FDA.reportPublic FDA data

Fagopyrum esculentum

Manufacturer
Boiron | Boiron, Inc.
Effective date
2024-04-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:26:45

Label at a glance#

ProductFagopyrum esculentum
Active ingredientFAGOPYRUM ESCULENTUM
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Fagopyrum esculentum 200CK HPUS

Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).

INDICATIONS & USAGE SECTION

Uses: See symptoms on front panel.

Relieves itching worsened by heat *

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

INACTIVE INGREDIENT SECTION

lactose, sucrose

OTC - QUESTIONS SECTION

BoironUSA.com Info@boiron.com
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

Do not use if pellet dispenser seal is broken.
Contains approx.80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-2042-41Fagopyrum esculentum200 [kp_C] in 1 TUBEPELLET2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-2042FAGOPYRUM ESCULENTUM (FAGOPYRUM ESCULENTUM WHOLE) PELLET [BOIRON]1Current NDC, 1 package rows20240427_1705f1ab-4dca-eee7-e063-6294a90ae6ba.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-20420220-2042-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
SUCROSEC151H8M554IACT
FAGOPYRUM ESCULENTUMB10M69172NACTIB

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
Fagopyrum esculentumFAGOPYRUM ESCULENTUM WHOLEBoiron1705f1ab-4dca-eee7-e063-6294a90ae6ba2024-04-26Exact identifier
ndc (package): 0220-2042-41
ndc (product): 0220-2042
ndc11 (package): 00220204241
spl id: 1705f1ab-4dcb-eee7-e063-6294a90ae6ba
spl set id: 1705f1ab-4dca-eee7-e063-6294a90ae6ba

Reported adverse events (FAERS/openFDA)#

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