FDA.reportPublic FDA data

Ear Formula

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-04-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:26:46

Label at a glance#

ProductEar Formula
Active ingredientLEVISTICUM OFFICINALE ROOT, PAPRIKA, ATROPA BELLADONNA, PULSATILLA VULGARIS, ACONITUM NAPELLUS, SILICON DIOXIDE
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: Levisticum (Lovage) 2X, Capsicum (Chili pepper) 3X, Atropa belladonna (Nightshade) 6X, Pulsatilla (Pasqueflower) 6X, Aconitum (Monkshood) 8X, Quartz (Rock crystal) 12X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled water, Propolis

"prepared using rhythmical processes"

OTC - PURPOSE SECTION

Use: Temporary relief of ear irritation.

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.

REFRIGERATE AFTER OPENING.
BEST WHEN USED WITHIN 30 DAYS OF OPENING BUT WILL KEEP LONGER IF REFRIGERATED.

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

Ear Formula LiquidEar Formula Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-4011-3Ear Formula60 mL in 1 BOTTLE, DROPPERLIQUID604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-4011EAR FORMULA LIQUID [URIEL PHARMACY INC.]4Legacy NDC, 1 package rows20240427_62f38022-c3f4-46d6-bd0f-b29360a2b141.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
COLLOIDAL SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
LEVISTICUM OFFICINALE ROOTACTIVE INGREDIENT46QZ19OEX81
PAPRIKAACTIVE INGREDIENTX72Z47861V1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
LEVISTICUM OFFICINALE ROOTACTIVE MOIETY46QZ19OEX81
PAPRIKAACTIVE MOIETYX72Z47861V1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOF1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-401148951-4011-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPOLIS WAX6Y8XYV2NOFIACT
LEVISTICUM OFFICINALE ROOT46QZ19OEX8ACTIB
WATER059QF0KO0RIACT
PAPRIKAX72Z47861VACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB

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
1702dcfe-6207-1233-e063-6294a90a778362f38022-c3f4-46d6-bd0f-b29360a2b1412024-04-26WarningsExact identifier
spl id: 1702dcfe-6207-1233-e063-6294a90a7783
spl set id: 62f38022-c3f4-46d6-bd0f-b29360a2b141

Reported adverse events (FAERS/openFDA)#

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