NDC 45737-261

Biocotron PED

Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Biocotron PED is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Advanced Generic Corporation. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID45737-261_36fe8315-671b-4977-9a84-20ddc65a70fc
NDC45737-261
Product TypeHuman Otc Drug
Proprietary NameBiocotron PED
Generic NameDextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2015-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAdvanced Generic Corporation
Substance NameDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength15 mg/5mL; mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 45737-261-16

473 mL in 1 BOTTLE (45737-261-16)
Marketing Start Date2015-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45737-261-16 [45737026116]

Biocotron PED LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-03-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL

OpenFDA Data

SPL SET ID:53097e28-ff2a-4ceb-9c95-d75d7ae511b8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1372451
  • UPC Code
  • 0345737261165
  • NDC Crossover Matching brand name "Biocotron PED" or generic name "Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    45737-261Biocotron PEDBiocotron PED
    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.