NDC 58809-391

TEXACLEAR DAYTIME COUGH COLD/FLU

Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

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

• Product ID: 58809-391_45d3fc9b-1ec2-4c07-9ab0-5cecdc16390d
• NDC: 58809-391
• Product Type: Human Otc Drug
• Proprietary Name: TEXACLEAR DAYTIME COUGH COLD/FLU
• Generic Name: Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2014-10-21
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: GM Pharmaceuticals, INC
• Substance Name: CHOLINE SALICYLATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
• Active Ingredient Strength: 870 mg/30mL; mg/30mL; mg/30mL; mg/30mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 58809-391-08

237 mL in 1 BOTTLE, PLASTIC (58809-391-08)

• Marketing Start Date: 2014-10-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58809-391-08 [58809039108]

TEXACLEAR DAYTIME COUGH COLD/FLU LIQUID

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-10-21

Drug Details

Active Ingredients

Ingredient	Strength
CHOLINE SALICYLATE	870 mg/30mL

OpenFDA Data

• SPL SET ID: 179f63a0-0f35-0c8d-e054-00144ff88e88
• Manufacturer:
  • GM Pharmaceuticals, INC
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • KD510K1IQW
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1653134
• UPC Code:
  • 0358809391080

NDC Crossover Matching brand name "TEXACLEAR DAYTIME COUGH COLD/FLU" or generic name "Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
58809-391	TEXACLEAR DAYTIME COUGH COLD/FLU	Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
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
36800-777	TOPCARE COUGH COLD AND FLU SIMPLE RELIEF	CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE