FDA.reportPublic FDA data

Onopordon comp. 1% Special Order

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-05-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:55:53

Label at a glance#

ProductOnopordon comp. 1% Special Order
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.

DOSAGE & ADMINISTRATION SECTION

Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: 100 gm contains: 0.5 gm Onopordon e flor. 1X, 0.5 gm Primula e flor. 1X; Hyoscyamus ex herba 2X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OnopordonComp1SpecialOrderAmpulesOnopordonComp1SpecialOrderAmpules

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
48951-711848951-7118-1

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
SODIUM CHLORIDE451W47IQ8XIACT
ONOPORDUM ACANTHIUM FLOWERAP97AUF88EACTIB
PRIMULA VERIS FLOWERW5BET37294ACTIB
HYOSCYAMUS NIGER LEAF32IT7G8BAWACTIB
WATER059QF0KO0RIACT

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
b5944ec9-b3d0-7623-e053-2a95a90ac9de6d0df6de-212e-5090-e053-2991aa0ad50d2020-12-03WarningsExact identifier
spl set id: 6d0df6de-212e-5090-e053-2991aa0ad50d

Reported adverse events (FAERS/openFDA)#

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