TWYNEO

Product NDC: 79167-301
Requested package NDC: 79167-301-30
11-digit product format: 791670301
Labeler code: 79167
Product ID: 79167-301_acb7b3f4-5c79-4dbf-8c91-9a11773dd6ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tretinoin and benzoyl peroxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Sol-Gel Technologies, Inc.
Application: NDA214902
Marketing category: NDA
Marketing start: 2022-03-01
Marketing end: 0000-00-00
Substance: BENZOYL PEROXIDE; TRETINOIN
Active strength: 30 mg/g; mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	79167-301	79167-301-30	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N214902-001	TWYNEO	BENZOYL PEROXIDE; TRETINOIN	3%;0.1%	CREAM / TOPICAL		RLD, RS	2021-07-26

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214902-001	12156946	2028-02-03		Drug product	2024-12-18
N214902-001	8617580	2028-02-03		Drug product	2021-11-24
N214902-001	9868103	2028-08-08	U-3194	Drug product	2021-08-23
N214902-001	10653899	2030-12-30	U-3194	Drug product	2021-11-24
N214902-001	11071878	2030-12-30		Drug product	2021-08-23
N214902-001	12070629	2030-12-30	U-3987	Drug product	2024-09-18
N214902-001	12053546	2032-06-29		Drug product	2024-08-26
N214902-001	10420743	2038-07-12	U-3194		2021-11-24
N214902-001	12357602	2038-07-12	U-3987	Drug product	2025-07-17
N214902-001	12295935	2040-12-27	U-3987		2025-05-23
N214902-001	12133919	2041-05-23	U-3987	Drug product	2024-12-03
N214902-001	12257348	2041-05-23	U-3987	Drug product	2025-04-10
N214902-001	12491163	2041-05-23	U-3987	Drug product	2025-12-16

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD	2021-07-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD	2021-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214902-001	12156946	2028-02-03		Drug product	2024-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	8617580	2028-02-03		Drug product	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	9868103	2028-08-08	U-3194	Drug product	2021-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	10653899	2030-12-30	U-3194	Drug product	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	11071878	2030-12-30		Drug product	2021-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12070629	2030-12-30	U-3987	Drug product	2024-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12053546	2032-06-29		Drug product	2024-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	10420743	2038-07-12	U-3194		2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12357602	2038-07-12	U-3987	Drug product	2025-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12295935	2040-12-27	U-3987		2025-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12133919	2041-05-23	U-3987	Drug product	2024-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12257348	2041-05-23	U-3987	Drug product	2025-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12491163	2041-05-23	U-3987	Drug product	2025-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12156946	2028-02-03		Drug product	2024-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	8617580	2028-02-03		Drug product	2021-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	9868103	2028-08-08	U-3194	Drug product	2021-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	10653899	2030-12-30	U-3194	Drug product	2021-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	11071878	2030-12-30		Drug product	2021-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12070629	2030-12-30	U-3987	Drug product	2024-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12053546	2032-06-29		Drug product	2024-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	10420743	2038-07-12	U-3194		2021-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12357602	2038-07-12	U-3987	Drug product	2025-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12295935	2040-12-27	U-3987		2025-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12133919	2041-05-23	U-3987	Drug product	2024-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12257348	2041-05-23	U-3987	Drug product	2025-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12156946	2028-02-03		Drug product	2024-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	8617580	2028-02-03		Drug product	2021-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	9868103	2028-08-08	U-3194	Drug product	2021-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	10653899	2030-12-30	U-3194	Drug product	2021-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	11071878	2030-12-30		Drug product	2021-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12070629	2030-12-30	U-3987	Drug product	2024-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12053546	2032-06-29		Drug product	2024-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	10420743	2038-07-12	U-3194		2021-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12357602	2038-07-12	U-3987	Drug product	2025-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12295935	2040-12-27	U-3987		2025-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12133919	2041-05-23	U-3987	Drug product	2024-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12257348	2041-05-23	U-3987	Drug product	2025-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214902-001	12156946	2028-02-03		Drug product	2024-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214902-001	8617580	2028-02-03		Drug product	2021-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214902-001	9868103	2028-08-08	U-3194	Drug product	2021-08-23	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214902-001	NC	2024-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214902-001	NC	2024-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214902-001	NC	2024-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214902-001	NC	2024-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214902-001	NC	2024-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214902-001	NC	2024-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214902-001	NC	2024-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214902-001	NC	2024-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214902-001	NC	2024-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214902-001	NC	2024-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214902-001	NC	2024-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214902-001	NC	2024-07-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214902-001	NC	2024-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214902-001	NC	2024-07-26	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214902-001	NC	2024-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214902-001	NC	2024-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214902-001	NC	2024-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214902-001	NC	2024-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214902-001	NC	2024-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214902-001	NC	2024-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214902-001	NC	2024-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214902-001	NC	2024-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214902-001	NC	2024-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214902-001	NC	2024-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214902-001	NC	2024-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214902-001	NC	2024-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214902-001	NC	2024-07-26	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Twyneo	BENZOYL PEROXIDE AND TRETINOIN	Mayne Pharma Commercial LLC	654ae869-5bc0-40b3-a423-dcc3270c05d8	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214902 application number: NDA214902
TWYNEO	TRETINOIN AND BENZOYL PEROXIDE	Galderma Laboratories, L.P.	27208dff-e376-4c18-b56e-0a260f685a39	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214902 application number: NDA214902

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W9WZN9A0GM	BENZOYL PEROXIDE	94-36-0	BENZOYL PEROXIDE
5688UTC01R	TRETINOIN	302-79-4	TRETINOIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
79167-301-30	79167030130	1 BOTTLE, PUMP in 1 CARTON (79167-301-30) > 30 g in 1 BOTTLE, PUMP	2022-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TWYNEO	Sol-Gel Technologies, Inc. \| Sol-Gel Technologies Ltd. \| Nouryon Chemicals, S.A. de C.V. \| Siegfried PharmaChemikalien Minden GmbH \| Douglas Manufacturing Limited	2021-12-13	HUMAN PRESCRIPTION DRUG LABEL	3