congestion relief

Product NDC: 59779-828
11-digit product format: 597790828
Labeler code: 59779
Product ID: 59779-828_b15a4a04-6588-41dc-8c76-986d6198f929
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen, phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CVS Pharmacy
Application: ANDA203200
Marketing category: ANDA
Marketing start: 2014-09-19
Marketing end: 0000-00-00
Substance: IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 200 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59779-828		D	Discontinued by firm	2026-08-10
excluded package	package	59779-828	59779-828-46	D	Discontinued by firm	2026-08-10
excluded package	package	59779-828	59779-828-60	D	Discontinued by firm	2026-08-10

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 · 36 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	59779-828-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59779-828-46	`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	59779-828-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59779-828-46	`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	59779-828-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59779-828-46	`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	59779-828-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59779-828-46	`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	59779-828-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59779-828-46	`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	59779-828-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59779-828-46	`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	59779-828-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59779-828-46	`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	59779-828-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59779-828-46	`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	59779-828-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59779-828-46	`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	59779-828-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59779-828-46	`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	59779-828-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59779-828-46	`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	59779-828-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59779-828-46	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-828-46	EA - Each	59779-828	60ad70f1-54cd-48b7-8c62-e745425aaf60	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	3

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
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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WK2XYI10QM	IBUPROFEN	15687-27-1	IBUPROFEN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE