Congestion Relief

Product NDC: 37808-158
Requested package NDC: 37808-158-60
11-digit product format: 378080158
Labeler code: 37808
Product ID: 37808-158_7d88c73b-b8ae-44e3-b1dd-a6e5cd4b4009
Type: HUMAN OTC DRUG
Nonproprietary name: Ibuprofen, phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H E B
Application: ANDA203200
Marketing category: ANDA
Marketing start: 2016-04-18
Marketing end: 0000-00-00
Substance: IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 200 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	37808-158	37808-158-60	D	Discontinued by firm		2026-11-12

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A203200-001	IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	200MG;10MG	TABLET / ORAL	2014-07-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203200-001	IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE	200MG;10MG	TABLET / ORAL	2014-07-03	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
37808-158-60	Congestion Relief	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		3
37808-158-60	Congestion Relief	20 in 1 CARTON	TABLET, FILM COATED	20		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-158	CONGESTION RELIEF (IBUPROFEN, PHENYLEPHRINE HCL) TABLET, FILM COATED [H E B]	3	Legacy NDC, 2 package rows	20191206_8e46fe47-e429-4b0c-ae4a-9b8e5e6a5036.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 · 1 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

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	8e46fe47-e429-4b0c-ae4a-9b8e5e6a5036	3
1369775	ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	8e46fe47-e429-4b0c-ae4a-9b8e5e6a5036	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-158-60	37808015860	20 BLISTER PACK in 1 CARTON (37808-158-60) > 1 TABLET, FILM COATED in 1 BLISTER PACK	20 blister pack	2016-04-18	0000-00-00	No	No	Current