Acanya

Product NDC: 13548-132
Requested package NDC: 13548-132-50
11-digit product format: 135480132
Labeler code: 13548
Product ID: 13548-132_110dde63-b7d7-49af-aa96-9daefccb84ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin Phosphate and Benzoyl Peroxide
Dosage form: GEL
Route: TOPICAL
Labeler: Bausch Health US, LLC
Application: NDA050819
Marketing category: NDA
Marketing start: 2010-07-26
Substance: CLINDAMYCIN PHOSPHATE; BENZOYL PEROXIDE
Active strength: 10; 25 mg/g; mg/g
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050819-001	ACANYA	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23
N050819-002	ONEXTON	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N050819-001	AB
N050819-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 19 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N050819-001	10220049	2029-06-03	U-916	Drug product	2019-03-08
N050819-001	10624918	2029-06-03	U-916		2020-05-11
N050819-001	8663699	2029-06-03	U-124		2014-03-06
N050819-001	8895070	2029-06-03	U-124		2015-05-19
N050819-001	9078870	2029-06-03		Drug product	2015-10-13
N050819-001	8288434	2029-08-05	U-124	Drug product	2012-10-19
N050819-002	10137142	2029-06-03	U-916	Drug product	2018-11-28
N050819-002	10220049	2029-06-03	U-916	Drug product	2019-03-08
N050819-002	9504704	2029-06-03	U-124	Drug product	2016-12-01
N050819-002	9504704	2029-06-03	U-134	Drug product	2016-12-01
N050819-002	9504704	2029-06-03	U-818	Drug product	2016-12-01
N050819-002	9504704	2029-06-03	U-916	Drug product	2016-12-01
N050819-002	9561208	2029-06-03	U-916	Drug product	2017-02-08
N050819-002	8288434	2029-08-05	U-1033	Drug product	2014-12-03
N050819-002	8288434	2029-08-05	U-124	Drug product	2014-12-03
N050819-002	8288434	2029-08-05	U-134	Drug product	2014-12-03
N050819-002	8288434	2029-08-05	U-818	Drug product	2014-12-03
N050819-002	8288434	2029-08-05	U-916	Drug product	2014-12-03
N050819-002	8288434	2029-08-05	U-921	Drug product	2014-12-03

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2014-11-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL		RLD, RS	2014-11-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL		RLD, RS	2014-11-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL		RLD, RS	2014-11-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050819-001	ACANYA	2.5%;EQ 1.2% BASE	GEL / TOPICAL	AB	RLD, RS	2008-10-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050819-002	ONEXTON	3.75%;EQ 1.2% BASE	GEL / TOPICAL		RLD, RS	2014-11-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 65 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N050819-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050819-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050819-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050819-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050819-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050819-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050819-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050819-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050819-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050819-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050819-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050819-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050819-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050819-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050819-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050819-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050819-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050819-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050819-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050819-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050819-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050819-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050819-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050819-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050819-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050819-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050819-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050819-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050819-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050819-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050819-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050819-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050819-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050819-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050819-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050819-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050819-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050819-001	AB	1	`5aa47cf7b7d7…`

