NDC 41520-384

CareOne Cough DM

Dextromethorphan Polistirex

CareOne Cough DM is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by American Sales Company. The primary component is Dextromethorphan Hydrobromide.

Product ID41520-384_be7ee945-e06a-434e-ad15-30e6d16591c4
NDC41520-384
Product TypeHuman Otc Drug
Proprietary NameCareOne Cough DM
Generic NameDextromethorphan Polistirex
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2012-08-30
Marketing CategoryANDA / ANDA
Application NumberANDA091135
Labeler NameAmerican Sales Company
Substance NameDEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength30 mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 41520-384-21

1 BOTTLE in 1 CARTON (41520-384-21) > 89 mL in 1 BOTTLE
Marketing Start Date2012-08-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 41520-384-21 [41520038421]

CareOne Cough DM SUSPENSION
Marketing CategoryANDA
Application NumberANDA091135
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-08-30

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

OpenFDA Data

SPL SET ID:2543912b-e6dd-46ca-8f0e-12603f6c28a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1373045
  • NDC Crossover Matching brand name "CareOne Cough DM" or generic name "Dextromethorphan Polistirex"

    NDCBrand NameGeneric Name
    41520-384CareOne Cough DMCareOne Cough DM
    41520-958CareOne Cough DMCareOne Cough DM
    0113-7384basic care cough DMdextromethorphan polistirex
    0363-0899childrens cough dmDextromethorphan polistirex
    0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0363-0384Cough DMdextromethorphan polistirex
    0363-0494Cough DMdextromethorphan polistirex
    0363-0958Cough DMdextromethorphan polistirex
    0904-6312cough dmdextromethorphan polistirex
    11822-0384Cough DMdextromethorphan polistirex
    11822-0494Cough DMdextromethorphan polistirex
    0113-0384good sense cough dmdextromethorphan polistirex
    0113-0958Good Sense Cough DMdextromethorphan polistirex
    0031-8655Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8753Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8754Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    0031-8755Robitussin 12 Hour Cough Reliefdextromethorphan polistirex
    11673-114up and up 12 hour cough reliefdextromethorphan polistirex

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