Home NDC 68016-598-16 Daytime Cold and Flu Relief
Product NDC 68016-598
Requested package NDC 68016-598-16
11-digit product format 680160598
Labeler code 68016
Product ID 68016-598_45d379fb-5791-e3d5-6a99-951d923ff3e6
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Chain Drug Consortium, LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-10-12
Marketing end 2021-07-30
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 0000-00-00
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 DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DAYTIME COLD AND FLU RELIEF NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE ) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-598-16 68016059816 2 BLISTER PACK in 1 CARTON (68016-598-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2015-10-12 2021-07-30 No No Current