FDA.reportPublic FDA data

Hydrastis canadensis

Manufacturer
Washington Homeopathic Products
Effective date
2023-10-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:22:46

Label at a glance#

ProductHydrastis canadensis
Active ingredientGOLDENSEAL
Label structure8 sections

Indications and uses

To relieve the symptoms of sinuses.

Dosage and administration

Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.  Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

HYDRASTIS

USES

OTC - PURPOSE SECTION

To relieve the symptoms of sinuses.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of reach of children.

INDICATIONS

INDICATIONS & USAGE SECTION

Indications:

HYDRASTIS   Sinuses

STOP USE AND ASK DOCTOR

WARNINGS SECTION

If symptoms persist/worsen or if pregnant/nursing, stop use and consult your practitioner.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.  Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sucrose/Lactose

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The OTC potency range of HYDRASTIS is 5x–30x, 3c–30c, 200c, 1m, 10m, 50m, and CM.
Hydrastis2023Hydrastis2023
Availability is subject to change.

All WHP single remedies are made to order; thus, the labels are printed on the same label stock as the orders are filled.

‘Bottle Size’ and ‘Potency’ vary on the label depending on customer choice.

Standard bottle sizes for pellet-form remedies are 2 dram, 4 dram, 1 ounce, 2 ounce, and 4 ounce.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68428-428-032025-01-30C16284748780-12cef2736-6f5b-d83d-e063-dadaa90ab31fDRUG FACTS
68428-428-052025-01-30C16284748780-12cef2736-6f5b-d83d-e063-dadaa90ab31fDRUG FACTS
68428-428-062025-01-30C16284748780-12cef2736-6f5b-d83d-e063-dadaa90ab31fDRUG FACTS
68428-428-112025-01-30C16284748780-12cef2736-6f5b-d83d-e063-dadaa90ab31fDRUG FACTS
68428-428-122025-01-30C16284748780-12cef2736-6f5b-d83d-e063-dadaa90ab31fDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68428-428-03Hydrastis canadensis75 in 1 VIAL, GLASSPELLET753
68428-428-05Hydrastis canadensis150 in 1 VIAL, GLASSPELLET1503
68428-428-06Hydrastis canadensis1200 in 1 BOTTLE, GLASSPELLET12003
68428-428-11Hydrastis canadensis300 in 1 BOTTLE, GLASSPELLET3003
68428-428-12Hydrastis canadensis600 in 1 BOTTLE, GLASSPELLET6003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68428-428HYDRASTIS CANADENSIS (GOLDENSEAL) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]3Legacy NDC, 5 package rows20231020_5fe7570b-811f-4e74-9851-c3285ddc15d5.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
68428-42868428-428-03, 68428-428-05, 68428-428-11, 68428-428-12, 68428-428-06

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
LACTOSEJ2B2A4N98GIACT
GOLDENSEALZW3Z11D0JVACTIB

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
081242ad-b00c-e723-e063-6394a90a50e15fe7570b-811f-4e74-9851-c3285ddc15d52023-10-19WarningsExact identifier
spl id: 081242ad-b00c-e723-e063-6394a90a50e1
spl set id: 5fe7570b-811f-4e74-9851-c3285ddc15d5

Reported adverse events (FAERS/openFDA)#

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