Overview
Dimehydrinate was first described in the literature in 1949, and patented in 1950. Early research into dimenhydrinate focused on its role as an antihistamine for urticaria; the treatment of motion sickness was an accidental discovery. Dimenhydrinate, also known as B-dimethylaminoethyl benzohydrol ether 8-chlorotheophyllinate, is indicated to prevent nausea, vomiting, and dizziness caused by motion sickness. Dimenhydrinate is a combination of Diphenhydramine and 8-chlorotheophylline in a salt form, with 53%-55.5% dried diphenhydramine, and 44%-47% died 8-chlorotheophylline. The antiemetic properties of dimenhydrinate are primarily thought to be produced by diphenhydramine's antagonism of H1 histamine receptors in the vestibular system while the excitatory effects are thought to be produced by 8-chlorotheophylline's adenosine receptor blockade. When used in large doses, dimenhydrinate has been shown to cause a "high" characterized by hallucinations, excitement, incoordination, and disorientation. Dimenhydrinate was granted FDA approval on 31 May 1972.
Indication
Dimenhydrinate is indicated for the prevention and treatment of nausea, vomiting, or vertigo of motion sickness.
Associated Conditions
- Dizziness
- Labyrinthine disorder
- Menière's Disease
- Morning Sickness
- Motion Sickness
- Nausea
- Nausea and vomiting
- Post Operative Nausea and Vomiting (PONV)
- Radiation-Induced Nausea and Vomiting
- Vertigo
- Vomiting
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/01 | Not Applicable | Not yet recruiting | Preeyaporn Jirakittidul | ||
2022/10/21 | Not Applicable | Completed | |||
2020/10/28 | Phase 3 | Completed | Jennifer Holder-Murray | ||
2014/10/01 | Phase 4 | Completed | |||
2014/04/14 | Phase 3 | Completed | Apsen Farmaceutica S.A. | ||
2013/07/01 | Phase 4 | Completed | |||
2012/03/05 | Phase 2 | Completed | |||
2008/11/17 | Not Applicable | Completed | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||
2005/07/28 | Phase 4 | Completed | St. Justine's Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Medtech Products Inc. | 63029-904 | ORAL | 25 mg in 1 1 | 9/10/2025 | |
| Medtech Products Inc. | 63029-902 | ORAL | 50 mg in 1 1 | 9/10/2025 | |
| Medtech Products Inc. | 63029-910 | ORAL | 25 mg in 1 1 | 5/6/2025 | |
| WinCo Foods, LLC | 67091-118 | ORAL | 50 mg in 1 1 | 9/23/2025 | |
| Fresenius Kabi USA, LLC | 63323-366 | INTRAMUSCULAR, INTRAVENOUS | 50 mg in 1 mL | 12/31/2019 | |
| Amerisource Bergen | 46122-536 | ORAL | 50 mg in 1 1 | 9/2/2025 | |
| Strategic Sourcing Services LLC | 70677-1087 | ORAL | 50 mg in 1 1 | 4/8/2025 |
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 |
|---|---|---|---|---|---|
| DIMENHYDRINATE TABLETS 50 mg | SIN02765P | TABLET | 50 mg | 5/9/1989 | |
| DIMENATE TABLET 50 mg | SIN03013P | TABLET | 50 mg | 6/1/1989 | |
| SW DIMENHYDRINATE SYRUP 15 mg/5 ml | SIN02790P | SYRUP | 15 mg/5 ml | 5/11/1989 | |
| APO-DIMENHYDRINATE TABLET 50 mg | SIN02519P | TABLET | 50 mg | 4/17/1989 | |
| NOVOMIN TABLET 50 mg | SIN03403P | TABLET | 50 mg | 6/16/1989 | |
| VOTMINE INJECTION 10 ML VIAL (50MG/ML) | SIN11495P | INJECTION | 50 mg/ml | 4/25/2001 | |
| MEDRINATE SYRUP 25 mg/5 ml | SIN07645P | SYRUP | 25 mg/5 ml | 1/10/1994 | |
| DIMENHYDRINATE TABLETS 50 mg | SIN02732P | TABLET | 50 mg | 5/6/1989 | |
| NOVOMIN SYRUP 15 mg/5 ml | SIN03550P | SYRUP | 15 mg/5 ml | 7/4/1989 |
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 |
|---|---|---|---|---|---|
| DIMENHYDRINATE SYR 15MG/5ML | N/A | N/A | N/A | 5/31/1984 | |
| AIRMIT TAB (TAIWAN) | N/A | N/A | N/A | 1/14/2011 | |
| DIMENHYDRINATE TAB 50MG | N/A | N/A | N/A | 5/5/1980 | |
| DIMENHYDRINATE SYRUP 15MG/5ML | N/A | synco (h.k.) limited | N/A | N/A | 6/10/1985 |
| TRIMIN TAB 50MG | N/A | N/A | N/A | 7/30/1988 | |
| UNI-HYDRIN TAB 50MG | N/A | N/A | N/A | 10/7/1991 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PHARMACY HEALTH TRAVEL SICKNESS TABLETS strip pack | 335591 | Medicine | A | 5/1/2020 | |
| DRAMAMINE dimenhydrinate 50mg tablet strip pack | 46980 | Proqualix Pty Ltd - in Administration | Medicine | A | 10/28/1993 |
| AMCAL TRAVEL SICKNESS TABLETS strip pack | 345907 | Medicine | A | 10/14/2020 | |
| TRAVACALM ORIGINAL tablet strip pack | 14864 | Medicine | A | 9/5/1991 | |
| ADIRAMEDICA TRAVEL SICKNESS TABLETS strip pack | 335590 | Medicine | A | 5/1/2020 | |
| TRAVELMED tablet blister pack | 490795 | Medicine | A | 6/4/2025 | |
| TRAVACALM ORIGINAL tablet blister pack | 78192 | Medicine | A | 4/18/2001 | |
| APOHEALTH TRAVEL SICKNESS TABLETS strip pack | 355903 | Medicine | A | 3/1/2021 | |
| BLOOMS THE CHEMIST TRAVEL SICKNESS TABLETS strip pack | 372732 | Medicine | A | 8/12/2021 | |
| CHEMISTS’ OWN TRAVEL SICKNESS TABLETS strip pack | 355893 | Medicine | A | 3/1/2021 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| TRAVEL TABS 50 MG | vita health products inc | 00605786 | Tablet - Oral | 50 MG | 12/31/1984 |
| DIMENHYDRINATE INJECTION USP 250MG/5ML (50MG/ML) | teligent ou | 02300648 | Solution - Intravenous
,
Intramuscular | 50 MG / ML | 6/26/2008 |
| TRAVELMATE-DIMENHYDRINATE TABLETS 50MG | ksl pharmaceuticals | 01958682 | Tablet - Oral | 50 MG | 12/31/1992 |
| GRAVOL SUPPOSITORIES | church & dwight canada corp | 00013609 | Suppository - Rectal | 100 MG | 12/31/1951 |
| CHILDREN'S MOTION SICKNESS LIQUID | ara-avanti rx analytics inc | 02468190 | Solution - Oral | 15 MG / 5 ML | 4/6/2018 |
| SICKNOL | bromed pharmaceuticals inc. | 02265079 | Tablet - Oral | 50 MG | N/A |
| MOTION SICKNESS TABLETS 50MG | d.c. labs limited | 02096544 | Tablet - Oral | 50 MG | 12/31/1995 |
| DRAMAMINE MOTION SICKNESS RELIEF | medtech products inc | 02505398 | Tablet (Chewable) - Oral | 50 MG | N/A |
| DIMENHYDRINATE INJECTION USP | hikma canada limited | 02428954 | Solution - Intramuscular
,
Intravenous | 50 MG / 1 ML | 1/28/2016 |
| ANTI-NAUSEANT LIQUID GELS | vita health products inc | 02493004 | Capsule - Oral | 50 MG | 8/4/2020 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| SALVARINA CAPSULAS DURAS | Laboratorios Salvat S.A. | 59120 | CÁPSULA DURA | Sin Receta | Not Commercialized |
| DIMENHIDRINATO CAFEINA NORMOGOBENS 50 MG/50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | Laboratorios Normon S.A. | 83719 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Sin Receta | Not Commercialized |
| CINFAMAR INFANTIL 12,5 mg SOLUCION ORAL | Laboratorios Cinfa S.A. | 72308 | SOLUCIÓN ORAL | Sin Receta | Commercialized |
| DIMENHIDRINATO CAFEINA GOBENS 50 MG/50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | Laboratorios Normon S.A. | 83718 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Sin Receta | Not Commercialized |
| NORMOSTOP CAFEINA 50 MG/50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | Laboratorios Normon S.A. | 83545 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Sin Receta | Commercialized |
| DIZINEL 20 MG/40 MG COMPRIMIDOS EFG | 84721 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| NORMOSTOP 50 MG COMPRIMIDOS | Laboratorios Normon S.A. | 78946 | COMPRIMIDO | Sin Receta | Commercialized |
| CINFAMAR 50 mg COMPRIMIDOS RECUBIERTOS | Laboratorios Cinfa S.A. | 60839 | COMPRIMIDO RECUBIERTO | Sin Receta | Commercialized |
| BIODRAMINA 20 mg CHICLES MEDICAMENTOSOS | Uriach Consumer Healthcare S.L. | 57681 | CHICLE MEDICAMENTOSO | Sin Receta | Commercialized |
| BIODRAMINA INFANTIL 24 MG SOLUCION ORAL | Uriach Consumer Healthcare S.L. | 76942 | SOLUCIÓN ORAL | Sin Receta | Not Commercialized |
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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