FDA.reportPublic FDA data

Berberis Vulgaris 30C

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2022-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:19:24

Label at a glance#

ProductBerberis Vulgaris 30C
Active ingredientBERBERIS VULGARIS ROOT BARK
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT (HPUS*):

Berberis Vulgaris 30C

OTC - PURPOSE SECTION

USES: Temporarily relieves minor discomfort in the extremities.**

INDICATIONS & USAGE SECTION

USES: Temporarily relieves minor discomfort in the extremities.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

*The letters "HPUS" indicate the component in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0169-1

BERBERIS VULGARIS 30C

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0169-12023-01-10C16284748780-1d6a99b39-ba37-a426-e053-dadaa90af4c2BERBERIS VULGARIS 30C
43406-0169-12022-01-28C16284748780-1d6a99b39-ba37-a426-e053-dadaa90af4c2BERBERIS VULGARIS 30C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0169-1Berberis Vulgaris 30C30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0169BERBERIS VULGARIS 30C (BERBERIS VULGARIS ROOT BARK) LIQUID [NATURAL CREATIONS, INC.]3Current NDC, Legacy NDC, 1 package rows20230111_2cfbfa8a-9225-4c29-8fe0-34b956d6e6b4.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
43406-016943406-0169-1

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
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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 Vulgaris 30CBERBERIS VULGARIS ROOT BARKNatural Creations, Inc.2cfbfa8a-9225-4c29-8fe0-34b956d6e6b42022-12-19WarningsExact identifier
ndc (package): 43406-0169-1
ndc (product): 43406-0169
ndc11 (package): 43406016901
spl id: 606eb79e-6325-44c3-804c-e2cc327f8343
spl set id: 2cfbfa8a-9225-4c29-8fe0-34b956d6e6b4

Reported adverse events (FAERS/openFDA)#

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