Home NDC 50580-546-50 Sudafed PE Congestion
Product NDC 50580-546
Requested package NDC 50580-546-50
11-digit product format 505800546
Labeler code 50580
Product ID 50580-546_da52fc7a-771b-ad90-e053-2a95a90a3ca3
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-07-13
Marketing end 0000-00-00
Substance PHENYLEPHRINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 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 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 Phenylephrine ACTIVE MOIETY 1WS297W6MV SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 aluminum oxide INACTIVE INGREDIENT LMI26O6933 SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 carnauba wax INACTIVE INGREDIENT R12CBM0EIZ SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 powdered cellulose INACTIVE INGREDIENT SMD1X3XO9M SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 sodium starch glycolate Type A potato INACTIVE INGREDIENT 5856J3G2A2 SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 talc INACTIVE INGREDIENT 7SEV7J4R1U SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP SUDAFED PE CONGESTION (PHENYLEPHRINE HYDROCHLORIDE) TABLET [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50580-546-50 50580054650 1 BLISTER PACK in 1 CARTON (50580-546-50) > 18 TABLET in 1 BLISTER PACK 1 blister pack 2015-07-13 0000-00-00 No No Current