MedPath

Arnica montana

Generic Name
Arnica montana
Drug Type
Biotech
CAS Number
8057-65-6
Unique Ingredient Identifier
O80TY208ZW

Overview

Arnica montana is a plant/plant extract used in some OTC (over-the-counter) products. It is not an approved drug.

Indication

No indication information available.

Associated Conditions

  • Localized muscle pain
  • Pain

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV
34666-091
ORAL
6 [hp_C] in 1 1
8/13/2025
SEVENE USA
76472-5000
SUBLINGUAL
30 [hp_C] in 1 1
5/15/2025
Newton Laboratories, Inc.
55714-2596
ORAL
15 [hp_X] in 1 mL
5/21/2025
Newton Laboratories, Inc.
55714-4862
ORAL
15 [hp_X] in 1 mL
5/21/2025
Apcco Labs, Inc
82126-002
VAGINAL
2 [hp_X] in 1 mg
6/18/2025
Laboratoire Schmidt-Nagel Inc.
73296-000
ORAL, SUBLINGUAL
30 [hp_X] in 1 g
5/20/2025
BM Private Limited
85816-2224
ORAL
6 [hp_X] in 1 mL
7/31/2025
Newton Laboratories, Inc.
55714-2467
ORAL
15 [hp_X] in 1 mL
8/27/2025
BM Private Limited
85816-6012
ORAL
4 [hp_X] in 1 mL
7/31/2025
Renu Laboratories, LLC
76348-800
TOPICAL
1.12 g in 112 g
8/27/2025

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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
LM-TONIC III
bio active canada ltd.
02233646
Liquid - Oral
12 X
1/19/1998
MEDIPLEX 610 - LIQ
mediherb inc.
02117002
Liquid - Oral
5 X / ML
12/19/1996
SCIAT HP
bio active canada ltd.
02233679
Liquid - Oral
30 X
5/26/1998
HOMEO-FORM AR-TAB
homeocan inc.
02149281
Tablet - Oral
7 X
12/31/1995
ARNICA MONTANA
boericke and tafel inc.
02232101
Tablet ,  Globules - Sublingual
6 X
3/1/1998
DROSETUX
dolisos laboratoires s.a.
02242696
Syrup - Oral
3 CH / 250 ML
10/6/2000
PASCOTOX DROPS
pascoe gmbh
02195445
Drops - Oral
3 D / ML
12/4/2001
VARICO HP
terra botanica products ltd.
02233385
Liquid - Oral
30 X
5/25/1998
IN GEL
bio active canada ltd.
02233627
Gel - Topical
3 X
5/26/1998
ACIDUM PHOSPHORICUM PLEX
seroyal international inc.
02233076
Pellet ,  Tablet ,  Drops ,  Syrup ,  Granules ,  Liquid - Oral
3 X
4/6/1998

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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