FDA.reportPublic FDA data

WATER

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:29:03

Label at a glance#

ProductOnopordon comp.
Active ingredientONOPORDUM ACANTHIUM FLOWER, PRIMULA VERIS FLOWER, HYOSCYAMUS NIGER LEAF
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: 100gm contains: 2.5gm Onopordon (Cotton thistle) 1X, 2.5gm Primula (Cowslip) 1X; Hyoscyamus (Henbane) 3X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled water, Propolis

Prepared using rhythmical processes

OTC - PURPOSE SECTION

Use: Promotes healthy circulatory support.

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 conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

REFRIGERATE AFTER OPENING.
BEST WHEN USED WITHIN 30 DAYS OF OPENING.

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

Onopordon comp. LiquidOnopordon comp. Liquid

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48951-7089-32026-01-29C16284748780-149896155-aa92-586f-e063-e6dba90add90Onopordon comp.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-7089-3Onopordon comp.60 mL in 1 BOTTLE, DROPPERLIQUID605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-7089ONOPORDON COMP. LIQUID [URIEL PHARMACY INC.]5Legacy NDC, 1 package rows20241123_6f61e98d-fd67-42d7-9826-45f35aa21bf5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYOSCYAMUS NIGER LEAFACTIVE INGREDIENT32IT7G8BAW1
ONOPORDUM ACANTHIUM FLOWERACTIVE INGREDIENTAP97AUF88E1
PRIMULA VERIS FLOWERACTIVE INGREDIENTW5BET372941
HYOSCYAMUS NIGER LEAFACTIVE MOIETY32IT7G8BAW1
ONOPORDUM ACANTHIUM FLOWERACTIVE MOIETYAP97AUF88E1
PRIMULA VERIS FLOWERACTIVE MOIETYW5BET372941
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOF1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-708948951-7089-3

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
WATER059QF0KO0RIACT
PROPOLIS WAX6Y8XYV2NOFIACT
ONOPORDUM ACANTHIUM FLOWERAP97AUF88EACTIB
PRIMULA VERIS FLOWERW5BET37294ACTIB
HYOSCYAMUS NIGER LEAF32IT7G8BAWACTIB

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
2770bcd5-3ce0-e261-e063-6294a90a10306f61e98d-fd67-42d7-9826-45f35aa21bf52024-11-21WarningsExact identifier
spl id: 2770bcd5-3ce0-e261-e063-6294a90a1030
spl set id: 6f61e98d-fd67-42d7-9826-45f35aa21bf5

Reported adverse events (FAERS/openFDA)#

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