FDA.reportPublic FDA data

WATER

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:28:57

Label at a glance#

ProductDrosera comp.
Active ingredientDROSERA ROTUNDIFOLIA, ATROPA BELLADONNA, QUILLAJA SAPONARIA BARK, PROTORTONIA CACTI, HELLEBORUS FOETIDUS ROOT, IPECAC, MEPHITIS MEPHITIS ANAL GLAND FLUID, VERATRUM ALBUM ROOT
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Drosera (Sundew) 3X, Atropa belladonna (Nightshade) 4X, China (Peruvian bark) 4X, Coccus cacti (Cochineal bug, female) 4X, Helleborus (Christmas rose) 4X, Ipecacuanha (Ipecac) 4X, Veratrum (White hellebore) 4X, Mephitis (Secretion from the rectal gland of skunk) 4X.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled water, 20% Organic cane alcohol

Prepared using rhythmical processes

OTC - PURPOSE SECTION

Use: Temporary relief of cough.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditons or if conditons worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drosera comp. LiquidDrosera comp. Liquid

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-4184-3Drosera comp.60 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-4184DROSERA COMP. LIQUID [URIEL PHARMACY INC.]21 package rows20241121_12daa0aa-73ca-93ae-e063-6394a90a172d.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-418448951-4184-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
DROSERA ROTUNDIFOLIAQR44N9XPJQACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
QUILLAJA SAPONARIA BARK8N0K3807ZWACTIB
PROTORTONIA CACTILZB7TFX1LTACTIB
HELLEBORUS FOETIDUS ROOT332Y7EES96ACTIB
IPECAC62I3C8233LACTIB
MEPHITIS MEPHITIS ANAL GLAND FLUID3BN57UN4USACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB

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
274a50ea-557d-f833-e063-6394a90a185212daa0aa-73ca-93ae-e063-6394a90a172d2024-11-19WarningsExact identifier
spl id: 274a50ea-557d-f833-e063-6394a90a1852
spl set id: 12daa0aa-73ca-93ae-e063-6394a90a172d

Reported adverse events (FAERS/openFDA)#

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