FDA.reportPublic FDA data

87267-011-01 DRMITSUI MEDICAL HAEMORRHOID GEL

Manufacturer
YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED
Effective date
2026-05-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:56:39

Label at a glance#

ProductDRMITSUI MEDICAL HAEMORRHOID
Active ingredientWITCH HAZEL, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCI 0.25% ,

Witch hazel 50%.

OTC - PURPOSE SECTION

ANAL DISTENDING PAIN.

MUCOSAL CONGESTION.

PROLAPSE OF HAEMORRHOIDS

INTERNAL & MIXED HAEMORRHOIDS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of reach of children

WARNINGS SECTION

WARNINGS

For external use only.

DOSAGE & ADMINISTRATION SECTION

Apply externally to the affectedarea up to 4 times daily, especiallyat night, in the morning or aftereach bowel movement

INDICATIONS & USAGE SECTION

Swith an appropriate cleansing wipe.Gently dry by patting or blotting witha tissue or a soft cloth before applyinggel. When first opening the tube,puncture foil seal with topend of cap..Apply externally to the affectedarea up to 4 times daily, especiallyat night, in the morning or aftereach bowel movement..Childrenunder 12 years of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Carbomer, Glycerol, Hydroxybenzoate ethyl ester, Triethanolamine, Purified water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
249465phenylephrine HCl 0.25 % / witch hazel 50 % Rectal GelPSN1
249465phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal GelSCD1
249465phenylephrine 0.25 % / witch hazel 50 % Rectal GelSY1

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
87267-011-01DRMITSUI MEDICAL HAEMORRHOID5 in 1 BOXGEL51
87267-011-01DRMITSUI MEDICAL HAEMORRHOID5 g in 1 TUBEGEL51

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87267-01187267-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCEROL, IODINATED8C0LU36AR9IACT
WITCH HAZEL101I4J0U34ACTIB
ETHYLPARABEN14255EXE39IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
WATER059QF0KO0RIACT
CARBOMER0A5MM307FCIACT
TRIETHANOLAMINE9O3K93S3TKIACT

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
DRMITSUI MEDICAL HAEMORRHOIDPHENYLEPHRINE HCI WITCH HAZELYIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED51720221-893b-cade-e063-6394a90adaec2026-05-10WarningsExact identifier
ndc (package): 87267-011-01
ndc (product): 87267-011
ndc11 (package): 87267001101
spl id: 51720221-893c-cade-e063-6394a90adaec
spl set id: 51720221-893b-cade-e063-6394a90adaec

Reported adverse events (FAERS/openFDA)#

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