Overview
Chamomile 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
- Dry Eyes
Research Report
A Comprehensive Monograph on Chamomile (Matricaria recutita L. and Chamaemelum nobile L.): Phytochemistry, Pharmacology, Clinical Efficacy, and Regulatory Status
Introduction and Identification
Overview and Botanical Origin
Chamomile is one of the most ancient, widely utilized, and well-documented medicinal plants in the world, with a history of continuous use that spans millennia.[1] Its therapeutic applications were recorded by prominent Greek physicians such as Hippocrates and Galen, and it held a place of honor as one of the nine sacred herbs in Anglo-Saxon culture, underscoring its deep integration into traditional European medicine.[2] The name itself, derived from the Greek kamai melon meaning "ground apple," alludes to its pleasant, apple-like aroma.[3] In German traditional medicine, its reputation as a panacea is captured by the term "alles zutraut," meaning "capable of anything," a testament to its broad range of perceived benefits.[4] This global significance is further cemented by its official inclusion in the national pharmacopoeias of at least 26 countries.[2]
Botanically, the term "chamomile" primarily refers to two distinct but related species from the Asteraceae (daisy) family: German Chamomile (Matricaria recutita L., also known as Chamomilla recutita) and Roman or English Chamomile (Chamaemelum nobile L., formerly Anthemis nobilis).[4] While both are used therapeutically, German Chamomile is the subject of more extensive scientific investigation and is generally considered to be more potent, making it the focus of the majority of modern pharmacological and clinical research.[7] The dried flower heads of these plants are the parts used for medicinal preparations, which range from simple herbal infusions (teas) to highly concentrated extracts and essential oils.[2]
Classification and Nomenclature
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/01/19 | Phase 2 | Not yet recruiting | |||
2023/11/18 | Not Applicable | Not yet recruiting | |||
2023/07/19 | Phase 3 | Not yet recruiting | |||
2023/01/25 | Not Applicable | Recruiting | |||
2020/03/23 | Phase 2 | UNKNOWN | Hams Hamed Abdelrahman | ||
2019/01/04 | Phase 1 | UNKNOWN | |||
2017/03/31 | Phase 3 | Completed | John M. Daniel | ||
2014/09/26 | Phase 2 | Completed | University of Brasilia | ||
2010/02/22 | Phase 3 | Completed | |||
2001/02/05 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Guangzhou Houkea Biotechnology Co., Ltd. | 84984-006 | TOPICAL | 0.01 mg in 50 mg | 7/31/2025 | |
| Uriel Pharmacy, Inc | 48951-1406 | TOPICAL | 6 [hp_X] in 1 g | 9/8/2025 | |
| Bestmade Natural Products | 82969-5037 | ORAL | 30 [hp_C] in 30 [hp_C] | 5/27/2025 | |
| Hyland's Inc. | 54973-4124 | AURICULAR (OTIC) | 30 [hp_C] in 1 mL | 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. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Bug-grrr off Bites Stings and Itchy Things | 419100 | Medicine | A | 8/21/2023 | |
| Flexitol Naturals Eczema Cream | 213880 | Medicine | A | 8/27/2013 | |
| Gel-Lotion | 383731 | Medicine | A | 2/9/2022 | |
| CHAMOMILE OIL IN JOJOBA PURE ESSENTIAL OIL | 56939 | Medicine | A | 8/22/1996 | |
| ComforCleanse | 193422 | Medicine | A | 12/23/2011 | |
| xEO Mega | 327961 | Medicine | A | 12/20/2019 | |
| MediHerb Cascara Complex | 290970 | Medicine | A | 7/4/2017 | |
| MediHerb Cascara Complex | 455490 | Medicine | A | 7/17/2024 | |
| Topical Spray | 383732 | Medicine | A | 2/9/2022 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| R35 CHADONTIN LIQ | dr reckeweg and co | 00864609 | Drops - Oral | 4 D / D | 12/31/1989 |
| HERBON COUGH DROPS GLACIAL MINT | herbon naturals inc. | 02231756 | Drops - Oral | 1 MG / DROP | 9/8/1997 |
| CHAMOMILLA SIMILIAPLEX | sisu inc. | 02231874 | Liquid - Oral | 3 D | 5/30/1998 |
| HERBAL RELAX | wampole brands, a division of pangeo pharma (canada) inc. | 02237881 | Capsule - Oral | 460 MG | 11/5/1998 |
| CHAMOMILLA VULGARIS GRANULE 1DH - 30CH | dolisos laboratoires s.a. | 00700010 | Tablet - Oral | 1 DH / DH | 12/31/1987 |
| TEE COMPLEX DPS | thompson's homeopathic supplies ltd. | 00757403 | Drops - Oral | 3 X / X | 12/31/1987 |
| NERV EZE TAB THUNA'S | thuna herbal remedies ltd. | 00190373 | Tablet - Oral | 4 MG | 6/11/1980 |
| MEDIPLEX 670 - LIQ | mediherb inc. | 02116839 | Liquid - Oral | 8 X / ML | 12/19/1996 |
| FORMULE L8 LIQ | herbages naturbec ltée. | 00444243 | Liquid - Oral | 2 MG / ML | 12/31/1979 |
| CHAMOMILLA D30 DPS | dr reckeweg canada | 02078015 | Drops - Oral | 30 D / ML | 12/31/1994 |
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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