Congestion Relief

Product NDC: 41250-158
11-digit product format: 412500158
Labeler code: 41250
Product ID: 41250-158_d7794f31-7ab8-4ca1-b01b-87b955d012e2
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen, phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Meijer Distribution Inc
Application: ANDA203200
Marketing category: ANDA
Marketing start: 2014-09-17
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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A203200-001	IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	200MG;10MG	TABLET / ORAL	2014-07-03	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Congestion Relief
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
84f932b6-0aee-4cf9-b4b9-213560c42c1d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41250-158-60	Congestion Relief	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		3
41250-158-60	Congestion Relief	20 in 1 CARTON	TABLET, FILM COATED	20		3

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-158	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	3	Current NDC, Legacy NDC, 2 package rows	20191207_84f932b6-0aee-4cf9-b4b9-213560c42c1d.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.

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 ndc (product): 41250-158

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1369775	ibuprofen 200 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	84f932b6-0aee-4cf9-b4b9-213560c42c1d	3
1369775	ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	84f932b6-0aee-4cf9-b4b9-213560c42c1d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-158-60	41250015860	20 BLISTER PACK in 1 CARTON (41250-158-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK	20 blister pack	2014-09-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. Congestion Relief Drug Facts	Meijer Distribution Inc	2019-12-05	HUMAN OTC DRUG LABEL	3