FDA.reportPublic FDA data

Calendula Combination

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 17:49:31

Label at a glance#

ProductCalendula Combination 9260
Active ingredientBELLIS PERENNIS WHOLE, CALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA WHOLE, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ACONITUM NAPELLUS WHOLE, ARNICA MONTANA WHOLE, ARTEMISIA ANNUA FLOWERING TOP, HYPERICUM PERFORATUM WHOLE, ACHILLEA MILLEFOLIUM WHOLE, AMARYLLIS BELLADONNA WHOLE, CALCIUM SULFIDE, COMFREY ROOT, ACTIVATED CHARCOAL, MERCURIUS SOLUBILIS
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

Bellis perennis 2X
Calendula officinalis 2X
Echinacea angustifolia 2X
Hamamelis virginiana 2X
Aconitum napellus 3X
Arnica montana 3X
Chamomilla 3X
Hypericum perforatum 3X
Millefolium 3X
Belladonna 4X
Hepar sulphuris calcareum 5X
Symphytum officinale 6X
Carbo vegetabilis 12X
Mercurius solubilis 12X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

For the temporary relief of mild pain, bruising, or swelling associated with minor injuries or wounds.*

OTC - PURPOSE SECTION

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

WARNINGS

WARNINGS SECTION

If symptoms do not improve or are accompanied by a fever, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

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

40% ethanol, purified water.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Calendula Combination

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Label imageLabel image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-9260-12026-01-09C16284748780-11030e365-1416-111a-e063-dadaa90a10e2R260
63083-9260-12026-01-09C16284748780-11030e365-1416-111a-e063-dadaa90a10e2R260
63083-9260-12024-01-30C16284748780-11030e365-1416-111a-e063-dadaa90a10e2R260
63083-9260-12024-01-30C16284748780-11030e365-1416-111a-e063-dadaa90a10e2R260

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-9260-1Calendula Combination926029.5 mL in 1 BOTTLE, DROPPERLIQUID29.52

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63083-926063083-9260-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BELLIS PERENNIS WHOLE2HU33I03UYACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
ARNICA MONTANA WHOLEO80TY208ZWACTIB
ARTEMISIA ANNUA FLOWERING TOP0UQK6O82OWACTIB
HYPERICUM PERFORATUM WHOLEXK4IUX8MNBACTIB
ACHILLEA MILLEFOLIUM WHOLE2FXJ6SW4PKACTIB
AMARYLLIS BELLADONNA WHOLE11B89M58UNACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
COMFREY ROOTM9VVZ08EKQACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-08-15full-release2026-06-01 02:15:47

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
Calendula Combination 9260CALENDULA COMBINATIONProfessional Complementary Health Formulas0e0770d8-680a-471a-b496-7105631ca6f42026-01-08WarningsExact identifier
ndc (package): 63083-9260-1
ndc (product): 63083-9260
ndc11 (package): 63083926001
spl id: f0f14b42-549c-4f37-982d-0a8a72b932b7
spl set id: 0e0770d8-680a-471a-b496-7105631ca6f4

Reported adverse events (FAERS/openFDA)#

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