FDA.reportPublic FDA data

Colchicum Chelidonium

Manufacturer
Uriel Pharmacy, Inc.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:35:38

Label at a glance#

ProductColchicum Chelidonium
Active ingredientCHELIDONIUM MAJUS FLOWERING TOP, COLCHICUM AUTUMNALE WHOLE, SPONGIA OFFICINALIS SKELETON, ROASTED
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 Ingredient: Colchicum e tub. Inc.(Meadow saffron) 2X, Spongia tosta (Roasted sea sponge) 2X, Chelidonium e flos. Inc. (Greater celandine) 3X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Lanolin, Sunflower seed oil, Water, Yellow beeswax, Lanolin alcohol

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, 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
Made with care by Uriel, East Troy, WI 53120
shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colchicum Chelidonium Ointment.Colchicum Chelidonium Ointment.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-3271-5Colchicum Chelidonium30 g in 1 TUBEOINTMENT302

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
48951-327148951-3271-5

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
SUNFLOWER OIL3W1JG795YIIACT
CHELIDONIUM MAJUS FLOWERING TOPO9HP59XU7FACTIB
COLCHICUM AUTUMNALE WHOLEW79255C628ACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
LANOLIN ALCOHOL884C3FA9HEIACT
BEESWAX2ZA36H0S2VIACT
LANOLIN7EV65EAW6HIACT
WATER059QF0KO0RIACT

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
Colchicum ChelidoniumCOLCHICUM CHELIDONIUMUriel Pharmacy, Inc.26a950dd-36b0-e512-e063-6394a90a82c72025-12-04WarningsExact identifier
ndc (package): 48951-3271-5
ndc (product): 48951-3271
ndc11 (package): 48951327105
spl id: 4524b154-347f-2dd0-e063-6294a90abfce
spl set id: 26a950dd-36b0-e512-e063-6394a90a82c7

Reported adverse events (FAERS/openFDA)#

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