MedPath

Peppermint

Generic Name
Peppermint
Drug Type
Biotech
Unique Ingredient Identifier
V95R5KMY2B

Overview

Peppermint allergenic extract is used in allergenic testing.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: Nov 1, 2025

A Comprehensive Monograph on Peppermint Oil (Mentha x piperita L.): Pharmacology, Clinical Evidence, and Regulatory Status

1.0 Substance Identification and Chemical Profile

1.1 Botanical Origin and Nomenclature

Peppermint, identified in the DrugBank database under the primary entry for Peppermint Oil (DB11198) and as an investigational substance (DB10984), is a well-known aromatic herbaceous plant belonging to the Lamiaceae family.[1] The therapeutic agent is the essential oil, scientifically termed Menthae piperitae aetheroleum, which is a complex natural product derived from the plant Mentha x piperita L..[3] This plant is not a distinct species but rather a natural interspecific hybrid of water mint (Mentha aquatica) and spearmint (Mentha spicata).[1] The essential oil is typically obtained through steam distillation of the fresh or partly wilted aerial parts of the flowering plant, including the stem, leaves, and flowers.[1]

The classification of Peppermint as "Biotech" in the initial query (DrugBank ID DB10984) is a misnomer. As a substance directly extracted from a plant, Peppermint Oil is correctly categorized as a herbal medicinal product or a natural health product. It is not a product derived from biotechnological processes such as recombinant DNA technology or monoclonal antibody production. Its long history of use in traditional and herbal medicine for digestive and respiratory ailments predates modern biotechnology by centuries.[5][ The rigorous scientific investigation and regulation it now undergoes, however, place it at the intersection of traditional phytotherapy and modern, evidence-based pharmacology.]

Peppermint Oil is utilized in a wide array of applications, including as a flavoring agent in foods and beverages, a fragrance component in cosmetics and hygienic products, and as an active ingredient in over-the-counter (OTC) pharmaceutical preparations for topical and oral use.[2]

1.2 Chemical Composition

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Nelco Laboratories, Inc.
36987-1728
INTRADERMAL, SUBCUTANEOUS
0.1 g in 1 mL
12/9/2009
Nelco Laboratories, Inc.
36987-1729
INTRADERMAL, SUBCUTANEOUS
0.1 g in 1 mL
12/9/2009
Nelco Laboratories, Inc.
36987-1726
INTRADERMAL, SUBCUTANEOUS
0.05 g in 1 mL
12/9/2009
Allergy Laboratories, Inc.
54575-486
PERCUTANEOUS, SUBCUTANEOUS
1 g in 20 mL
3/15/2011
Jiangxi Yudexi Pharmaceutical Co., LTD
85248-003
TOPICAL
10 g in 100 g
4/22/2025
Nelco Laboratories, Inc.
36987-1727
INTRADERMAL, SUBCUTANEOUS
0.05 g in 1 mL
12/9/2009

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
BIOSTRATH NO 6
bio-strath ag
00661112
Suspension - Oral
.05 ML / ML
12/31/1989
HOMEOPATHIC THROAT SPRAY
herbalife international of america, inc.
02239375
Spray - Oral
6 X / X
11/1/1999
UNDA 46
seroyal international inc.
02233262
Liquid ,  Drops ,  Granules ,  Pellet ,  Tablet - Oral
4 X
4/6/1998
HERBAL ANTI-NAUSEA FORMULA
quest vitamins a div of purity life health products
02230009
Capsule - Oral
50 MG / CAP
2/8/1999
DYGEST
creative nutrition canada corp.
00665975
Tablet - Oral
50 MG
12/31/1987
BLG-X
nature's sunshine products inc.
02232885
Capsule - Oral
55 MG / CAP
2/11/1998
CONDURANGOPLEX
bio active canada ltd.
02233586
Liquid - Oral
1 X
5/26/1998
NAUS-OVER
health 2000 inc.
02239662
Capsule - Oral
260 MG
N/A
CELLOPT
terra botanica products ltd.
02233306
Liquid - Oral
1 X
5/25/1998
DR SCHIEFFER NERVE HERB TEA NR 6
dr nachf dr. nachf grunitz chemische erzeugnisse
00113018
Leaf - Oral
10 %
12/31/1951

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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