FDA.reportPublic FDA data

Hemorrhoidal

Manufacturer
GRAXCELL PHARMACEUTICAL, LLC | GRAXCELL PHARMACEUTICAL, LLC. | Graxcell Pharmaceutical llc
Effective date
2025-12-25
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:28:42

Label at a glance#

ProductHemorrhoidal
Active ingredientCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

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 doctor

Storage and handling

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

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

Vasoconstructor

Uses

INDICATIONS & USAGE SECTION

  • temporarily shrinks hemorrhoidal tissues
  • 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
  • high blood pressure
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

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 Adults

DOSAGE & ADMINISTRATION SECTION

  • 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 doctor

Other Information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

methylparaben, propylparaben, starch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1

Label 2Label 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN8
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD8
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY8

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70795-1021-22025-12-26C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-42025-12-26C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-22024-01-30C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-42024-01-30C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-22020-11-16C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-42020-11-16C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-22020-01-31C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021
70795-1021-42020-01-31C16284748780-19d75b9d0-5f62-f424-e053-dadaa90a57ceGRAXCELL PHARMACEUTICAL - HEMORRHOIDAL SUPPOSITORIES, 70795-1021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70795-1021-2Hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY18
70795-1021-2Hemorrhoidal12 in 1 BOXSUPPOSITORY128
70795-1021-4Hemorrhoidal1 in 1 BLISTER PACKSUPPOSITORY18
70795-1021-4Hemorrhoidal24 in 1 BOXSUPPOSITORY248

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70795-1021-2EA - Each70795-102128ec95ae-d4d6-4b36-b307-9a586286b34212017-10-13
70795-1021-4EA - Each70795-10213cbf5c99-ff79-4627-b851-2f55ceb6deee12017-10-13

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
70795-102170795-1021-2, 70795-1021-4

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
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
STARCH, CORNO8232NY3SJIACT
COCOA BUTTER512OYT1CRRACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDEGRAXCELL PHARMACEUTICAL, LLC5162baee-0d63-494e-8046-459437b853482025-12-25WarningsExact identifier
ndc (package): 70795-1021-2
ndc (package): 70795-1021-4
ndc (product): 70795-1021
ndc11 (package): 70795102102
ndc11 (package): 70795102104
spl id: 46d4393d-b3e0-9755-e063-6294a90aced8
spl set id: 5162baee-0d63-494e-8046-459437b85348

Reported adverse events (FAERS/openFDA)#

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