Home NDC 55319-468-16 Non-Drowsy Daytime Multi Symptom Cold and Flu Relief
Product NDC 55319-468
Requested package NDC 55319-468-16
11-digit product format 553190468
Labeler code 55319
Product ID 55319-468_f414cc41-8ffd-48f4-be4e-775c53d59931
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-10-31
Marketing end 2024-07-26
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 · 11 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…
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 NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 CARMINIC ACID INACTIVE INGREDIENT CID8Z8N95N NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 SODIUM METABISULFITE INACTIVE INGREDIENT 4VON5FNS3C NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NON-DROWSY DAYTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55319-468-16 55319046816 16 BLISTER PACK in 1 CARTON (55319-468-16) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 16 blister pack 2015-10-31 2024-07-26 No No Current