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 ID: 62583-003_28da3c14-2798-5d2f-e054-00144ff88e88
• NDC: 62583-003
• Product Type: Human Otc Drug
• Proprietary Name: Xpecto soothing relief
• Generic Name: Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2016-05-09
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: BRONCOLIN, S.A. de C.V.
• Substance Name: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
• Active Ingredient Strength: 200 mg/10mL; mg/10mL; mg/10mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 62583-003-14

118 mL in 1 BOTTLE (62583-003-14)

• Marketing Start Date: 2016-05-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62583-003-14 [62583000314]

Xpecto soothing relief SYRUP

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-05-09
• Marketing End Date: 2019-12-02

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	200 mg/10mL

OpenFDA Data

• SPL SET ID: 28da3c14-2797-5d2f-e054-00144ff88e88
• Manufacturer:
  • BRONCOLIN, S.A. de C.V.
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1604325

NDC Crossover Matching brand name "Xpecto soothing relief" or generic name "Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl"

NDC	Brand Name	Generic Name
62583-003	Xpecto	Dextromethorphan HBr Guaifenesin Phenylephrine HCl
76095-005	Xpecto	Dextromethorphan HBr Guaifenesin Phenylephrine HCl