Home NDC 55315-066-12 Cold and Flu
Product NDC 55315-066
Requested package NDC 55315-066-12
11-digit product format 553150066
Labeler code 55315
Product ID 55315-066_98097347-e488-4acd-9bc1-d50a4d0eb7fe
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form LIQUID
Route ORAL
Labeler Freds Inc
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-07-31
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/15mL; mg/15mL; mg/15mL
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 I Inactivated by FDA bd6a592717d7…303034d00443…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE COLD AND FLU DAYTIME RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [FREDS INC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55315-066-12 55315006612 355 mL in 1 BOTTLE, PLASTIC (55315-066-12) 355 ml 2015-07-31 0000-00-00 No No Current