NDC 58809-413

DayClear COUGH COLD AND FLU

Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

DayClear COUGH COLD AND FLU is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gm Pharmaceuticals, Inc. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride; Choline Salicylate.

• Product ID: 58809-413_0f6080ae-73ea-4a6c-8b07-1e687fb131fd
• NDC: 58809-413
• Product Type: Human Otc Drug
• Proprietary Name: DayClear COUGH COLD AND FLU
• Generic Name: Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2015-10-20
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: GM Pharmaceuticals, INC
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; CHOLINE SALICYLATE
• Active Ingredient Strength: 20 mg/30mL; mg/30mL; mg/30mL; mg/30mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 58809-413-08

237 mL in 1 BOTTLE (58809-413-08)

• Marketing Start Date: 2015-10-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58809-413-08 [58809041308]

DayClear COUGH COLD AND FLU LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-10-20
• Marketing End Date: 2019-06-07

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/30mL

OpenFDA Data

• SPL SET ID: 349eb2ab-f209-2c66-e054-00144ff8d46c
• Manufacturer:
  • GM Pharmaceuticals, INC
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • KD510K1IQW
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1653134
• UPC Code:
  • 0358809413089

NDC Crossover Matching brand name "DayClear COUGH COLD AND FLU" or generic name "Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
58809-413	DayClear COUGH COLD AND FLU	Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
30142-771	Kroger Cough Cold and Flu	Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
58809-391	TEXACLEAR DAYTIME COUGH COLD/FLU	Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
36800-777	TOPCARE COUGH COLD AND FLU SIMPLE RELIEF	CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE