NDC 76095-005

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 Midway Importing Inc. The primary component is Guaifenesin; Phenylephrine Hydrochloride; Dextromethorphan Hydrobromide.

Product ID76095-005_56f6be31-6fc4-092d-e054-00144ff8d46c
NDC76095-005
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 NameMIDWAY IMPORTING INC
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 76095-005-14

118 mL in 1 BOTTLE (76095-005-14)
Marketing Start Date2016-05-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76095-005-14 [76095000514]

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

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN200 mg/10mL

OpenFDA Data

SPL SET ID:33231341-1aad-2dad-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1604325
  • UPC Code
  • 0714706909900
  • 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

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