Home NDC 55315-047-08 Cold Head Congestion Daytime
Product NDC 55315-047
Requested package NDC 55315-047-08
11-digit product format 553150047
Labeler code 55315
Product ID 55315-047_f5ea5552-39ae-4f54-8313-1a5fffd9ea49
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler FRED'S, INC.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2005-07-15
Marketing end 2022-08-22
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COLD HEAD CONGESTION DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [FRED'S, 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 55315-047-08 55315004708 2 BLISTER PACK in 1 BOX (55315-047-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-07-15 2022-08-22 No No Current