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HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	120MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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SUDAFED 12 HOUR	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD, Approved before 1982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N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`84e616aacf4f…`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N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`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UTC	2026-02	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`011fe1cb6892…`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this ZIP	2025-12	N017941-002	SUDAFED 12 HOUR	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL	RLD, Approved before 1982	`31067a03dcf5…`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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
sinus	PSEUDOEPHEDRINE HYDROCHLORIDE	Kroger Company	18812f2a-9b66-45a7-9631-123da6fd1c1f	2024-09-20	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
good neighbor pharmacy nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Amerisource Bergen	d84a0c76-ad50-4616-9252-84ca25a19ca0	2024-05-30	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
12 Hour Nasal Decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	CARDINAL HEALTH	0ec510e8-a8cf-474b-9da4-2ac5122d6b49	2024-05-20	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Ohm Laboratories Inc.	4e98dd9f-4ab9-4d95-95b0-799ce217da70	2024-01-18	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Equaline 12 Hour Decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	bd5c2093-f812-4dfe-80ea-68cb4e65a09c	2023-08-03	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Nasal Decongestant D	PSEUDOEPHEDRINE HYDROCHLORIDE	Walgreen Company	9572b6c9-172b-459e-82d1-7f92f0eaec8e	2022-10-20	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
topcare 12 hour decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Topco Associates LLC	4841c79a-fb92-4209-929a-e4ea0c4015dd	2022-10-05	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Walgreen Company	e33d6ca8-7b3c-42ad-85d3-3302a949501e	2022-05-18	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC DBA LEADER	a2189d7d-9335-4e96-8f6d-95c583739ac0	2022-05-12	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	918b2a90-532b-4358-bdff-9ad48c167a7e	2020-08-11	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Strategic Sourcing Services	53acd8d9-b9d8-4a38-8597-32043548d832	2020-07-01	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	HEB	d9b46ff2-8bde-47c0-bc63-b19dbe7e197b	2019-05-29	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
12 Hour Nasal Decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	85955336-3f79-457d-822c-f8be019729d1	2019-05-23	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Ohm Laboratories Inc.	f398ceab-e3d2-421d-813e-b66369f65472	2019-05-01	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	3a3d11e5-ebbf-4356-8ae6-4e5656b5644c	2019-04-10	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Chain Drug Consortium, LLC	aec6412a-b62c-44c8-84f5-77f5fa441028	2019-04-10	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	SAM'S WEST INC	5a885a10-7751-44f1-b2d9-a918f27604df	2019-03-29	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	DISCOUNT DRUG MART	7668ad20-1ca7-4d93-b3a3-03cfde141f86	2019-03-19	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Safeway Inc.	01a5d9dd-f123-443b-b968-412c0aadaaa2	2019-03-14	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Chain Drug Marketing Association Inc.	880d368f-0ce3-4993-b5b1-13bf01310516	2019-03-14	Warnings	Name fallback generic name: PSEUDOEPHEDRINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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