Home NDC 0904-5783 Mapap Sinus Congestion and Pain
Product NDC 0904-5783
11-digit product format 009045783
Labeler code 0904
Product ID 0904-5783_cf18dff8-d719-47a9-83ae-3d36b5a4d0c2
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Major Pharmaceuticals
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2005-07-26
Marketing end 2021-11-15
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0904-5783-24 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0904-5783-24 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0904-5783-24 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0904-5783-24 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0904-5783-24 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0904-5783-24 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0904-5783-24 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0904-5783-24 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0904-5783-24 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0904-5783-24 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0904-5783-24 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0904-5783-24 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 MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MAPAP SINUS CONGESTION AND PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-5783-24 00904578324 2 BLISTER PACK in 1 CARTON (0904-5783-24) > 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-07-26 2021-11-15 No No Current