Home NDC 16110-367-60 ACZONE
Product NDC 16110-367
Requested package NDC 16110-367-60
11-digit product format 161100367
Labeler code 16110
Product ID 16110-367_4b6c672f-a7c3-4123-8f64-c08b3d7ae906
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dapsone
Dosage form GEL
Route TOPICAL
Labeler ALMIRALL, LLC
Application NDA021794
Marketing category NDA
Marketing start 2022-02-12
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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 16110-367 16110-367-60 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 2026-08-18 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…2022-09-29 23:25 UTC 2022-09 N021794-001 ACZONE 5% GEL / TOPICAL AB RLD, RS 2005-07-07 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 16110-367-60 2022-03-29 C162847 48780-1 d6a99b3a-00a4-a426-e053-dadaa90af4c2 These highlights do not include all the information needed to use ACZONE ® Gel, 5% safely and effectively. See full prescribing information for ACZONE ® Gel, 5% . ACZONE ® (dapsone) Gel, 5%, for topical use Initial U.S. Approval: 1955 16110-367-90 2022-03-29 C162847 48780-1 d6a99b3a-00a4-a426-e053-dadaa90af4c2 These highlights do not include all the information needed to use ACZONE ® Gel, 5% safely and effectively. See full prescribing information for ACZONE ® Gel, 5% . ACZONE ® (dapsone) Gel, 5%, for topical use Initial U.S. Approval: 1955
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16110-367 ACZONE (DAPSONE) GEL [ALMIRALL, LLC] 7 Legacy NDC 20240906_fc4ac90b-8962-4b9b-8c69-b1ea59d00009.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16110-367-60 16110036760 1 TUBE in 1 CARTON (16110-367-60) > 60 g in 1 TUBE 1 tube 2022-02-12 0000-00-00 No No Current