NDC 50594-016

Sound Body Cold and Flu Relief

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Sound Body Cold and Flu Relief is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Big Lots Stores, Inc.. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 50594-016_3e08c72c-3ee9-4382-8e58-34fef51a9f2d
• NDC: 50594-016
• Product Type: Human Otc Drug
• Proprietary Name: Sound Body Cold and Flu Relief
• Generic Name: Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2016-05-03
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Big Lots Stores, Inc.
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50594-016-40

355 mL in 1 BOTTLE (50594-016-40)

• Marketing Start Date: 2016-05-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50594-016-40 [50594001640]

Sound Body Cold and Flu Relief SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-05-03

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	325 mg/15mL

OpenFDA Data

• SPL SET ID: cf5ed024-42be-433a-b898-3fa547aa14fe
• Manufacturer:
  • Big Lots Stores, Inc.
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1369842

NDC Crossover Matching brand name "Sound Body Cold and Flu Relief" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
50594-335	sound body cold and flu relief	sound body cold and flu relief
50594-027	sound body cold and flu relief	sound body cold and flu relief
50594-459	sound body cold and flu relief	sound body cold and flu relief
50594-016	Sound Body Cold and Flu Relief	Sound Body Cold and Flu Relief
0113-7603	Basic Care Daytime Cold and Flu Severe	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0113-7303	basic care mucus relief cold flu and sore throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0640	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0299	good sense cold and flu severe	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0234	good sense cold head congestion	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0381	Good Sense Mucus Relief	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-1913	good sense mucus relief cold flu and sore throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0579	good sense severe cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0548	Good Sense Severe Daytime	acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
0113-0603	Good Sense Severe Daytime Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0113-9007	Good Sense Severe Tussin CF Max	Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
0363-0616	Mucus Relief	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0538	Mucus Relief Cold Flu Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0719	Mucus Relief Cold Flu Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0372	Mucus Relief Plus	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0410	Mucus Relief Severe Cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0503	Severe Cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0603	Severe Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0363-0524	Sinus Relief	Acetaminophen, Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl
0067-8145	Theraflu ExpressMax Severe Cold and Flu Caplets	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0067-8132	Theraflu ExpressMax Severe Cold and Flu Syrup	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0051	Wal Tussin CF Max	Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl