FDA.reportPublic FDA data

Cimicifuga Racemosa

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#

ProductCimicifuga Racemosa
Active ingredientBLACK COHOSH
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS: ACTIVE INGREDIENTS: CIMICIFUGA RACEMOSA

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

CIMICIFUGA RACEMOSA

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

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

MD LabelMD Label

OTC - PURPOSE SECTION

To be used according to standard homeopathic indications.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66096-818-01Cimicifuga Racemosa6 [hp_C] in 1 TUBEPELLET63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66096-818CIMICIFUGA RACEMOSA PELLET [OHM PHARMA INC.]3Current NDC, Legacy NDC, 1 package rows20211231_46a7bfa2-50a8-41c4-9d64-2d6fd7e60465.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
66096-81866096-818-01

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
BLACK COHOSHK73E24S6X9ACTIB

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
Cimicifuga RacemosaCIMICIFUGA RACEMOSAOHM PHARMA INC.46a7bfa2-50a8-41c4-9d64-2d6fd7e604652021-12-30WarningsExact identifier
ndc (package): 66096-818-01
ndc (product): 66096-818
ndc11 (package): 66096081801
spl id: d45e62d3-b51d-530d-e053-2a95a90ac447
spl set id: 46a7bfa2-50a8-41c4-9d64-2d6fd7e60465

Reported adverse events (FAERS/openFDA)#

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