MedPath

Chamomile

Generic Name
Chamomile
Drug Type
Biotech
Unique Ingredient Identifier
FGL3685T2X

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

Published: Oct 21, 2025

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

Continue reading the full research report

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.

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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