FDA.reportPublic FDA data

UlcerPlex

Manufacturer
King Bio Inc.
Effective date
2016-03-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:07:33

Label at a glance#

ProductUlcerPlex
Active ingredientSEMECARPUS ANACARDIUM JUICE, SILVER NITRATE, ARSENIC TRIOXIDE, ATROPINE, ACTIVATED CHARCOAL, GERANIUM MACULATUM ROOT, POTASSIUM DICHROMATE, ORNITHOGALUM UMBELLATUM, URANYL NITRATE HEXAHYDRATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: ​ Anacardium orientale, Argentum nitricum, Arsenicum album, Atropinum, Carbo vegetabilis, Geranium maculatum, Kali bichromicum, Ornithogalum umbellatum, Uranium nitricum. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

INDICATIONS & USAGE SECTION

Uses for temporary relief of minor symptoms of: burning, gnawing, or radiating pains in the stomach area, nausea, poor digestion.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS SECTION

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up: 3 sprays 3 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if safety seal is intact.

OTC - PURPOSE SECTION

Uses ​for temporary relief of minor symptoms of:

  • burning, gnawing, or radiating pains in the stomach area
  • nausea
  • poor digestion

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-5074-22020-01-31C16284748780-19d75b9d0-5f1d-f424-e053-dadaa90a57ceUlcerPlex™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-5074-2UlcerPlex59 mL in 1 BOTTLE, SPRAYLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-5074ULCERPLEX (ANACARDIUM ORIENTALE, ARGENTUM NITRICUM, ARSENICUM ALBUM, ATROPINUM, CARBO VEGETABILIS, GERANIUM MACULATUM, KALI BICHROMICUM, ORNITHOGALUM UMBELLATUM URANIUM NITRICUM) LIQUID [KING BIO INC.]2Legacy NDC, 1 package rows20160322_8d94bc9c-656b-4f5f-a30b-cc37db6f2b18.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-507457955-5074-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SEMECARPUS ANACARDIUM JUICEY0F0BU8RDUACTIB
SILVER NITRATE95IT3W8JZEACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPINE7C0697DR9IACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
GERANIUM MACULATUM ROOT93IXI5B6OJACTIB
POTASSIUM DICHROMATET4423S18FMACTIB
ORNITHOGALUM UMBELLATUM9NS3M2Y78SACTIB
URANYL NITRATE HEXAHYDRATE3V057702FYACTIB
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
33dec8db-5faa-417d-96bc-36006e220b588d94bc9c-656b-4f5f-a30b-cc37db6f2b182016-03-22WarningsExact identifier
spl id: 33dec8db-5faa-417d-96bc-36006e220b58
spl set id: 8d94bc9c-656b-4f5f-a30b-cc37db6f2b18

Reported adverse events (FAERS/openFDA)#

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