Application 017941

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	SUDAFED 12 HOUR	PSEUDOEPHEDRINE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N017941-002	SUDAFED 12 HOUR	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	HyVee Inc	8c4c786c-2b0f-4a23-a87d-effbcfe0c857	2026-06-15	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
SudoGest	PSEUDOEPHEDRINE HYDROCHLORIDE	Major Pharmaceuticals	78faa497-6743-b85b-e053-2a91aa0ae822	2026-05-12	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	3bf95c58-4fd9-4caa-a54f-2e61a5eacae8	2026-05-06	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Publix Super Markets Inc	06092347-33fe-46b8-829c-70e4ca15ecf2	2026-04-01	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
leader 12 hour nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	8b8d374c-592e-44fc-a6cc-9f9e73ef914c	2026-02-25	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
sinus and nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	e39daa3c-1901-4966-b85e-ab76d7bd1216	2026-02-17	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
equate sinus 12 hour	PSEUDOEPHEDRINE HYDROCHLORIDE	Wal-Mart Stores Inc	de65b99e-85e9-46c1-88b2-727c7ed8882a	2026-02-11	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Sportpharm LLC	3b5c81b7-7464-129f-e063-6294a90a48c0	2026-02-06	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	WALGREEN CO.	1425a847-bf34-1795-e063-6294a90a85b6	2026-02-03	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	0a2672f0-4e6f-48c9-8571-2d09f06253d7	2026-01-29	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Aurohealth LLC	77e4132e-470e-4fb4-bc2f-df2e59061ba9	2026-01-06	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
SINUS AND NASAL DECONGESTANT	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d7646859-f996-46cd-a0b9-56b860f60901	2026-01-05	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Good Sense Suphedrine 12 Hour	PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	1de8a7f6-e7bb-437d-8794-c4b9f43b89c9	2025-10-30	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Sudafed Sinus Congestion 12 Hour	PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	0e4717a1-914b-466d-8bf0-d37ebc32fdb3	2025-09-15	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Meijer Distribution Inc	4d431663-4b6a-4b00-9bbd-87d2c6b8ddad	2025-05-04	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	810ce630-41be-4e15-b64a-d70f63abaf62	2025-04-24	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Zephrex D	PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	5468a7e2-361b-494f-9ca3-1b62f3819f65	2024-11-11	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Sudafed Sinus Congestion 12 Hour	PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	d600b5d5-7d95-4ad6-a95b-6d73502743d7	2024-11-08	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
SUDAFED Sinus Congestion	PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	c05d7e27-6821-468f-b27d-9c0b02a07b0f	2024-11-08	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Childrens Sudafed Nasal Decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	52e9307b-ad38-4f65-bb2f-4fa262e82010	2024-11-08	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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