Home NDC 55316-580-72 Healthy Accents Daytime Nighttime Cold and Flu
Product NDC 55316-580
Requested package NDC 55316-580-72
11-digit product format 553160580
Labeler code 55316
Product ID 55316-580_8aaaee55-a18b-47f3-8a0c-9373db622003
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
Dosage form KIT
Labeler DZA Brands LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-05-30
Marketing end 0000-00-00
Active strength 0
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R HEALTHY ACCENTS DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [DZA BRANDS LLC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55316-580-72 55316058072 1 KIT in 1 CARTON (55316-580-72) * 16 BLISTER PACK in 1 CARTON > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 8 BLISTER PACK in 1 CARTON > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK 1 kit 2014-05-30 0000-00-00 No No Current