FDA.reportPublic FDA data

WATER

Manufacturer
Uriel Pharmacy, Inc
Effective date
2025-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:31:32

Label at a glance#

ProductOlibanum Belladonna comp.
Active ingredientONOPORDUM ACANTHIUM FLOWER, MYRRH, FRANKINCENSE, HYOSCYAMUS NIGER LEAF, ATROPA BELLADONNA, PRIMULA VERIS FLOWER, GOLD
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 Ingredient: 100gm contains: 2.5gm Onopordon (Cotton thistle) 1X, 2.5gm Primula (Cowslip) 1X; Hyoscyamus (Henbane) 3X, Myrrha (Myrrh resin) 6X, Atropa belladonna e rad. (Nightshade) 10X, Olibanum (Frankincense) 12X, Aurum met. (Metallic gold) 30X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled water, 20% Organic cane alcohol, Lactose

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

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. Contains traces of lactose. 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

Olibanum Belladonna comp. LiquidOlibanum Belladonna comp. Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-7213-3Olibanum Belladonna comp.60 mL in 1 BOTTLE, DROPPERLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-7213OLIBANUM BELLADONNA COMP. LIQUID [URIEL PHARMACY, INC]1Current NDC, 1 package rows20250125_2c778131-9962-879a-e063-6394a90a56bb.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
48951-721348951-7213-3

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
ONOPORDUM ACANTHIUM FLOWERAP97AUF88EACTIB
MYRRHJC71GJ1F3LACTIB
FRANKINCENSER9XLF1R1WMACTIB
ALCOHOL3K9958V90MIACT
HYOSCYAMUS NIGER LEAF32IT7G8BAWACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
LACTOSEJ2B2A4N98GIACT
PRIMULA VERIS FLOWERW5BET37294ACTIB
GOLD79Y1949PYOACTIB

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
Olibanum Belladonna comp.OLIBANUM BELLADONNA COMP.Uriel Pharmacy, Inc2c778131-9962-879a-e063-6394a90a56bb2025-01-24WarningsExact identifier
ndc (package): 48951-7213-3
ndc (product): 48951-7213
ndc11 (package): 48951721303
spl id: 2c778131-9963-879a-e063-6394a90a56bb
spl set id: 2c778131-9962-879a-e063-6394a90a56bb

Reported adverse events (FAERS/openFDA)#

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