MedPath

Belladonna

Generic Name
Belladonna
Drug Type
Biotech
Unique Ingredient Identifier
WQZ3G9PF0H

Overview

Belladonna, also known as atropa belladonna or deadly nightshade, is a perennial herbaceous plant in the nightshade family Solanaceae. Its roots, leaves and fruits contain Hyoscyamine, Scopolamine, and mostly, Atropine. These alkaloids are naturally-occurring muscarinic antagonists. Atropine is a non-selective muscarinic antagonist that is mainly used as an adjunct for anaesthesia. The name "belladonna" originates from the Italian words "beautiful woman" and the historical use of herb eye-drops by women to dilate the pupils of the eyes for aesthetic purposes. Belladonna is a poisonous plant and belladonna intoxication from accidental ingestion may result in a severe anticholinergic syndrome, which is associated with both central and peripheral manifestations .

Indication

No therapeutic indications.

Associated Conditions

  • Bloating
  • Heartburn
  • Menopausal Symptoms
  • Poisoning of the Intestine
  • Poisoning of the Stomach
  • Reflux Acid
  • Belching
  • Gastrointestinal spasms

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Newton Laboratories, Inc.
55714-2596
ORAL
15 [hp_X] in 1 mL
5/21/2025
King Bio Inc.
57955-6031
ORAL
10 [hp_X] in 59 mL
5/23/2025
Newton Laboratories, Inc.
55714-4862
ORAL
15 [hp_X] in 1 mL
5/21/2025
Newton Laboratories, Inc.
55714-4748
ORAL
15 [hp_X] in 1 mL
8/20/2025
Bestmade Natural Products
82969-6015
AURICULAR (OTIC)
30 [hp_C] in 30 [hp_C]
5/27/2025
King Bio Inc.
57955-2830
ORAL
10 [hp_X] in 59 mL
5/20/2025
Laboratoire Schmidt-Nagel Inc.
73296-004
SUBLINGUAL, ORAL
30 [hp_X] in 1 g
5/20/2025
Newton Laboratories, Inc.
55714-2467
ORAL
15 [hp_X] in 1 mL
8/27/2025
Peaceful Mountain, Inc.
43846-0079
TOPICAL
12 [hp_X] in 1 g
5/21/2025
Padagis US LLC
0574-7045
RECTAL
16.2 mg in 1 1
8/8/2018

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
TRI-MAG-GEL B TAB
N/A
N/A
N/A
7/23/1981

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Traumeel Cream
376439
Medicine
A
10/15/2021
BRAUER DRY COUGH
124132
Medicine
A
12/10/2005
Baby & Child Teething Gel
347981
Medicine
A
11/11/2020
Mucosa compositum N
124349
Medicine
A
12/19/2005
TRAUMEEL S
82622
Medicine
A
5/1/2002

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
MEDIPLEX 610 - LIQ
mediherb inc.
02117002
Liquid - Oral
14 X / ML
12/19/1996
APIS BELLADONNA
02232697
Liquid ,  Pellet - Oral
3 D
3/30/1998
PREMNIX HP
terra botanica products ltd.
02233359
Liquid - Oral
30 X
5/25/1998
HOMEO-FORM R - GRANULES
homeocan inc.
02151413
Tablet - Oral
9 X
12/31/1995
SINIX
terra botanica products ltd.
02233367
Liquid - Oral
30 X
5/25/1998
HEPTOTHESAN B57-LIQ
professional health products
02157799
Liquid - Oral
4 D / ML
12/31/1996
WIGRAINE TAB
organon canada ltd ltee
00489220
Tablet - Oral
.1 MG / TAB
12/31/1980
DROSETUX
dolisos laboratoires s.a.
02242696
Syrup - Oral
3 CH / 250 ML
10/6/2000
BELLADONNA-HOMACCORD
02231981
Drops - Oral
3 D
8/28/1997
BR-NIX SPRAY
terra botanica products ltd.
02233303
Liquid - Topical
12 X
5/25/1998

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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