Observed Orange Book patent history#

Patent history page 1 of 21 · 813 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N050819-001	10220049	2029-06-03	U-916	Drug product	2019-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-001	10624918	2029-06-03	U-916		2020-05-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-001	8663699	2029-06-03	U-124		2014-03-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-001	8895070	2029-06-03	U-124		2015-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-001	9078870	2029-06-03		Drug product	2015-10-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-001	8288434	2029-08-05	U-124	Drug product	2012-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	10137142	2029-06-03	U-916	Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	10220049	2029-06-03	U-916	Drug product	2019-03-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	9504704	2029-06-03	U-134	Drug product	2016-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	9504704	2029-06-03	U-818	Drug product	2016-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	9504704	2029-06-03	U-916	Drug product	2016-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	9504704	2029-06-03	U-124	Drug product	2016-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	9561208	2029-06-03	U-916	Drug product	2017-02-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	8288434	2029-08-05	U-818	Drug product	2014-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	8288434	2029-08-05	U-124	Drug product	2014-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	8288434	2029-08-05	U-134	Drug product	2014-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	8288434	2029-08-05	U-1033	Drug product	2014-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	8288434	2029-08-05	U-921	Drug product	2014-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050819-002	8288434	2029-08-05	U-916	Drug product	2014-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050819-001	10220049	2029-06-03	U-916	Drug product	2019-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-001	10624918	2029-06-03	U-916		2020-05-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-001	8663699	2029-06-03	U-124		2014-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-001	8895070	2029-06-03	U-124		2015-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-001	9078870	2029-06-03		Drug product	2015-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-001	8288434	2029-08-05	U-124	Drug product	2012-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	10137142	2029-06-03	U-916	Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	10220049	2029-06-03	U-916	Drug product	2019-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	9504704	2029-06-03	U-134	Drug product	2016-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	9504704	2029-06-03	U-818	Drug product	2016-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	9504704	2029-06-03	U-916	Drug product	2016-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	9504704	2029-06-03	U-124	Drug product	2016-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	9561208	2029-06-03	U-916	Drug product	2017-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	8288434	2029-08-05	U-818	Drug product	2014-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	8288434	2029-08-05	U-124	Drug product	2014-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	8288434	2029-08-05	U-134	Drug product	2014-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	8288434	2029-08-05	U-1033	Drug product	2014-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	8288434	2029-08-05	U-921	Drug product	2014-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050819-002	8288434	2029-08-05	U-916	Drug product	2014-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050819-001	10220049	2029-06-03	U-916	Drug product	2019-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050819-001	10624918	2029-06-03	U-916		2020-05-11	`011fe1cb6892…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLINDAMYCIN PHOSPHATE	10 mg/g
BENZOYL PEROXIDE	25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EH6D7113I8	Internal UNII lookup
W9WZN9A0GM	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3dcd2c96-72b1-4a9f-b65c-08198d63b7df	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d8f81258-db12-0761-46cc-8ff6e62e9302	Product name	4	20240422
b7b2fa42-1c77-d724-81f0-87da60a77e79	Product name	3	20240320
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0	Product name	3	20230425
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
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3	Product name	9	20220928
b72227d6-0388-43bd-995b-b762d2754cd5	Product name	1	20220706
a92d22e0-3af4-f301-bc88-27ff030b0070	Product name	2	20220316
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
5ce6ce33-4f2b-3ce0-757d-e520013280cf	Product name	5	20180719
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810
b92a26f1-6926-4817-be73-e26ab4c2146f	Product name	1	20170602
028d6c95-5012-6976-2075-dee0ae6fefe2	Product name	1	20140508
468b2c08-8adb-8d0f-8257-c6515a061424	Product name	1	20140508
8959fb29-d86f-c521-666a-b4cb22233594	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13548-132-50	Acanya	1 in 1 CARTON	GEL	1		16
13548-132-50	Acanya	50 g in 1 BOTTLE, PUMP	GEL	50		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13548-132-50	GM - Gram	13548-132	9ca01665-fb37-47f6-b4ff-cf1a7557bd73	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzoyl Peroxide	ACTIVE INGREDIENT	W9WZN9A0GM	ACANYA (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [CORIA LABORATORIES]	8
Clindamycin Phosphate	ACTIVE INGREDIENT	EH6D7113I8	ACANYA (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [CORIA LABORATORIES]	8
Benzoyl Peroxide	ACTIVE MOIETY	W9WZN9A0GM	ACANYA (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [CORIA LABORATORIES]	8
Clindamycin	ACTIVE MOIETY	3U02EL437C	ACANYA (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [CORIA LABORATORIES]	8
Carbomer Homopolymer Type C	INACTIVE INGREDIENT	4Q93RCW27E	ACANYA (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [CORIA LABORATORIES]	8
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	ACANYA (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [CORIA LABORATORIES]	8
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	ACANYA (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [CORIA LABORATORIES]	8
Water	INACTIVE INGREDIENT	059QF0KO0R	ACANYA (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [CORIA LABORATORIES]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13548-132	ACANYA (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [BAUSCH HEALTH US, LLC]	16	Current NDC, Legacy NDC, 2 package rows	20201210_3dcd2c96-72b1-4a9f-b65c-08198d63b7df.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Oceanside Pharmaceuticals	1d53ec2b-d33d-4245-99f1-e41b30303660	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050819 application number: NDA050819
ONEXTON	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Bausch Health US, LLC	697e760a-c206-4565-8f4e-a8085e215827	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050819 application number: NDA050819
Acanya	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Bausch Health US, LLC	3dcd2c96-72b1-4a9f-b65c-08198d63b7df	2020-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050819 application number: NDA050819 ndc (package): 13548-132-50 ndc (product): 13548-132 ndc11 (package): 13548013250
Clindamycin Phosphate and Benzoyl Peroxide	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	Oceanside Pharmaceuticals	edae294f-cc8b-4f94-8d90-4c764fda307b	2020-09-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050819 application number: NDA050819

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EH6D7113I8	CLINDAMYCIN PHOSPHATE	24729-96-2	CLINDAMYCIN PHOSPHATE
W9WZN9A0GM	BENZOYL PEROXIDE	94-36-0	BENZOYL PEROXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13548-132-50	13548013250	1 BOTTLE, PUMP in 1 CARTON (13548-132-50) / 50 g in 1 BOTTLE, PUMP	2010-07-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acanya	Bausch Health US, LLC \| Contract Pharmaceuticals Limited Canada \| Bausch Health Companies, Inc.	2020-09-30	HUMAN PRESCRIPTION DRUG LABEL	16