NDC 53807-531

Cough Formula Cough and Cold

Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Cough Formula Cough and Cold is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Rij Pharmaceutical Corporation. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID53807-531_26d5423d-de99-40e4-b2b1-b027c1b2519b
NDC53807-531
Product TypeHuman Otc Drug
Proprietary NameCough Formula Cough and Cold
Generic NameDextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date1999-03-16
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRij Pharmaceutical Corporation
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53807-531-08

236 mL in 1 BOTTLE (53807-531-08)
Marketing Start Date1999-03-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53807-531-08 [53807053108]

Cough Formula Cough and Cold LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date1999-03-16
Inactivation Date2020-01-31

NDC 53807-531-04 [53807053104]

Cough Formula Cough and Cold LIQUID
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date1999-03-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL

OpenFDA Data

SPL SET ID:f04c8865-e9a8-4bd2-a20c-eef2a230e0d6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1044949
  • UPC Code
  • 0353807531049
  • NDC Crossover Matching brand name "Cough Formula Cough and Cold" or generic name "Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    53807-531Cough Formula Cough and ColdCough Formula Cough and Cold
    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

    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.