NDC 0031-8762

Childrens Robitussin Honey Nighttime Cough DM

Dextromethorphan Hbr, Doxylamine Succinate

Childrens Robitussin Honey Nighttime Cough DM is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Dextromethorphan Hydrobromide; Doxylamine Succinate.

Product ID0031-8762_0090f49b-0d0f-4e22-a87c-beeb511b0df6
NDC0031-8762
Product TypeHuman Otc Drug
Proprietary NameChildrens Robitussin Honey Nighttime Cough DM
Generic NameDextromethorphan Hbr, Doxylamine Succinate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-05-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active Ingredient Strength15 mg/10mL; mg/10mL
Pharm ClassesAntihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0031-8762-12

1 BOTTLE in 1 CARTON (0031-8762-12) > 118 mL in 1 BOTTLE
Marketing Start Date2019-05-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0031-8762-12 [00031876212]

Childrens Robitussin Honey Nighttime Cough DM SOLUTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-05-27

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/10mL

OpenFDA Data

SPL SET ID:6afaf85b-bf0c-4c99-acf3-a34f06be20f1
Manufacturer
UNII

NDC Crossover Matching brand name "Childrens Robitussin Honey Nighttime Cough DM" or generic name "Dextromethorphan Hbr, Doxylamine Succinate"

NDCBrand NameGeneric Name
0031-8762Childrens Robitussin Honey Nighttime Cough DMdextromethorphan hbr, doxylamine succinate
41520-995CareOne NightTime CoughDextromethorphan HBr, Doxylamine succinate
41520-523CareOne Tussin DMdextromethorphan hbr, doxylamine succinate
41520-826careone tussin dmDextromethorphan HBr, Doxylamine succinate
0363-0019CoughDextromethorphan HBr, Doxylamine succinate
42507-800coughDextromethorphan HBr, Doxylamine succinate
41163-551equaline nighttime cough reliefDextromethorphan HBr, Doxylamine succinate
46122-375Good Neighbor Pharmacy Tussin DM MAXdextromethorphan hbr, doxylamine succinate
46122-542good neighbor pharmacy tussin dm maxDextromethorphan HBr, Doxylamine succinate
37808-668night timeDextromethorphan HBr, Doxylamine succinate
50844-043Nighttime Cough DMDextromethorphan HBr, Doxylamine Succinate
55319-043Nighttime Cough DMDextromethorphan HBr, Doxylamine Succinate
11822-0668nighttime cough reliefDextromethorphan HBr, Doxylamine succinate
37012-668Nighttime Cough ReliefDextromethorphan HBr, Doxylamine succinate
0363-0444Nighttime Daytime Coughdextromethorphan HBr, doxylamine succinate
0031-8758Robitussin Honey Maximum Strength Nighttime Cough DMdextromethorphan HBr, doxylamine succinate
41190-668ShopRite Ni CalmDextromethorphan HBr, Doxylamine succinate
36800-511TopCare Tussin DMdextromethorphan hbr, doxylamine succinate
36800-841topcare tussin dm maxdextromethorphan hbr, doxylamine succinate
49580-0414Tussin DM CoughDextromethorphan HBr, Doxylamine succinate
49035-943Tussin DM MaxDextromethorphan HBr, Doxylamine Succinate
11673-695Up and Up nighttime cough controldextromethorphan hbr, doxylamine succinate
11673-719up and up nighttime cough control dm maxDextromethorphan HBr, Doxylamine succinate
0363-0758Walgreens Adult Nighttime Wal Tussin DM Max Maximum StrengthDextromethorphan HBr, Doxylamine succinate

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