NDC 50844-004

Severe Congestion and Cough Relief Maximum Strength

Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Severe Congestion and Cough Relief Maximum Strength is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by L.n.k. International, Inc.. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID50844-004_05174cca-a5fe-4de9-a968-8f9387699e2d
NDC50844-004
Product TypeHuman Otc Drug
Proprietary NameSevere Congestion and Cough Relief Maximum Strength
Generic NameDextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2017-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameL.N.K. International, Inc.
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength20 mg/20mL; mg/20mL; mg/20mL
Pharm ClassesAdrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50844-004-45

177 mL in 1 BOTTLE (50844-004-45)
Marketing Start Date2017-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50844-004-45 [50844000445]

Severe Congestion and Cough Relief Maximum Strength LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL

OpenFDA Data

SPL SET ID:8141ddc5-2a25-4800-a465-58d3b45bceb0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1043543
  • UPC Code
  • 0350844004451
  • NDC Crossover Matching brand name "Severe Congestion and Cough Relief Maximum Strength" or generic name "Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    50844-004Severe Congestion and Cough Relief Maximum StrengthSevere Congestion and Cough Relief Maximum Strength
    11026-2780Broncotron PEDDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    11026-2790Broncotron PEDDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    30142-839Childrens Mucus Reliefdextromethorphan HBr, guaifenesin, phenylephrine HCl
    11822-0839childrens mucus relief multi symptom colddextromethorphan HBr, guaifenesin, phenylephrine HCl
    0363-9839childrens multi symptom colddextromethorphan HBr, guaifenesin, phenylephrine HCl
    41163-839equaline childrens mucus reliefdextromethorphan HBr, guaifenesin, phenylephrine HCl
    0113-0839Good Sense Childrens Mucus Reliefdextromethorphan HBr, guaifenesin, phenylephrine HCl
    0113-0296good sense tussindextromethorphan hbr, guaifenesin, phenylephrine hcl
    37808-407Mucus Multi Symptom Cold ReliefDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    41250-137Mucus ReliefDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-6480Mucus Relief Severe Congestion and CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    11822-3370Mucus Relief Severe Congestion and CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCL
    11822-3722Mucus Relief Severe Congestion and CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCL
    36800-037Mucus Relief Severe Congestion and CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    41163-047Mucus Relief Severe Congestion and CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    41163-037Mucus Relief Severe Congestion CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-6048Severe Congestion and CoughDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    21130-817Severe Congestion and Cough ReliefDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    21130-272Signature Care Childrens Multi Symptom Colddextromethorphan HBr, guaifenesin, phenylephrine HCl
    36800-839topcare childrens mucus relief multi symptom colddextromethorphan HBr, guaifenesin, phenylephrine HCl
    36800-220Topcare mucus reliefDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    36800-296topcare tussin cf maxdextromethorphan hbr, guaifenesin, phenylephrine hcl
    15127-412Tussin CFDextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    11673-747Up and Up mucus relief severe congestion and coughDextromethorphan HBr, Guaifenesin, Phenylephrine HCl

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