FDA.reportPublic FDA data

Xyralid Hemorrhoidal

Manufacturer
Innovus Pharmaceuticals, Inc. | Unipack, Inc.
Effective date
2018-05-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:55:26

Label at a glance#

ProductXyralid Hemorrhoidal
Active ingredientCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

temporarily shrinks hemorrhoidal tissue temporarily relieves itching, burning, and discomfort associated with hemorrhoids aids in protecting irritated anorectal areas

Dosage and administration

-Adults:  when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.  Gently dry by patting or blotting with a toilet tissue or a soft cloth. -remove the wrapper before inserting into the rectum. -insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement. -Children under 12 years of age: consult a doctor

Storage and handling

Store at 20-25 o C (68-77 o F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Cocoa butter 88.50%...................................................................Protectant

Phenylephrine hydrochloride 0.26%..............................................Vasoconstrictor

Uses

OTC - PURPOSE SECTION

  • temporarily shrinks hemorrhoidal tissue
  • temporarily relieves itching, burning, and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas

Warnings

WARNINGS SECTION

For rectal use only

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

-heart disease    -high blood pressure

-thyroid disease   -diabetes

-difficulty in urination due to enlargement of the prostate gland

When using this product

INDICATIONS & USAGE SECTION

do not exceed the recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

bleeding occurs or condition worsens or does not improve within 7 days

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

-Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.  Gently dry by patting or blotting with a toilet tissue or a soft cloth.

-remove the wrapper before inserting into the rectum.

-insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement.

-Children under 12 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store at 20-25oC (68-77oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, methylparaben, propylparaben

Purpose

OTC - PURPOSE SECTION

Protectant

Vasoconstrictor

Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton LabelCarton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN1
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD1
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57483-410-12Xyralid Hemorrhoidal24 g in 1 BLISTER PACKSUPPOSITORY241
57483-410-13Xyralid Hemorrhoidal4 in 1 CARTONSUPPOSITORY41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57483-410XYRALID HEMORRHOIDAL (HEMORRHOIDAL SUPPOSITORIES) SUPPOSITORY [INNOVUS PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 2 package rows20180504_8a885822-42e7-44e0-82d6-fa967123866e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57483-41057483-410-12, 57483-410-13

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCOA BUTTER512OYT1CRRACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)461P5CJN6TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xyralid HemorrhoidalHEMORRHOIDAL SUPPOSITORIESInnovus Pharmaceuticals, Inc.8a885822-42e7-44e0-82d6-fa967123866e2018-05-03WarningsExact identifier
ndc (package): 57483-410-13
ndc (package): 57483-410-12
ndc (product): 57483-410
ndc11 (package): 57483041013
ndc11 (package): 57483041012
spl id: cd6eb255-a89d-40c5-90a0-13f907ab0ad5
spl set id: 8a885822-42e7-44e0-82d6-fa967123866e

Reported adverse events (FAERS/openFDA)#

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