FDA.reportPublic FDA data

Calendula Officinalis

Manufacturer
OHM PHARMA INC.
Effective date
2021-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:15:32

Label at a glance#

ProductCalendula Officinalis
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS: ACTIVE INGREDIENTS: CALENDULA OFFICINALS

CONTENT: Approx. 100 Pellets

INDICATIONS & USAGE SECTION

USE: To be used according to standard homeopathic indications.

WARNINGS SECTION

WARNINGS: Keep out of reach of children. If pregnant or breast-feeding, ask a health care professional before use. Stop use and ask a health care professional if symptoms persist for more than 3 days or worsen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Dissolve 3-5 pellets under the tongue 3 times a day or as directed by a professional.

OTHER SAFETY INFORMATION

OTHER INFORMATION: Store at room temperature. Do not use if pellet dispenser seal is broken.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Organic sucrose, lactose free.

OTC - QUESTIONS SECTION

Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS). PRODUCT OF USA.

Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067

www.ohmpharma.com FDA Est # 3003231743

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALENDULA OFFICINALIS

The OTC Potency range from Calendula Officinalis 6X-30X, 3C-30C, 200C, 1M.

Standard bottle sizes for dilution-form can range from 30mL to 60mL.

MD Tube LabelMD Tube Label

OTC - PURPOSE SECTION

To be used according to standard homeopathic indications.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-807-01Calendula Officinalis6 [hp_C] in 1 TUBEPELLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-807CALENDULA OFFICINALIS PELLET [OHM PHARMA INC.]3Current NDC, Legacy NDC, 1 package rows20211231_2d3e1c87-aea2-4bd3-b596-a30d8aeef4ed.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66096-80766096-807-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB

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
Calendula OfficinalisCALENDULA OFFICINALISOHM PHARMA INC.2d3e1c87-aea2-4bd3-b596-a30d8aeef4ed2021-12-30WarningsExact identifier
ndc (package): 66096-807-01
ndc (product): 66096-807
ndc11 (package): 66096080701
spl id: d45e20fc-0dcb-4321-e053-2a95a90a08f6
spl set id: 2d3e1c87-aea2-4bd3-b596-a30d8aeef4ed

Reported adverse events (FAERS/openFDA)#

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