Overview
Peppermint allergenic extract is used in allergenic testing.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/04/05 | Phase 3 | Completed | |||
2022/09/29 | Not Applicable | Completed | |||
2021/04/29 | Phase 3 | Completed | |||
2016/03/23 | Phase 3 | Completed | |||
2014/06/13 | Not Applicable | UNKNOWN | Central DuPage Hospital | ||
2007/04/05 | Not Applicable | Completed | Tabriz University |
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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