FDA.reportPublic FDA data

Hydrangea arborescens

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-11-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:23:35

Label at a glance#

ProductHydrangea arborescens
Active ingredientHYDRANGEA ARBORESCENS ROOT
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Hydrangea arborescens 30C

INDICATIONS & USAGE SECTION

Bedwetting*

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

5 pellets 3 times a day until symptoms are relieved

SPL UNCLASSIFIED SECTION

Do not use if pellet dispenser seal is broken, contains approx 80 pellets

INACTIVE INGREDIENT SECTION

lactose, sucrose

OTC - QUESTIONS SECTION

1-800-BOIRON-1, Newtown Square, PA 19073-3267, info@boironusa.com

SPL UNCLASSIFIED SECTION

These "Uses" have not been evaluated by the FDA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-2514-412023-11-13C16284748780-1f386c649-b6eb-0266-e053-dadaa90a7c1aHydrangea arborescens
0220-2514-412023-01-30C16284748780-1f386c649-b6eb-0266-e053-dadaa90a7c1aHydrangea arborescens

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-2514-41Hydrangea arborescens30 [hp_C] in 1 TUBEPELLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-2514HYDRANGEA ARBORESCENS (HYDRANGEA ARBORESCENS ROOT) PELLET [BOIRON]3Current NDC, Legacy NDC, 1 package rows20231114_7c747cb5-7493-1d0f-e053-2991aa0ad10b.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
0220-25140220-2514-41

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
SUCROSEC151H8M554IACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
HYDRANGEA ARBORESCENS ROOTSFK828Q2DEACTIB

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
Hydrangea arborescensHYDRANGEA ARBORESCENS ROOTBoiron7c747cb5-7493-1d0f-e053-2991aa0ad10b2023-11-13Exact identifier
ndc (package): 0220-2514-41
ndc (product): 0220-2514
ndc11 (package): 00220251441
spl id: 0a0d95f0-5c6b-6afd-e063-6394a90a6ae6
spl set id: 7c747cb5-7493-1d0f-e053-2991aa0ad10b

Reported adverse events (FAERS/openFDA)#

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