Home NDC 55319-316-08 Daytime Severe Cold and Cough Relief
Product NDC 55319-316
Requested package NDC 55319-316-08
11-digit product format 553190316
Labeler code 55319
Product ID 55319-316_12262853-036d-418b-9a8e-ce5bc471333a
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL
Dosage form LIQUID
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-08-31
Marketing end 2021-12-30
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650 mg/30mL; mg/30mL; mg/30mL
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 SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 MALTITOL INACTIVE INGREDIENT D65DG142WK DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DAYTIME SEVERE COLD AND COUGH RELIEF (ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [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 55319-316-08 55319031608 245 mL in 1 BOTTLE, PLASTIC (55319-316-08) 245 ml 2015-08-31 2021-12-30 No No Current