Sound Body Cold and Flu Relief

Product NDC
50594-014
Requested package NDC
50594-014-62
11-digit product format
505940014
Labeler code
50594
Product ID
50594-014_8af06f97-a644-487d-961a-4d2345fa03fd
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Big Lots Stores, Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-10-15
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/1; mg/1; mg/1
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50594-01450594-014-62DDiscontinued by firm2026-08-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50594-014-622025-01-30C16284748780-12cef2736-7373-d83d-e063-dadaa90ab31fBig Lots, Inc Cold & Flu Relief Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
GELATININACTIVE INGREDIENT2G86QN327LSOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
POVIDONESINACTIVE INGREDIENTFZ989GH94ESOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14
WATERINACTIVE INGREDIENT059QF0KO0RSOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50594-014SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.]17Legacy NDC20191119_5528e1a1-ed0e-4afd-bcc9-c72b1b50e465.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50594-014-625059400146212 BLISTER PACK in 1 CARTON (50594-014-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK12 blister pack2015-10-150000-00-00NoNoCurrent