FDA.reportPublic FDA data

Graphite Belladonna

Manufacturer
Uriel Pharmacy, Inc.
Effective date
2021-10-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:15:08

Label at a glance#

ProductGraphite Belladonna
Active ingredientAMANITA MUSCARIA FRUITING BODY, TIN, BOS TAURUS BRAIN, HELLEBORUS NIGER ROOT, ATROPA BELLADONNA, GRAPHITE, SILVER SULFIDE
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE.

DOSAGE & ADMINISTRATION SECTION

Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Helleborus (Christmas rose) 4X, Agaricus (Fly agaric mushroom) 6X, Argentite (Cubic silver sulfide) 6X,
Regio substantia nigra (Bovine nucleus in the midbrain) 6X, Stannum met. (Metallic tin) 20X, Atropa belladonna (Nightshade) 30X,
Graphite (Foliated crystalline carbon) 30X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt, Lactose

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.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Graphite Belladonna AmpulesGraphite Belladonna Ampules

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-5126-1Graphite Belladonna1 mL in 1 AMPULELIQUID11
48951-5126-1Graphite Belladonna10 in 1 BOXLIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-5126GRAPHITE BELLADONNA LIQUID [URIEL PHARMACY, INC.]1Legacy NDC, 2 package rows20211028_cf338901-6b22-4cd3-e053-2995a90a1060.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-512648951-5126-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMANITA MUSCARIA FRUITING BODYDIF093I037ACTIB
TIN387GMG9FH5ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
BOS TAURUS BRAINA1YEE2DB8ZACTIB
HELLEBORUS NIGER ROOT608DGJ6815ACTIB
WATER059QF0KO0RIACT
ATROPA BELLADONNAWQZ3G9PF0HACTIB
GRAPHITE4QQN74LH4OACTIB
SILVER SULFIDE9ZB10YHC1CACTIB

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
cf338901-6b23-4cd3-e053-2995a90a1060cf338901-6b22-4cd3-e053-2995a90a10602021-10-25WarningsExact identifier
spl id: cf338901-6b23-4cd3-e053-2995a90a1060
spl set id: cf338901-6b22-4cd3-e053-2995a90a1060

Reported adverse events (FAERS/openFDA)#

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