FDA.reportPublic FDA data

Phytolacca decandra

Manufacturer
Washington Homeopathic Products
Effective date
2023-10-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:22:46

Label at a glance#

ProductPhytolacca decandra
Active ingredientPHYTOLACCA AMERICANA ROOT
Label structure9 sections

Indications and uses

To relieve the symptoms of sore throat.

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

PHYTOLACCA

USES

OTC - PURPOSE SECTION

To relieve the symptoms of sore throat.

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:

PHYTOLACCA Sore Throat

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

RECENT MAJOR CHANGES SECTION

Indication: Sore throat

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

The OTC potency range of PHYTOLACCA is 2x–30x, 1c–30c, 200c, 1m, 10m, 50m, and CM.

Availability is subject to change.

Phytolacca2023Phytolacca2023

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
68428-563-032025-01-30C16284748780-12cef2736-85b6-d83d-e063-dadaa90ab31fDRUG FACTS
68428-563-052025-01-30C16284748780-12cef2736-85b6-d83d-e063-dadaa90ab31fDRUG FACTS
68428-563-062025-01-30C16284748780-12cef2736-85b6-d83d-e063-dadaa90ab31fDRUG FACTS
68428-563-112025-01-30C16284748780-12cef2736-85b6-d83d-e063-dadaa90ab31fDRUG FACTS
68428-563-122025-01-30C16284748780-12cef2736-85b6-d83d-e063-dadaa90ab31fDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68428-563-03Phytolacca decandra75 in 1 VIAL, GLASSPELLET755
68428-563-05Phytolacca decandra150 in 1 VIAL, GLASSPELLET1505
68428-563-06Phytolacca decandra1200 in 1 BOTTLE, GLASSPELLET12005
68428-563-11Phytolacca decandra300 in 1 BOTTLE, GLASSPELLET3005
68428-563-12Phytolacca decandra600 in 1 BOTTLE, GLASSPELLET6005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68428-563PHYTOLACCA DECANDRA (PHYTOLACCA AMERICANA ROOT) PELLET [WASHINGTON HOMEOPATHIC PRODUCTS]5Legacy NDC, 5 package rows20231020_48e3e81b-7cba-4c37-8002-d9bd6cd33220.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
68428-56368428-563-03, 68428-563-05, 68428-563-11, 68428-563-12, 68428-563-06

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
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB

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
081719c1-49e2-825f-e063-6294a90a70d348e3e81b-7cba-4c37-8002-d9bd6cd332202023-10-19WarningsExact identifier
spl id: 081719c1-49e2-825f-e063-6294a90a70d3
spl set id: 48e3e81b-7cba-4c37-8002-d9bd6cd33220

Reported adverse events (FAERS/openFDA)#

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