Home NDC 0023-3670 ACZONE
Product NDC 0023-3670
11-digit product format 000233670
Labeler code 0023
Product ID 0023-3670_dfe068d3-6b3f-428a-9471-21287cada2a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dapsone
Dosage form GEL
Route TOPICAL
Labeler Allergan, Inc.
Application NDA021794
Marketing category NDA
Marketing start 2009-06-24
Marketing end 0000-00-00
Substance DAPSONE
Active strength 50 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 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 N021794-001 ACZONE DAPSONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021794-001 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 RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0023-3670 ACZONE (DAPSONE) GEL [ALLERGAN, INC.] 15 Legacy NDC, 8 package rows 20221124_b7d605cf-bf84-461b-939b-1f773a4cba65.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DAPSONE DAPSONE Pacific Pharma, Inc. 8dbe1a41-6d9d-414f-aa9c-09bd95857e2a 2018-09-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 021794 application number: NDA021794
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0023-3670-03 00023367003 15 TUBE in 1 CARTON (0023-3670-03) > 3 g in 1 TUBE 15 tube 2009-06-24 0000-00-00 No No Current 0023-3670-30 00023367030 1 TUBE in 1 CARTON (0023-3670-30) > 30 g in 1 TUBE 1 tube 2009-06-24 0000-00-00 No No Current 0023-3670-60 00023367060 1 TUBE in 1 CARTON (0023-3670-60) > 60 g in 1 TUBE 1 tube 2009-06-24 0000-00-00 No No Current 0023-3670-90 00023367090 1 TUBE in 1 CARTON (0023-3670-90) > 90 g in 1 TUBE 1 tube 2009-06-24 0000-00-00 No No Current