Home NDC 50580-436 Sudafed PE Head Congestion Plus Pain
Product NDC 50580-436
11-digit product format 505800436
Labeler code 50580
Product ID 50580-436_2ffbcc44-0ef3-b149-e063-6394a90ae7f5
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen and Phenylephrine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kenvue Brands LLC
Application ANDA203200
Marketing category ANDA
Marketing start 2019-06-17
Substance IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 200; 10 mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203200-001 IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE 200MG;10MG TABLET / ORAL 2014-07-03 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Sudafed PE Head Congestion Plus Pain
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1369775 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-436-01 Sudafed PE Head Congestion Plus Pain 10 in 1 BLISTER PACK TABLET, FILM COATED 10 5 50580-436-01 Sudafed PE Head Congestion Plus Pain 2 in 1 CARTON TABLET, FILM COATED 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-436 SUDAFED PE HEAD CONGESTION PLUS PAIN (IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] 5 Current NDC, Legacy NDC, 2 package rows 20250313_76513fb2-7323-4f1f-8a10-92f8f603cf97.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50580-436-01 50580043601 2 BLISTER PACK in 1 CARTON (50580-436-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2019-06-17 0000-00-00 No No Current