Benzaclin

Product NDC: 0187-5190
11-digit product format: 001875190
Labeler code: 0187
Product ID: 0187-5190_4d429947-c5e7-4bb1-8881-6fd591b637b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin phosphate and benzoyl peroxide
Dosage form: GEL
Route: TOPICAL
Labeler: Bausch Health US LLC
Application: NDA050756
Marketing category: NDA
Marketing start: 2000-12-21
Marketing end: 0000-00-00
Substance: BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Active strength: 50 mg/g; mg/g
Pharmacologic classes: Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0187-5190		D	Discontinued by firm	2026-10-05
excluded package	package	0187-5190	0187-5190-25	D	Discontinued by firm	2026-10-05
excluded package	package	0187-5190	0187-5190-35	D	Discontinued by firm	2026-10-05
excluded package	package	0187-5190	0187-5190-50	D	Discontinued by firm	2026-10-05

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 · 37 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-5190-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-5190-35	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-5190-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-5190-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-5190-35	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-5190-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0187-5190-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0187-5190-35	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0187-5190-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0187-5190-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0187-5190-35	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0187-5190-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0187-5190-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0187-5190-35	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0187-5190-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0187-5190-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0187-5190-35	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0187-5190-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0187-5190-25	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0187-5190-35	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0187-5190-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0187-5190-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0187-5190-35	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0187-5190-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0187-5190-25	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0187-5190-35	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0187-5190-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0187-5190-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0187-5190-35	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0187-5190-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0187-5190-25	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0187-5190-35	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0187-5190-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0187-5190-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0187-5190-35	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0187-5190-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N050756-001	BENZACLIN	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21
N050756-002	BENZACLIN	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20

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	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL		RLD	2000-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL	AB	RLD, RS	2000-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL	AB	RLD, RS	2000-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL	AB	RLD, RS	2000-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050756-001	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL	AB	RLD, RS	2000-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050756-002	BENZACLIN	5%;EQ 1% BASE	GEL / TOPICAL			2007-04-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050756-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050756-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050756-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050756-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050756-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050756-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050756-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050756-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050756-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050756-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050756-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050756-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050756-001	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N050756-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050756-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050756-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050756-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050756-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-5190-25	GM - Gram	0187-5190	52bbb906-f8a4-46aa-a09f-27db2945726e	1	2013-07-02
0187-5190-35	GM - Gram	0187-5190	c1af9007-bd34-47db-b427-b2e389488a4e	1	2013-07-02
0187-5190-50	GM - Gram	0187-5190	f0792373-610c-498e-8fe6-cc0d695c4479	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOYL PEROXIDE	ACTIVE INGREDIENT	W9WZN9A0GM	BENZACLIN (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
CLINDAMYCIN PHOSPHATE	ACTIVE INGREDIENT	EH6D7113I8	BENZACLIN (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
BENZOYL PEROXIDE	ACTIVE MOIETY	W9WZN9A0GM	BENZACLIN (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3
CLINDAMYCIN	ACTIVE MOIETY	3U02EL437C	BENZACLIN (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-5190	BENZACLIN (CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE) GEL [BAUSCH HEALTH US LLC]	15	Legacy NDC	20230204_4c6b2aca-d940-42af-a068-418f015d277a.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-5190-25	00187519025	1 JAR in 1 CARTON (0187-5190-25) > 25 g in 1 JAR	1 jar	2000-12-21	0000-00-00	No	No	Current
0187-5190-35	00187519035	1 BOTTLE, PUMP in 1 CARTON (0187-5190-35) > 35 g in 1 BOTTLE, PUMP		2000-12-21	0000-00-00	No	No	Current
0187-5190-50	00187519050	1 BOTTLE, PUMP in 1 CARTON (0187-5190-50) > 50 g in 1 BOTTLE, PUMP		2000-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BenzaClin ® Topical Gel (clindamycin - benzoyl peroxide gel)	Bausch Health US LLC \| Bausch Health Companies Inc.	2017-02-16	HUMAN PRESCRIPTION DRUG LABEL	15