NDC 62583-003

Xpecto soothing relief

Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl

Xpecto soothing relief is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Broncolin, S.a. De C.v.. The primary component is Guaifenesin; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID62583-003_28da3c14-2798-5d2f-e054-00144ff88e88
NDC62583-003
Product TypeHuman Otc Drug
Proprietary NameXpecto soothing relief
Generic NameDextromethorphan Hbr Guaifenesin Phenylephrine Hcl
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2016-05-09
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameBRONCOLIN, S.A. de C.V.
Substance NameGUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength200 mg/10mL; mg/10mL; mg/10mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 62583-003-14

118 mL in 1 BOTTLE (62583-003-14)
Marketing Start Date2016-05-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62583-003-14 [62583000314]

Xpecto soothing relief SYRUP
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-05-09
Marketing End Date2019-12-02

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN200 mg/10mL

OpenFDA Data

SPL SET ID:28da3c14-2797-5d2f-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1604325
  • NDC Crossover Matching brand name "Xpecto soothing relief" or generic name "Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    62583-003XpectoDextromethorphan HBr Guaifenesin Phenylephrine HCl
    76095-005XpectoDextromethorphan HBr Guaifenesin Phenylephrine HCl

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