FDA.reportPublic FDA data

ONION

Manufacturer
Uriel Pharmacy, Inc
Effective date
2025-01-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:30:05

Label at a glance#

ProductArchangelica comp.
Active ingredientONION, ANGELICA ARCHANGELICA ROOT, GARLIC
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR TOPICAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Apply to skin as needed. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: . Allium cepa (Onion) 2X, Allium sativa (Garlic) 2X, Archangelica e rad Dec. (Longwort) 1X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Organic Olive oil, Lanolin, Sunflower seed oil, Yellow beeswax, Lanolin alcohol, Distilled water, Honey, Scotch pine needle oil, Dwarf pine oil, Lavender oil, Rosemary oil

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Uses: Temporary relief of cough.

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, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Archangelica comp. OintmentArchangelica comp. Ointment

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1391-2Archangelica comp.30 g in 1 BOTTLE, GLASSOINTMENT301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1391ARCHANGELICA COMP. OINTMENT [URIEL PHARMACY, INC]1Current NDC, 1 package rows20250108_2b105dca-ed2e-bd26-e063-6294a90a654c.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-139148951-1391-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ONION492225Q21HACTIB
PINE NEEDLE OIL (PINUS MUGO)6KF1RLN1CIIACT
ANGELICA ARCHANGELICA ROOTDTN01M69SNACTIB
LANOLIN7EV65EAW6HIACT
ROSEMARY OIL8LGU7VM393IACT
YELLOW WAX2ZA36H0S2VIACT
PINE NEEDLE OIL (PINUS SYLVESTRIS)5EXL5H740YIACT
OLIVE OIL6UYK2W1W1EIACT
SUNFLOWER OIL3W1JG795YIIACT
WATER059QF0KO0RIACT
LAVENDER OILZBP1YXW0H8IACT
GARLICV1V998DC17ACTIB
LANOLIN ALCOHOLS884C3FA9HEIACT
HONEYY9H1V576FHIACT

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
Archangelica comp.ARCHANGELICA COMP.Uriel Pharmacy, Inc2b105dca-ed2e-bd26-e063-6294a90a654c2025-01-06WarningsExact identifier
ndc (package): 48951-1391-2
ndc (product): 48951-1391
ndc11 (package): 48951139102
spl id: 2b105dca-ed2f-bd26-e063-6294a90a654c
spl set id: 2b105dca-ed2e-bd26-e063-6294a90a654c

Reported adverse events (FAERS/openFDA)#

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