Application 203200

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	TABLET;ORAL	200MG;10MG	No	No

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	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…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sudafed PE Head Congestion Plus Pain	IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	76513fb2-7323-4f1f-8a10-92f8f603cf97	2025-03-10	Warnings	Exact identifier application applno (ANDA): 203200 application number: ANDA203200 ndc (product): 50580-436
Equaline congestion relief	IBUPROFEN, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	06dcece5-0fdc-4ff1-a8b1-fadb503a9f50	2023-08-08	Warnings	Exact identifier application applno (ANDA): 203200 application number: ANDA203200 ndc (product): 41163-158
Congestion Relief	IBUPROFEN, PHENYLEPHRINE HCL	Meijer Distribution Inc	84f932b6-0aee-4cf9-b4b9-213560c42c1d	2019-12-05	Warnings	Exact identifier application applno (ANDA): 203200 application number: ANDA203200 ndc (product): 41250-158

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-0158	walprofen congestion relief and pain	Ibuprofen, phenylephrine HCl	Walgreen Company	ANDA	Current
0363-0158	walprofen congestion relief and pain	Ibuprofen, phenylephrine HCl	Walgreen Company	ANDA	Current
37808-158	Congestion Relief	Ibuprofen, phenylephrine HCl	H E B	ANDA	Current
37808-158	Congestion Relief	Ibuprofen, phenylephrine HCl	H E B	ANDA	Current
41163-158	Equaline congestion relief	Ibuprofen, phenylephrine HCl	Supervalu Inc	ANDA	Current
41163-158	Equaline congestion relief	Ibuprofen, phenylephrine HCl	Supervalu Inc	ANDA	Current
41163-158	Equaline congestion relief	Ibuprofen, phenylephrine HCl	Supervalu Inc	ANDA	Current
41250-158	Congestion Relief	Ibuprofen, phenylephrine HCl	Meijer Distribution Inc	ANDA	Current
41250-158	Congestion Relief	Ibuprofen, phenylephrine HCl	Meijer Distribution Inc	ANDA	Current
46122-196	good neighbor pharmacy congestion relief	Ibuprofen, phenylephrine HCl	Amerisource Bergen	ANDA	Current
46122-196	good neighbor pharmacy congestion relief	Ibuprofen, phenylephrine HCl	Amerisource Bergen	ANDA	Current
49781-071	Leader Congestion Relief	Ibuprofen, phenylephrine HCl	Cardinal Health	ANDA	Current
50580-436	Sudafed PE Head Congestion Plus Pain	Ibuprofen and Phenylephrine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	ANDA	Current
50580-436	Sudafed PE Head Congestion Plus Pain	Ibuprofen and Phenylephrine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	ANDA	Current
59779-828	congestion relief	Ibuprofen, phenylephrine HCl	CVS Pharmacy	ANDA	Current