Clindamycin and Benzoyl Peroxide

Product NDC: 21922-068
Requested package NDC: 21922-068-46
11-digit product format: 219220068
Labeler code: 21922
Product ID: 21922-068_b0f57ad3-75d5-41fc-80f0-249f973d5d93
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin and Benzoyl Peroxide
Dosage form: KIT
Labeler: Encube Ethicals, Inc.
Application: ANDA204087
Marketing category: ANDA
Marketing start: 2025-10-07
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE	5%;EQ 1% BASE	GEL / TOPICAL	AB		2017-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204087-001	AB

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2017-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2017-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2017-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2017-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2017-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2017-06-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2017-06-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2017-06-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2017-06-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2017-06-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2017-06-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL	AB	2017-06-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204087-001	CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE	5%;EQ 1% BASE	GEL / TOPICAL		2017-06-27	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204087-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204087-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204087-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204087-001	AB	1	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	A204087-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204087-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204087-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204087-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204087-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204087-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204087-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204087-001	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204087-001	AB	1	`a50c72e98297…`

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: Clindamycin and Benzoyl Peroxide
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308694	Internal RxNorm lookup
358917	Internal RxNorm lookup
2676585	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
b7ba182e-4e36-4ea5-b9bb-5efa7e3f67d0	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
21922-067-39	Clindamycin and Benzoyl Peroxide	28 g in 1 BOTTLE, PUMP	GEL	28 g	50 mg in 1g	1
21922-067-41	Clindamycin and Benzoyl Peroxide	40 g in 1 JAR	GEL	40 g	50 mg in 1g	1
21922-067-42	Clindamycin and Benzoyl Peroxide	40 g in 1 BOTTLE, PUMP	GEL	40 g	50 mg in 1g	1
21922-067-62	Clindamycin and Benzoyl Peroxide	20 g in 1 JAR	GEL	20 g	50 mg in 1g	1
21922-068-43	Clindamycin and Benzoyl Peroxide	1 in 1 CARTON	KIT	1		1
21922-068-44	Clindamycin and Benzoyl Peroxide	1 in 1 CARTON	KIT	1		1
21922-068-45	Clindamycin and Benzoyl Peroxide	1 in 1 CARTON	KIT	1		1
21922-068-46	Clindamycin and Benzoyl Peroxide	1 in 1 CARTON	KIT	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21922-068-43	GM - Gram	21922-068	83c62963-c906-4e99-9d27-651d47b92090	1	2025-11-13
21922-068-45	GM - Gram	21922-068	9b31619b-65f4-47b7-ba18-2d1aaa5ba4f7	1	2025-11-13

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
Clindamycin and Benzoyl Peroxide	CLINDAMYCIN AND BENZOYL PEROXIDE	Encube Ethicals, Inc.	b7ba182e-4e36-4ea5-b9bb-5efa7e3f67d0	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204087 application number: ANDA204087 ndc (package): 21922-068-46 ndc (product): 21922-068 ndc11 (package): 21922006846

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308694	benzoyl peroxide 5 % Topical Gel	PSN	b7ba182e-4e36-4ea5-b9bb-5efa7e3f67d0	1
358917	clindamycin phosphate 1 % / benzoyl peroxide 5 % Topical Gel	PSN	b7ba182e-4e36-4ea5-b9bb-5efa7e3f67d0	1
2676585	clindamycin phosphate 1 % Twice-Daily Topical Gel	PSN	b7ba182e-4e36-4ea5-b9bb-5efa7e3f67d0	1
358917	benzoyl peroxide 0.05 MG/MG / clindamycin 0.01 MG/MG Topical Gel	SCD	b7ba182e-4e36-4ea5-b9bb-5efa7e3f67d0	1
308694	benzoyl peroxide 0.05 MG/MG Topical Gel	SCD	b7ba182e-4e36-4ea5-b9bb-5efa7e3f67d0	1
2676585	Twice-Daily clindamycin 0.01 MG/MG Topical Gel	SCD	b7ba182e-4e36-4ea5-b9bb-5efa7e3f67d0	1
358917	benzoyl peroxide 5 % / clindamycin 1 % (as clindamycin phosphate 1.2 % ) Topical Gel	SY	b7ba182e-4e36-4ea5-b9bb-5efa7e3f67d0	1
358917	benzoyl peroxide 5 % / clindamycin 1 % Topical Gel	SY	b7ba182e-4e36-4ea5-b9bb-5efa7e3f67d0	1
308694	benzoyl peroxide 5 % Topical Gel	SY	b7ba182e-4e36-4ea5-b9bb-5efa7e3f67d0	1
2676585	clindamycin (as clindamycin phosphate) 1 % Twice-Daily Topical Gel	SY	b7ba182e-4e36-4ea5-b9bb-5efa7e3f67d0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
21922-068-46	21922006846	1 KIT in 1 CARTON (21922-068-46) * 20 g in 1 JAR (21922-067-62) * 40 g in 1 JAR (21922-067-41) * 28 g in 1 BOTTLE, PUMP (21922-067-39) * 40 g in 1 BOTTLE, PUMP (21922-067-42) * 10 g in 1 BOTTLE (21922-066-12) * 7 g in 1 BOTTLE (21922-066-37) * 5 g in 1 BOTTLE (21922-066-36)	1 kit	2025-10-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clindamycin and Benzoyl Peroxide	Encube Ethicals, Inc.	2025-10-07	HUMAN PRESCRIPTION DRUG LABEL	1