Home NDC 50594-014 Sound Body Cold and Flu Relief
Product NDC 50594-014
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50594-014-62 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50594-014-62 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50594-014-62 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50594-014-62 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50594-014-62 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50594-014-62 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50594-014-62 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50594-014-62 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50594-014-62 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 GELATIN INACTIVE INGREDIENT 2G86QN327L SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 POVIDONES INACTIVE INGREDIENT FZ989GH94E SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 14 WATER INACTIVE INGREDIENT 059QF0KO0R SOUND 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 NDC Dashboard title SPL version Validation Dashboard ZIP 50594-014 SOUND BODY COLD AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [BIG LOTS STORES, INC.] 17 Legacy NDC 20191119_5528e1a1-ed0e-4afd-bcc9-c72b1b50e465.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50594-014-62 50594001462 12 BLISTER PACK in 1 CARTON (50594-014-62) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 12 blister pack 2015-10-15 0000-00-00 No No Current