NDC 63868-447

Long Acting Cough Softgels

Dextromethorphan Hbr

Long Acting Cough Softgels is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Chain Drug Marketing Association Inc. The primary component is Dextromethorphan Hydrobromide.

Product ID63868-447_12f41adc-7194-4324-94d0-38e7b9b96662
NDC63868-447
Product TypeHuman Otc Drug
Proprietary NameLong Acting Cough Softgels
Generic NameDextromethorphan Hbr
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2019-08-07
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameCHAIN DRUG MARKETING ASSOCIATION INC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength15 mg/1
Pharm ClassesSigma-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 63868-447-20

1 BOTTLE, PLASTIC in 1 CARTON (63868-447-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
Marketing Start Date2019-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63868-447-20 [63868044720]

Long Acting Cough Softgels CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-07

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1

OpenFDA Data

SPL SET ID:7323acdb-cc86-4653-b9ba-675bd82dfe52
Manufacturer
UNII
UPC Code
  • 0635515996120
  • NDC Crossover Matching brand name "Long Acting Cough Softgels" or generic name "Dextromethorphan Hbr"

    NDCBrand NameGeneric Name
    63868-447Long Acting Cough SoftgelsLong Acting Cough Softgels
    63868-345Long Acting Cough SoftgelsLong Acting Cough Softgels
    21130-383Adult Cough Relief DMDextromethorphan HBr
    0363-0500CoughDextromethorphan HBr
    15127-661Cough ControlDextromethorphan HBr
    0363-8990Cough ReliefDEXTROMETHORPHAN HBr
    15127-309Cough ReliefDextromethorphan HBr
    24385-262Cough ReliefDextromethorphan HBr
    24385-263Cough ReliefDextromethorphan HBr
    33992-0666Cough ReliefDextromethorphan HBr
    36800-454Cough ReliefDextromethorphan HBr
    36800-509Cough ReliefDextromethorphan HBr
    0536-1323Dextromethorphan HBrDextromethorphan HBr
    0536-1334Dextromethorphan HBr 15 mg Liquid GelsDextromethorphan HBr
    0395-9126Father Johns MedicineDextromethorphan HBr
    0536-1068Robafen CoughDextromethorphan HBr
    0031-8741ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELSdextromethorphan HBr
    21130-635Signature Care Daytime CoughDextromethorphan HBr
    0363-6610Wal-TussinDextromethorphan HBr

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