Application 022129

Type: NDA
Sponsor: SHIONOGI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ULESFIA	BENZYL ALCOHOL	LOTION;TOPICAL	5%	Yes	No

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
N022129-001	ULESFIA	BENZYL ALCOHOL	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL		RLD	2009-04-09

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	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD	2009-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD	2009-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD	2009-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD	2009-04-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD	2009-04-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD	2009-04-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD	2009-04-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD	2009-04-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD	2009-04-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD	2009-04-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD	2009-04-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD, RS	2009-04-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022129-001	ULESFIA	5%	LOTION / TOPICAL	RLD, RS	2009-04-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022129-001	ULESFIA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	LOTION / TOPICAL	RLD	2009-04-09	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 2 of 2 · 53 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022129-001	7294342	2024-05-19	U-970		`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022129-001	7294342	2024-05-19	U-970		`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022129-001	7294342	2024-05-19	U-970		`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022129-001	6793931	2022-07-11	U-970	Drug product	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N022129-001	7294342	2024-05-19	U-970		`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022129-001	6793931	2022-07-11	U-970	Drug product	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022129-001	7294342	2024-05-19	U-970		`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022129-001	6793931	2022-07-11	U-970	Drug product	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N022129-001	7294342	2024-05-19	U-970		`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022129-001	6793931	2022-07-11	U-970	Drug product	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N022129-001	7294342	2024-05-19	U-970		`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022129-001	6793931	2022-07-11	U-970	Drug product	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022129-001	7294342	2024-05-19	U-970		`cb3db0bc1861…`

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
Zilactin Early Relief Cold Sore	BENZYL ALCOHOL	ASCENT CONSUMER PRODUCTS, INC	42ef8bfa-c4d9-01cf-e063-6394a90ac88a	2025-11-06	Warnings	Name fallback generic name: BENZYL ALCOHOL

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23594-780	Ulesfia	benzyl alcohol	Cerecor, Inc.	NDA	Current
23594-780	Ulesfia	benzyl alcohol	Zylera Pharmaceuticals, L	NDA	Current
69202-780	Ulesfia	benzyl alcohol	Lachlan Pharmaceuticals	NDA	Current
69202-780	Ulesfia	benzyl alcohol	Lachlan Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
62692	SUPPL	2020-04-27
62683	SUPPL	2020-04-27
38293	SUPPL	2012-07-30
29303	SUPPL	2012-07-17
17000	SUPPL	2010-06-24
6947	SUPPL	2010-06-24
24248	ORIG	2009-06-01
21944	ORIG	2009-06-01
38292	ORIG	2009-04-16
29302	ORIG	2009-04-16
53189	ORIG	1900-01-01
53188	ORIG	1900-01-01
53187	ORIG	1900-01-01