Twyneo

Product NDC: 51862-771
11-digit product format: 518620771
Labeler code: 51862
Product ID: 51862-771_8557c350-45c9-48f8-8e1c-cc7569b3e7b6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzoyl Peroxide and Tretinoin
Dosage form: CREAM
Route: TOPICAL
Labeler: Mayne Pharma Commercial LLC
Application: NDA214902
Marketing category: NDA
Marketing start: 2025-08-01
Substance: BENZOYL PEROXIDE; TRETINOIN
Active strength: 30; 1 mg/g; mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Twyneo
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOYL PEROXIDE	30 mg/g
TRETINOIN	1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W9WZN9A0GM	Internal UNII lookup
5688UTC01R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2565807	Internal RxNorm lookup
2565812	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
654ae869-5bc0-40b3-a423-dcc3270c05d8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60	Product name	6	20251124
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ec	Product name	2	20250521
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d9d61457-6a5a-41fc-b418-e5479a2904b7	Product name	2	20230303
32012d5c-25ac-49c7-9d4c-1313177fff7c	Product name	1	20230112
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
3f45980c-c196-47e5-0e5e-48b7c57327c5	Product name	5	20200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
503b047e-e62d-4745-9011-522b13bc701b	Product name	1	20181206
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810
7d41caa2-0b5d-9b03-ab8d-84271de26ef4	Product name	2	20170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572	Product name	2	20150818
0a8118e4-08c6-b395-9ddc-d3e425e0493a	Product name	1	20140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579	Product name	1	20140508
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51862-771-30	Twyneo	1 in 1 CARTON	CREAM	1		1
51862-771-30	Twyneo	30 g in 1 BOTTLE, PUMP	CREAM	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-771-30	GM - Gram	51862-771	f9154d12-38bd-41af-8a7e-c042cc59c269	1	2025-09-12

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 ndc (product): 51862-771
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2565807	benzoyl peroxide 3 % / tretinoin 0.1 % Topical Cream	PSN	654ae869-5bc0-40b3-a423-dcc3270c05d8	1
2565812	Twyneo 3 % / 0.1 % Topical Cream	PSN	654ae869-5bc0-40b3-a423-dcc3270c05d8	1
2565812	benzoyl peroxide 30 MG/ML / tretinoin 1 MG/ML Topical Cream [Twyneo]	SBD	654ae869-5bc0-40b3-a423-dcc3270c05d8	1
2565807	benzoyl peroxide 30 MG/ML / tretinoin 1 MG/ML Topical Cream	SCD	654ae869-5bc0-40b3-a423-dcc3270c05d8	1
2565807	benzoyl peroxide 3 % / tretinoin 0.1 % Topical Cream	SY	654ae869-5bc0-40b3-a423-dcc3270c05d8	1
2565812	Twyneo (benzoyl peroxide 3 % / tretinoin 0.1 % ) Topical Cream	SY	654ae869-5bc0-40b3-a423-dcc3270c05d8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51862-771-30	51862077130	1 BOTTLE, PUMP in 1 CARTON (51862-771-30) / 30 g in 1 BOTTLE, PUMP	2025-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Twyneo	Mayne Pharma Commercial LLC \| Douglas Manufacturing Limited	2025-08-11	HUMAN PRESCRIPTION DRUG LABEL	1