FDA.reportPublic FDA data

LACTOSE

Manufacturer
Uriel Pharmacy, Inc
Effective date
2025-02-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:31:50

Label at a glance#

ProductOlibanum comp.
Active ingredientOLIBANUM, MYRRH, 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: Myrrha (Myrrh resin) 6X, 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 comp. LiquidOlibanum comp. Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-7215-3Olibanum comp.60 mL in 1 BOTTLE, DROPPERLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-7215OLIBANUM COMP. LIQUID [URIEL PHARMACY, INC]1Current NDC, 1 package rows20250210_2d8fef55-9fd6-e56d-e063-6294a90af6a7.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-721548951-7215-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSEJ2B2A4N98GIACT
WATER059QF0KO0RIACT
OLIBANUMR9XLF1R1WMACTIB
ALCOHOL3K9958V90MIACT
MYRRHJC71GJ1F3LACTIB
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 comp.OLIBANUM COMP.Uriel Pharmacy, Inc2d8fef55-9fd6-e56d-e063-6294a90af6a72025-02-07WarningsExact identifier
ndc (package): 48951-7215-3
ndc (product): 48951-7215
ndc11 (package): 48951721503
spl id: 2d8fef55-9fd7-e56d-e063-6294a90af6a7
spl set id: 2d8fef55-9fd6-e56d-e063-6294a90af6a7

Reported adverse events (FAERS/openFDA)#

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