Nuedexta

Active substance: dextromethorphan, quinidine

dextromethorphan, quinidine

Centralised EU authorisationWithdrawn

Marketing holder: Jenson Pharmaceutical Services Limited

Verified 2026-10-09 · EMA

Analogues in other countries

Source: EMA
Countries with the substance registered: 3

Composition

Products containing dextromethorphan in other countries

Showing products with this active substance, combinations included; the full composition is shown for each product.

Country	Products
RU 12	ГРИППЕКС® таблетки, 10 мг+325 мг+30 мг (original in Russian, GRLS) ЛП-№(015900)-(РГ-RU) Юнифарм Инк ГРИППЕКС® таблетки, 10 мг+325 мг+30 мг (original in Russian, GRLS) ЛС-000891 Юнифарм Инк Каффетин® Колд таблетки, покрытые пленочной оболочкой, ~ (original in Russian, GRLS) ЛП-№(009714)-(РГ-RU) АЛКАЛОИД АД Скопье Каффетин® Колд таблетки, покрытые пленочной оболочкой, ~ (original in Russian, GRLS) ЛСР-006775/09 АЛКАЛОИД АД Скопье ТОФФ ПЛЮС капсулы, 15 мг+500 мг+10 мг+2 мг (original in Russian, GRLS) ЛП-№(006968)-(РГ-RU) Панацея Биотек Фарма Лтд. All products in this country (12)
US 2002	12 HR RELIEF COUGH DM SUSPENSION · DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 51316-263 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 12 hr relief cough dm SUSPENSION, EXTENDED RELEASE · DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL 51316-943 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 7 Select Maximum Strength SOLUTION · DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL, GUAIFENESIN 400 mg/20mL 10202-740 7-ELEVEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE CAPSULE, LIQUID FILLED · PHENYLEPHRINE HYDROCHLORIDE 5 mg/1, ACETAMINOPHEN 325 mg/1, DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1, DOXYLAMINE SUCCINATE 6.25 mg/1 14803-907 Elysium Pharmaceuticals Ltd ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL CAPSULE, LIQUID FILLED · PHENYLEPHRINE HYDROCHLORIDE 5 mg/1, ACETAMINOPHEN 325 mg/1, DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1, GUAIFENESIN 200 mg/1 41226-628 Kroger Company All products in this country (2002)

Country

Products

RU 12

ГРИППЕКС®
таблетки, 10 мг+325 мг+30 мг (original in Russian, GRLS)
ЛП-№(015900)-(РГ-RU)
Юнифарм Инк
ГРИППЕКС®
таблетки, 10 мг+325 мг+30 мг (original in Russian, GRLS)
ЛС-000891
Юнифарм Инк
Каффетин® Колд
таблетки, покрытые пленочной оболочкой, ~ (original in Russian, GRLS)
ЛП-№(009714)-(РГ-RU)
АЛКАЛОИД АД Скопье
Каффетин® Колд
таблетки, покрытые пленочной оболочкой, ~ (original in Russian, GRLS)
ЛСР-006775/09
АЛКАЛОИД АД Скопье
ТОФФ ПЛЮС
капсулы, 15 мг+500 мг+10 мг+2 мг (original in Russian, GRLS)
ЛП-№(006968)-(РГ-RU)
Панацея Биотек Фарма Лтд.

All products in this country (12)

US 2002

12 HR RELIEF COUGH DM
SUSPENSION · DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL
51316-263
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
12 hr relief cough dm
SUSPENSION, EXTENDED RELEASE · DEXTROMETHORPHAN HYDROBROMIDE 30 mg/5mL
51316-943
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
7 Select Maximum Strength
SOLUTION · DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL, GUAIFENESIN 400 mg/20mL
10202-740
7-ELEVEN
ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE
CAPSULE, LIQUID FILLED · PHENYLEPHRINE HYDROCHLORIDE 5 mg/1, ACETAMINOPHEN 325 mg/1, DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1, DOXYLAMINE SUCCINATE 6.25 mg/1
14803-907
Elysium Pharmaceuticals Ltd
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCL
CAPSULE, LIQUID FILLED · PHENYLEPHRINE HYDROCHLORIDE 5 mg/1, ACETAMINOPHEN 325 mg/1, DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1, GUAIFENESIN 200 mg/1
41226-628
Kroger Company

All products in this country (2002)

Registration

Registration number: EMEA/H/C/002560
Registration status: Withdrawn
ATC code: N07XX59

Sources

product · EMA · EMEA/H/C/002560 · Verified 2026-10-09
registration_status · EMA · EMEA/H/C/002560 · Verified 2026-10-09
ingredients.0 · EMA · EMEA/H/C/002560 · Verified 2026-10-09
ingredients.1 · EMA · EMEA/H/C/002560 · Verified 2026-10-09