Home NDC 55315-455-08 Sinus Congestion and Pain
Product NDC 55315-455
Requested package NDC 55315-455-08
11-digit product format 553150455
Labeler code 55315
Product ID 55315-455_67cc48fe-20e8-46a8-a2ee-9cef66226f7d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Chlorpheniramine Maleate and Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler FRED'S, INC.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2005-06-28
Marketing end 2022-04-08
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; 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 SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SINUS CONGESTION AND PAIN NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL) TABLET, FILM COATED [FRED'S, INC.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55315-455-08 55315045508 2 BLISTER PACK in 1 CARTON (55315-455-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-06-28 2022-04-08 No No Current