FDA.reportPublic FDA data

Berberis vulgaris

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:23:16

Label at a glance#

ProductBerberis vulgaris
Active ingredientBERBERIS VULGARIS ROOT BARK
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Berberis vulgaris 12C

(**contains 0.443 mg of the active ingredient per pellet)

INDICATIONS & USAGE SECTION

Skin rash with round, red patches and thin flakes*

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

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.

INACTIVE INGREDIENT SECTION

lactose, sucrose

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.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-0833-412023-11-09C16284748780-1f386c649-bb92-0266-e053-dadaa90a7c1aBerberis vulgaris 12C
0220-0833-412023-01-30C16284748780-1f386c649-bb92-0266-e053-dadaa90a7c1aBerberis vulgaris 12C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-0833-41Berberis vulgaris12 [hp_C] in 1 TUBEPELLET122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-0833BERBERIS VULGARIS (BERBERIS VULGARIS ROOT BARK ) PELLET [BOIRON]2Current NDC, Legacy NDC, 1 package rows20231110_8478b671-deee-e992-e053-2a91aa0abb9e.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-08330220-0833-41

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
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
SUCROSEC151H8M554IACT

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
Berberis vulgarisBERBERIS VULGARIS ROOT BARKBoiron8478b671-deee-e992-e053-2a91aa0abb9e2023-11-09Exact identifier
ndc (package): 0220-0833-41
ndc (product): 0220-0833
ndc11 (package): 00220083341
spl id: 09bab5f5-59d9-5c85-e063-6394a90a7848
spl set id: 8478b671-deee-e992-e053-2a91aa0abb9e