FDA.reportPublic FDA data

Celandine Honey

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-04-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:26:33

Label at a glance#

ProductCelandine Honey
Active ingredientCHELIDONIUM MAJUS, HONEY
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE.

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: Chelidonium e flor. (Greater celandine) 4X, Mel (Honey) 4X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt, Sodium bicarbonate, Rose oil

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. 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. USE WITHIN 30 DAYS OF OPENING.
Opened on:_________________

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Celandine Honey LiquidCelandine Honey LiquidCelandine Honey Liquid 10mLCelandine Honey Liquid 10mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-3248-1Celandine Honey10 mL in 1 BOTTLE, DROPPERLIQUID102
48951-3248-1Celandine Honey1 in 1 BAGLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-3248CELANDINE HONEY LIQUID [URIEL PHARMACY INC.]2Legacy NDC, 2 package rows20240403_c9da739a-0223-7d97-e053-2995a90a6bfa.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
48951-324848951-3248-1

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
CHELIDONIUM MAJUS7E889U5RNNACTIB
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
ROSE OILWUB68Y35M7IACT
HONEYY9H1V576FHACTIB
SODIUM BICARBONATE8MDF5V39QOIACT

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
152184a0-6a3d-0412-e063-6294a90a5214c9da739a-0223-7d97-e053-2995a90a6bfa2024-04-02WarningsExact identifier
spl id: 152184a0-6a3d-0412-e063-6294a90a5214
spl set id: c9da739a-0223-7d97-e053-2995a90a6bfa

Reported adverse events (FAERS/openFDA)#

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