NDC 36800-788

topcare tussin dm max

Dextromethorphan Hydrobromide, Doxylamine Succinate

topcare tussin dm max is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID36800-788_7b6e8eee-a3b5-4083-9f44-eb9bd661eac2
NDC36800-788
Product TypeHuman Otc Drug
Proprietary Nametopcare tussin dm max
Generic NameDextromethorphan Hydrobromide, Doxylamine Succinate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-05-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTopco Associates LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength30 mg/20mL; mg/20mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-788-26

1 BOTTLE in 1 CARTON (36800-788-26) > 118 mL in 1 BOTTLE
Marketing Start Date2019-05-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-788-26 [36800078826]

topcare tussin dm max SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-02

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/20mL

OpenFDA Data

SPL SET ID:e1118592-30ac-4505-9f38-c6d395c4cf5b
Manufacturer
UNII

NDC Crossover Matching brand name "topcare tussin dm max" or generic name "Dextromethorphan Hydrobromide, Doxylamine Succinate"

NDCBrand NameGeneric Name
36800-788topcare tussin dm maxDextromethorphan hydrobromide, Doxylamine succinate
36800-799Topcare Tussin DM MaxDextromethorphan HBr, Guaifenesin
36800-841topcare tussin dm maxdextromethorphan hbr, doxylamine succinate
36800-847topcare tussin dm maxDextromethorphan HBr, Guaifenesin
49035-209Equate Nightime Coughdextromethorphan hydrobromide, doxylamine succinate
49035-668Equate Nite TimeDextromethorphan Hydrobromide, Doxylamine Succinate
24385-461Good Neighbor Pharmacy night timeDextromethorphan Hydrobromide, Doxylamine Succinate
0113-0668Good Sense Nighttime CoughDextromethorphan Hydrobromide, Doxylamine Succinate
41250-758meijer Maximum Strength Nighttime Cough DMdextromethorphan hydrobromide, doxylamine succinate
15127-881Night Time CoughDextromethorphan Hydrobromide, Doxylamine Succinate
21130-345Night Time CoughDextromethorphan Hydrobromide, Doxylamine Succinate
21130-499Night Time CoughDextromethorphan Hydrobromide, Doxylamine Succinate
49580-0499Night Time CoughDextromethorphan Hydrobromide, Doxylamine Succinate
53943-508Night-TimeDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
30142-668NightTime CoughDextromethorphan Hydrobromide, Doxylamine Succinate
42507-668Nighttime CoughDextromethorphan Hydrobromide, Doxylamine Succinate
49580-0345Nighttime CoughDextromethorphan Hydrobromide, Doxylamine Succinate
11822-6960nighttime cough dm maxDextromethorphan Hydrobromide, Doxylamine succinate
41250-668Nitetime CoughDextromethorphan Hydrobromide, Doxylamine Succinate
41250-031NiteTime Cough DayTime Coughdextromethorphan hydrobromide, doxylamine succinate
0031-8718Robitussin Maximum Strength Nighttime Cough DMdextromethorphan hydrobromide, doxylamine succinate
49738-668smart sense nighttime coughDextromethorphan Hydrobromide, Doxylamine Succinate
36800-668topcare nite timeDextromethorphan Hydrobromide, Doxylamine Succinate

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.