Home DailyMed 9ca01665-fb37-47f6-b4ff-cf1a7557bd73 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:19:53 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 88 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 2026-10-15 13:18:30 2026-09 N050819-001 ACANYA 2.5%;EQ 1.2% BASE GEL / TOPICAL AB RLD, RS 2008-10-23 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 ONEXTON 3.75%;EQ 1.2% BASE GEL / TOPICAL AB RLD, RS 2014-11-24 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 67 observed states.
Observed Orange Book patent history# Patent history page 1 of 21 · 832 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N050819-001 10220049 2029-06-03 U-916 Drug product 2019-03-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-001 10624918 2029-06-03 U-916 2020-05-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-001 8663699 2029-06-03 U-124 2014-03-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-001 8895070 2029-06-03 U-124 2015-05-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-001 9078870 2029-06-03 Drug product 2015-10-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-001 8288434 2029-08-05 U-124 Drug product 2012-10-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 10137142 2029-06-03 U-916 Drug product 2018-11-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 10220049 2029-06-03 U-916 Drug product 2019-03-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 9504704 2029-06-03 U-134 Drug product 2016-12-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 9504704 2029-06-03 U-818 Drug product 2016-12-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 9504704 2029-06-03 U-916 Drug product 2016-12-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 9504704 2029-06-03 U-124 Drug product 2016-12-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 9561208 2029-06-03 U-916 Drug product 2017-02-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 8288434 2029-08-05 U-818 Drug product 2014-12-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 8288434 2029-08-05 U-124 Drug product 2014-12-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 8288434 2029-08-05 U-134 Drug product 2014-12-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 8288434 2029-08-05 U-1033 Drug product 2014-12-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 8288434 2029-08-05 U-921 Drug product 2014-12-03 c2088c7a36db…2026-10-15 13:18:30 2026-09 N050819-002 8288434 2029-08-05 U-916 Drug product 2014-12-03 c2088c7a36db…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…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.