FDA.reportPublic FDA data

Secale Betula

Manufacturer
Uriel Pharmacy Inc.
Effective date
2021-07-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:14:46

Label at a glance#

ProductSecale Betula
Active ingredientARNICA MONTANA, BETULA PENDULA LEAF, CLAVICEPS PURPUREA SCLEROTIUM, LEAD SULFIDE, BOS TAURUS EYE, BETULA PENDULA BARK, LEVISTICUM OFFICINALE ROOT, TOBACCO LEAF
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: Betula e fol. (Silver birch leaves) 3X, Betula e cort. (Silver birch bark) 4X, Levisticum (Lovage) 6X, Nicotiana (Tobacco) 6X, Secale corn. e grano (Ergot) 6X, Galena (Lead glance) 8X, Retina et chor. (Bovine retina and choroid) 8X, Arnica 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
Uriel, East Troy, WI 53120
www.urielpharmacy.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Secale Betula AmpulesSecale Betula Ampules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8379-1Secale Betula10 in 1 BOXLIQUID102
48951-8379-1Secale Betula1 mL in 1 AMPULELIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8379SECALE BETULA LIQUID [URIEL PHARMACY INC.]2Legacy NDC, 2 package rows20210731_c7a4db79-e2fd-f524-e053-2a95a90a7a16.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
48951-837948951-8379-1

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
ARNICA MONTANAO80TY208ZWACTIB
SODIUM CHLORIDE451W47IQ8XIACT
BETULA PENDULA LEAF5HW39H9KDHACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
LEAD SULFIDE2425D15SYMACTIB
BOS TAURUS EYEVTW461N43PACTIB
BETULA PENDULA BARK40S83Y133CACTIB
LEVISTICUM OFFICINALE ROOT46QZ19OEX8ACTIB
WATER059QF0KO0RIACT
TOBACCO LEAF6YR2608RSUACTIB

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
c85bc036-7a64-7033-e053-2a95a90a03e5c7a4db79-e2fd-f524-e053-2a95a90a7a162021-07-30WarningsExact identifier
spl id: c85bc036-7a64-7033-e053-2a95a90a03e5
spl set id: c7a4db79-e2fd-f524-e053-2a95a90a7a16

Reported adverse events (FAERS/openFDA)#

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