Home NDC 0023-5206-60 ACZONE
Product NDC 0023-5206
Requested package NDC 0023-5206-60
11-digit product format 000235206
Labeler code 0023
Product ID 0023-5206_a355f6ab-62c2-4ec3-828f-177b660e6684
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dapsone
Dosage form GEL
Route TOPICAL
Labeler Allergan, Inc.
Application NDA207154
Marketing category NDA
Marketing start 2016-02-26
Marketing end 0000-00-00
Substance DAPSONE
Active strength 75 mg/g
Pharmacologic classes Sulfone [EPC], Sulfones [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N207154-001 ACZONE DAPSONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N207154-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N207154-001 11273132 2033-11-18 Drug product 2022-03-28
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N207154-001 ACZONE 7.5% GEL / TOPICAL RLD, RS 2016-02-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N207154-001 ACZONE 7.5% GEL / TOPICAL AB RLD, RS 2016-02-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 3 · 90 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207154-001 11273132 2033-11-18 Drug product 2022-03-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N207154-001 9161926 2033-11-18 Drug product 2016-03-01 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N207154-001 9517219 2033-11-18 U-1033 2016-12-16 5aa47cf7b7d7…
Observed Orange Book exclusivity history# 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 Aczone DAPSONE Almirall, LLC 22058b7d-a578-4eaa-a476-ac982337f02a 2025-10-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 207154 application number: NDA207154
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0023-5206-60 00023520660 1 BOTTLE, PUMP in 1 CARTON (0023-5206-60) > 60 g in 1 BOTTLE, PUMP 2016-02-26 0000-00-00 No No Current