FDA.reportPublic FDA data

Hedera helix

Manufacturer
Washington Homeopathic Products
Effective date
2018-07-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:10:29

Label at a glance#

ProductHedera helix
Active ingredientHEDERA HELIX FLOWERING TWIG
Label structure8 sections

Indications and uses

To relieve the symptoms of Hemorrhoids.

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

HEDERA

USES

OTC - PURPOSE SECTION

To relieve the symptoms of Hemorrhoids.

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:

HEDERA   Hemorrhoids

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 HEDERA is 3x–30x, 2c–30c, 200c, 1m, 10m, 50m, and CM.

Availability is subject to change.

LabelLabel

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
68428-420-032020-01-31C16284748780-19d75b9d0-a195-f424-e053-dadaa90a57ceDRUG FACTS
68428-420-052020-01-31C16284748780-19d75b9d0-a195-f424-e053-dadaa90a57ceDRUG FACTS
68428-420-062020-01-31C16284748780-19d75b9d0-a195-f424-e053-dadaa90a57ceDRUG FACTS
68428-420-112020-01-31C16284748780-19d75b9d0-a195-f424-e053-dadaa90a57ceDRUG FACTS
68428-420-122020-01-31C16284748780-19d75b9d0-a195-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68428-420-03Hedera helix75 in 1 VIAL, GLASSPELLET752
68428-420-05Hedera helix150 in 1 VIAL, GLASSPELLET1502
68428-420-06Hedera helix1200 in 1 BOTTLE, GLASSPELLET12002
68428-420-11Hedera helix300 in 1 BOTTLE, GLASSPELLET3002
68428-420-12Hedera helix600 in 1 BOTTLE, GLASSPELLET6002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68428-420HEDERA HELIX (HEDERA HELIX FLOWERING TWIG) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]2Legacy NDC, 5 package rows20181019_9d9768fd-a871-4c87-9932-7b3978e424e5.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
68428-42068428-420-03, 68428-420-05, 68428-420-11, 68428-420-12, 68428-420-06

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
HEDERA HELIX FLOWERING TWIG3D10KUA6BMACTIB

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
75c1466a-a55b-2fcf-e053-2a91aa0a776e9d9768fd-a871-4c87-9932-7b3978e424e52018-07-15WarningsExact identifier
spl id: 75c1466a-a55b-2fcf-e053-2a91aa0a776e
spl set id: 9d9768fd-a871-4c87-9932-7b3978e424e5

Reported adverse events (FAERS/openFDA)#

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