Home NDC 13548-132 Acanya
Product NDC 13548-132
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 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Active strength 25; 10 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.
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.
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.
DailyMed Product Concepts# 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 Socrata Ingredients# 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.
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