FDA.reportPublic FDA data

Hemorrhoidal

Manufacturer
Pharmacy Value Alliance LLC | DSC Laboratories Inc.
Effective date
2025-10-24
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:40:21

Label at a glance#

ProductHemorrhoidal
Active ingredientCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily shrinks hemorrhoidal tissue gives temporary relief to the itching, burning and discomfort associated with hemorrhoids aids in protecting irritated anorectal areas

Dosage and administration

Adults detach one suppository from the strip. 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

Label contents#

Full prescribing information#

Active Ingredients (per suppository)

OTC - ACTIVE INGREDIENT SECTION

Cocoa butter 88.44%

Phenylephrine hydrochloride 0.25%

Purpose

OTC - PURPOSE SECTION

Protectant

Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

  • temporarily shrinks hemorrhoidal tissue
  • gives temporary relief to the 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

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
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland
  • high blood pressure
  • diabetes

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding or if condition worsens or does not improve within 7 days, consult a doctor promptly

If pregnant or breast-feeding,

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

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults

  • detach one suppository from the strip. 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

OTHER SAFETY INFORMATION

Store at room temperature or in a cool place but not over 80°F

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, methylparaben, propylparaben

Questions or comments?

OTC - QUESTIONS SECTION

1-800-492-5988

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The product package shown below represents a sample of that currently in use. Additional packaging may also be available.

Premier Value Hemorrhoidal Suppositories 12ct

Distributed by Pharmacy Value Alliance LLC

407 East Lancaster Avenue

Wayne, PA 19087

785PVHemSupp.jpg

Premier Value Hemorrhoidal SuppositoriesPremier Value Hemorrhoidal Suppositories

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130840986034190GTIN-13: 0840986034190
EAN-13: 0840986034190
GTIN-12: 840986034190
UPC-A: 840986034190
GTIN storage (14 digits): 00840986034190		785PVHemSupp.jpg

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
68016-322-12Hemorrhoidal6 in 1 BLISTER PACKSUPPOSITORY67
68016-322-12Hemorrhoidal2 in 1 CARTONSUPPOSITORY27
68016-322-24Hemorrhoidal6 in 1 BLISTER PACKSUPPOSITORY67
68016-322-24Hemorrhoidal4 in 1 CARTONSUPPOSITORY47

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
68016-32268016-322-12, 68016-322-24

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
STARCH, CORNO8232NY3SJIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
COCOA BUTTER512OYT1CRRACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-12-12full-release2026-06-01 00:43:23

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
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLPharmacy Value Alliance LLC903b77fc-02bf-73b6-e053-2a95a90ad4cc2025-10-24WarningsExact identifier
ndc (package): 68016-322-12
ndc (package): 68016-322-24
ndc (product): 68016-322
ndc11 (package): 68016032212
ndc11 (package): 68016032224
spl id: 41e9cf64-ae0f-4127-e063-6294a90ad186
spl set id: 903b77fc-02bf-73b6-e053-2a95a90ad4cc

Reported adverse events (FAERS/openFDA)#

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