Symphytum officinale

Manufacturer: Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC
Effective date: 2026-01-08
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: monthly-update
Hydrated at: 2026-06-03 17:50:32

Label at a glance#

ProductSymphytum officinale 7139

Active ingredientCOMFREY ROOT

Label structure9 sections

Dosage and administration

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Symphytum officinale 6X, 9X, 12X, 30X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

Use according to standard homeopathic indications for self-limiting conditions. Common Materia Medica indications: minor joint pain and injury, prickling pain.*

OTC - PURPOSE SECTION

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

WARNINGS

WARNINGS SECTION

In case of overdose, get medical help or contact a poison control center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare professional before use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

20% ethanol, purified water.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Symphytum officinale

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Label image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63083-7139-1	2026-01-09	C162847	48780-1	1030e365-1735-111a-e063-dadaa90a10e2	DSYM
63083-7139-1	2026-01-09	C162847	48780-1	1030e365-1735-111a-e063-dadaa90a10e2	DSYM
63083-7139-1	2024-01-30	C162847	48780-1	1030e365-1735-111a-e063-dadaa90a10e2	DSYM
63083-7139-1	2024-01-30	C162847	48780-1	1030e365-1735-111a-e063-dadaa90a10e2	DSYM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63083-7139-1	Symphytum officinale7139	29.5 mL in 1 BOTTLE, DROPPER	LIQUID	29.5		2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Symphytum officinale 7139
Symphytum officinale
COMFREY ROOT
ALCOHOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63083-7139	63083-7139-1

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
Name	UNII	Kind
COMFREY ROOT	M9VVZ08EKQ	ACTIB
ALCOHOL	3K9958V90M	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
1	2019-08-15	full-release	2026-06-01 02:16:53

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Symphytum officinale 7139	SYMPHYTUM OFFICINALE	Professional Complementary Health Formulas	3967a0bd-d08b-4154-b79b-a9771872e8ed	2026-01-08	Warnings	Exact identifier ndc (package): 63083-7139-1 ndc (product): 63083-7139 ndc11 (package): 63083713901 spl id: 9ca84beb-bc5b-4c99-98bc-d831519b4731 spl set id: 3967a0bd-d08b-4154-b79b-a9771872e8ed

Reported adverse events (FAERS/openFDA)#

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