FDA.reportPublic FDA data

Spigelia comp

Manufacturer
Uriel Pharmacy Inc.
Effective date
2020-12-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:01

Label at a glance#

ProductSpigelia comp
Active ingredientACONITUM NAPELLUS, SODIUM NITRITE, ARNICA MONTANA FLOWER, PHOSPHORUS, SPIGELIA MARILANDICA ROOT, SILVER NITRATE
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: Aconitum (Monkshood) 8X, Arnica 8X, Natrium nitrosum (Sodium nitrite) 8X, Spigelia (Pinkroots) 8X, Argentum nitricum (Silver nitrate) 10X, Phosphorus (Yellow phosphorus) 12X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt

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.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spigelia compSpigelia comp

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
70dd82cf-c501-052d-5d98-d42ef9849750Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8368-1Spigelia comp1 mL in 1 AMPULELIQUID11
48951-8368-1Spigelia comp10 in 1 BOXLIQUID101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8368SPIGELIA COMP LIQUID [URIEL PHARMACY INC.]1Legacy NDC, 2 package rows20201218_b699ea99-a011-2ecb-e053-2a95a90a6c29.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-836848951-8368-1

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
ACONITUM NAPELLUSU0NQ8555JDACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM NITRITEM0KG633D4FACTIM
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
WATER059QF0KO0RIACT
PHOSPHORUS27YLU75U4WACTIB
SPIGELIA MARILANDICA ROOT467D26HS0BACTIB
SILVER NITRATE95IT3W8JZEACTIB

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
b699ea99-a012-2ecb-e053-2a95a90a6c29b699ea99-a011-2ecb-e053-2a95a90a6c292020-12-16WarningsExact identifier
spl id: b699ea99-a012-2ecb-e053-2a95a90a6c29
spl set id: b699ea99-a011-2ecb-e053-2a95a90a6c29

Reported adverse events (FAERS/openFDA)#

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