Sound Body Cold and Flu Relief

Product NDC: 50594-016
11-digit product format: 505940016
Labeler code: 50594
Product ID: 50594-016_3e08c72c-3ee9-4382-8e58-34fef51a9f2d
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Dosage form: SOLUTION
Route: ORAL
Labeler: Big Lots Stores, Inc.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2016-05-03
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50594-016		D	Discontinued by firm		2026-07-31
excluded package	package	50594-016	50594-016-40	D	Discontinued by firm		2026-07-31

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50594-016	SOUND BODY COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [BIG LOTS STORES, INC.]	5	Legacy NDC	20241108_cf5ed024-42be-433a-b898-3fa547aa14fe.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50594-016-40	50594001640	355 mL in 1 BOTTLE (50594-016-40)	355 ml	2016-05-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Big Lots, Inc. DayTime Cold & Flu NightTime Cold & Flu Drug Facts	Big Lots Stores, Inc.	2024-12-14	HUMAN OTC DRUG LABEL	3
Big Lots, Inc Cold & Flu Relief Drug Facts	Big Lots Stores, Inc.	2024-11-06	HUMAN OTC DRUG LABEL	5