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Doxylamine

Generic Name
Doxylamine
Brand Names
Bonjesta, Dalmacol, Dayquil Sinex, Diclectin, Diclegis, Mersyndol, Nyquil Cough, Poly Hist Forte Reformulated Nov 2013, Robafen DM, Robitussin Nighttime Cough DM, Safetussin PM, Unisom, Wal-som (doxylamine)
Drug Type
Small Molecule
Chemical Formula
C17H22N2O
CAS Number
469-21-6
Unique Ingredient Identifier
95QB77JKPL

Overview

Histamine H1 antagonist with pronounced sedative properties. It is used in allergies and as an antitussive, antiemetic, and hypnotic. Doxylamine has also been administered in veterinary applications and was formerly used in parkinsonism.

Indication

用于枯草热、过敏性鼻炎,短期用于失眠。

Associated Conditions

  • Common Cold
  • Insomnia
  • Mild Allergic Rhinitis
  • Nausea
  • Symptoms Flu
  • Vomiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
BI-MART
37835-525
ORAL
12.5 mg in 30 mL
5/1/2025
NUVICARE LLC
84324-019
ORAL
6.25 mg in 1 1
5/20/2025
Publix Super Markets Inc
56062-763
ORAL
12.5 mg in 30 mL
5/19/2025
Mylan Pharmaceuticals Inc.
0378-4615
ORAL
10 mg in 1 1
1/3/2019
CVS Pharmacy
69842-899
ORAL
6.25 mg in 1 1
6/18/2025
Lil' Drug Store Products, Inc.
66715-6805
ORAL
6.25 mg in 1 1
6/17/2025
Bryant Ranch Prepack
72162-1485
ORAL
10 mg in 1 1
10/14/2020
Bionpharma Inc.,
69452-206
ORAL
10 mg in 1 1
12/11/2023
Topco Associates LLC
76162-603
ORAL
25 mg in 1 1
3/26/2025
Actavis Pharma, Inc.
0591-2132
ORAL
10 mg in 1 1
10/24/2023

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
DICLECTIN DELAYED RELEASE TABLETS 10MG/10MG
SIN15301P
TABLET, DELAYED RELEASE
10mg
7/20/2017
BONJESTA EXTENDED-RELEASE TABLETS 20 MG/20 MG
SIN16865P
TABLET, FILM COATED, EXTENDED RELEASE
20.0mg
9/18/2023

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.

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