FDA.reportPublic FDA data

PRIMULA VERIS FLOWER EXTRACT

Manufacturer
Uriel Pharmacy, Inc.
Effective date
2024-11-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:29:05

Label at a glance#

ProductOnopordon comp.
Active ingredientPRIMULA VERIS FLOWER EXTRACT, ONOPORDUM ACANTHIUM 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, 30% Organic cane alcohol

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.

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. 60 ml LiquidOnopordon comp. 60 ml Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-7211-3Onopordon comp.60 mL in 1 BOTTLE, DROPPERLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-7211ONOPORDON COMP. LIQUID [URIEL PHARMACY, INC.]11 package rows20241127_27bffa28-c5f9-7f6d-e063-6394a90ab472.zip

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
48951-721148951-7211-3

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
PRIMULA VERIS FLOWER EXTRACTW5BET37294ACTIB
ONOPORDUM ACANTHIUM FLOWERAP97AUF88EACTIB
HYOSCYAMUS NIGER LEAF32IT7G8BAWACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
27bffa28-c5fa-7f6d-e063-6394a90ab47227bffa28-c5f9-7f6d-e063-6394a90ab4722024-11-25WarningsExact identifier
spl id: 27bffa28-c5fa-7f6d-e063-6394a90ab472
spl set id: 27bffa28-c5f9-7f6d-e063-6394a90ab472

Reported adverse events (FAERS/openFDA)#

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