Application 020021

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	SUDAFED 24 HOUR	PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	240MG	Yes	Yes

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
N020021-002	SUDAFED 24 HOUR	PSEUDOEPHEDRINE HYDROCHLORIDE	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1992-12-15

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020021-002	SUDAFED 24 HOUR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020021-002	SUDAFED 24 HOUR	240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020021-002	SUDAFED 24 HOUR	240MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	1992-12-15	`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 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Publix Super Markets Inc	9a6ece8b-7036-4cad-aeb3-993ef4bf614f	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50580-240	Sudafed Sinus Congestion 24 Hour	Pseudoephedrine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-240	Sudafed Sinus Congestion 24 Hour	Pseudoephedrine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-240	Sudafed Sinus Congestion 24 Hour	Pseudoephedrine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-669	Sudafed	Pseudoephedrine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-669	Sudafed	Pseudoephedrine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
50580-669	Sudafed	Pseudoephedrine Hydrochloride	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56680	SUPPL	2018-12-07
56482	SUPPL	2018-11-23
41121	SUPPL	2007-07-06
20451	SUPPL	2007-07-06
20450	SUPPL	2007-07-06
41120	SUPPL	2007-05-09
20449	SUPPL	2007-05-09
20448	SUPPL	2007-05-09