openfda.unii
unii		T5L8T28FGP	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 external 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 • introduction of applicator into the rectum causes additional pain If pregnant or breast-feeding , ask a healthcare 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.