MedPath

Black cohosh

Generic Name
Black cohosh
Drug Type
Biotech
Unique Ingredient Identifier
K73E24S6X9

Overview

Black cohosh (Actaea racemosa or Cimicifuga racemosa), a member of the buttercup family, is a perennial plant which native to North America. Historical names for this plant include snakeroot, black bugbane, rattleweed, macrotys, and rheumatism weed. Black cohosh has a long history of use. Native Americans used it for its purported benefits in treating musculoskeletal pain, fever, cough, pneumonia, sluggish labor, and menstrual irregularities. European settlers were said to use black cohosh as a tonic to support female reproductive health. Hormone replacement therapy (HRT) is the standard treatment for early symptoms in post-menopausal women, however, increases the risk of stroke, heart diseases, as well as breast cancer in older women. Various studies have shown that the number of post-menopausal women using hormone replacement therapy is currently low and that the effects of hormone replacement therapy in reducing menopausal symptoms are not as positive as expected. For these reasons, there has been a trend toward using alternative therapies to relieve menopausal symptoms. Black cohosh has been associated with serious safety concerns. Results from studies suggest that C. racemosa possesses a central activity instead of a hormonal effect. The American College of Obstetrics and Gynecology guidelines on the use of botanicals, such as black cohosh, for the management of menopausal symptoms the use of for up to six months, especially in treating the symptoms of sleep and mood disturbance, and hot flushes.

Indication

Treatment of menopausal symptoms and menstrual dysfunction .

Associated Conditions

  • Menopausal Symptoms
  • Menopause Symptoms

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
BM Private Limited
85816-2250
ORAL
30 [hp_X] in 1 mL
7/31/2025
Apcco Labs, Inc
82126-002
VAGINAL
2 [hp_X] in 1 mg
6/18/2025
King Bio Inc.
57955-2822
ORAL
10 [hp_X] in 59 mL
5/20/2025
Bestmade Natural Products
82969-5041
ORAL
30 [hp_C] in 30 [hp_C]
5/27/2025
King Bio Inc.
57955-5276
ORAL
10 [hp_X] in 59 mL
5/19/2025
King Bio Inc.
57955-9150
ORAL
10 [hp_X] in 59 mL
5/19/2025
BM Private Limited
85816-2060
ORAL
6 [hp_X] in 1 mL
7/30/2025
King Bio Inc.
57955-6163
ORAL
10 [hp_X] in 59 mL
5/19/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Lifetime Menopause Revival Premium Gold
297837
Medicine
A
12/20/2017
Women's PMS Relieve Tablets
488730
Medicine
A
5/14/2025
SUMMIT GUAIACUM COMPLEX oral liquid bottle
45830
H.E Kugelman & Co
Medicine
A
7/21/1993
Hilde Hemmes' Herbals Swedish Bitters Capsules
82846
Medicine
A
5/21/2002

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ACTAEA RACEMOSA
dolisos canada inc.
N/A
Globules ,  Liquid ,  Granules - Oral
1 X
1/5/1998
R-24 DPS
dr reckeweg canada
02090449
Drops - Oral
6 D / 10 ML
12/31/1994
ACTAEA RACEMOSA GRANULE 1DH - 30CH
dolisos laboratoires s.a.
00698482
Tablet - Oral
1 DH / DH
12/31/1987
ETHICAL HERBALS MENSTRUAL/MENOPAUSE SYMPTOM RELIEF
ashbury research corporation
02240661
Tablet - Oral
75 MG / TAB
N/A
ACTAEA RACEMOSA
seroyal international inc.
02233077
Granules ,  Liquid ,  Tablet ,  Globules ,  Drops ,  Pellet - Oral
1 X
4/6/1998
CIMICIFUGA RACEMOSA LIQUID (S#179)
total health centre
02201402
Liquid - Sublingual
1 X / ML
6/1/1997
MYOREL
thorne research canada ltd.
02240324
Capsule - Oral
50 MG
N/A
ACTAEA RACEMOSA GOUTTE 4CH-30CH
dolisos laboratoires s.a.
00700282
Drops - Oral
1 DH / DH
12/31/1987
CIMICIFUGA-HOMACCORD
01969358
Drops - Oral
.8 ML / 100 ML
12/31/1992
GYNOPT
terra botanica products ltd.
02233333
Liquid - Oral
3 X
6/3/1998

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
REMIFEMIN COMPRIMIDOS
Schaper & Bruemmer Gmbh & Co. Kg
64493
COMPRIMIDO
Sin Receta
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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