Aczone

Product NDC: 16110-526
11-digit product format: 161100526
Labeler code: 16110
Product ID: 16110-526_fee319ef-b2af-415e-8e91-32aaccc024da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dapsone
Dosage form: GEL
Route: TOPICAL
Labeler: Almirall, LLC
Application: NDA207154
Marketing category: NDA
Marketing start: 2019-09-10
Substance: DAPSONE
Active strength: 75 mg/g
Pharmacologic classes: Sulfone [EPC], Sulfones [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16110-526	16110-526-30	D	Discontinued by firm		2026-08-10

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	16110-526	16110-526-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207154-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207154-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207154-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207154-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207154-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207154-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207154-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207154-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207154-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207154-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207154-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207154-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207154-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207154-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207154-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207154-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207154-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207154-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207154-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207154-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207154-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207154-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207154-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207154-001	AB	1	`c0c555d07b60…`
2019-09-15 20:21 UTC	2019-09	N207154-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207154-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207154-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207154-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207154-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207154-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207154-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207154-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207154-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207154-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207154-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207154-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207154-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207154-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207154-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N207154-001	AB	1	`a50c72e98297…`

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207154-001	NPP	2022-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207154-001	NPP	2022-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207154-001	NPP	2022-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207154-001	NS	2019-02-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207154-001	NPP	2022-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N207154-001	NPP	2022-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207154-001	NPP	2022-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N207154-001	NPP	2022-09-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N207154-001	NPP	2022-09-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N207154-001	NPP	2022-09-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207154-001	NPP	2022-09-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207154-001	NS	2019-02-24	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207154-001	NPP	2022-09-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207154-001	NS	2019-02-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207154-001	NS	2019-02-24	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N207154-001	NPP	2022-09-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207154-001	NPP	2022-09-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207154-001	NPP	2022-09-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207154-001	NPP	2022-09-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207154-001	NPP	2022-09-10	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Aczone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DAPSONE	75 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8W5C518302	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1741905	Internal RxNorm lookup
1741907	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
22058b7d-a578-4eaa-a476-ac982337f02a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ae3f83f-9ccb-db71-5718-0b1e959868df	Product name	5	20260113
5ae2790a-f798-4a69-8811-64a4723c389a	Product name	5	20250325
b8929bfc-0002-d39a-046d-72ddf714efbe	Product name	6	20190618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16110-526-30	Aczone	1 in 1 CARTON	GEL	1	7
16110-526-30	Aczone	30 g in 1 BOTTLE, PUMP	GEL	30	7
16110-526-60	Aczone	60 g in 1 BOTTLE, PUMP	GEL	60	7
16110-526-60	Aczone	1 in 1 CARTON	GEL	1	7
16110-526-90	Aczone	1 in 1 CARTON	GEL	1	7
16110-526-90	Aczone	90 g in 1 BOTTLE, PUMP	GEL	90	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16110-526-30	GM - Gram	16110-526	247ac84a-2b50-4d74-9313-76e441a06760	1	2022-06-06
16110-526-60	GM - Gram	16110-526	14160d3f-86a2-4a75-9787-ddfc13950fb8	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16110-526	ACZONE (DAPSONE) GEL [ALMIRALL, LLC]	6	Current NDC, Legacy NDC, 6 package rows	20240424_22058b7d-a578-4eaa-a476-ac982337f02a.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
Aczone	DAPSONE	Almirall, LLC	22058b7d-a578-4eaa-a476-ac982337f02a	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 207154 application number: NDA207154 ndc (product): 16110-526

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8W5C518302	DAPSONE	80-08-0	DAPSONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1741907	Aczone 7.5 % Topical Gel	PSN	22058b7d-a578-4eaa-a476-ac982337f02a	7
1741905	dapsone 7.5 % Topical Gel	PSN	22058b7d-a578-4eaa-a476-ac982337f02a	7
1741907	dapsone 0.075 MG/MG Topical Gel [Aczone]	SBD	22058b7d-a578-4eaa-a476-ac982337f02a	7
1741905	dapsone 0.075 MG/MG Topical Gel	SCD	22058b7d-a578-4eaa-a476-ac982337f02a	7
1741907	Aczone 0.075 MG/MG Topical Gel	SY	22058b7d-a578-4eaa-a476-ac982337f02a	7
1741907	Aczone 7.5 % Topical Gel	SY	22058b7d-a578-4eaa-a476-ac982337f02a	7
1741905	dapsone 7.5 % Topical Gel	SY	22058b7d-a578-4eaa-a476-ac982337f02a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16110-526-30	16110052630	1 BOTTLE, PUMP in 1 CARTON (16110-526-30) > 30 g in 1 BOTTLE, PUMP	2019-09-10	0000-00-00	No	No	Current
16110-526-60	16110052660	1 BOTTLE, PUMP in 1 CARTON (16110-526-60) / 60 g in 1 BOTTLE, PUMP	2019-09-10	0000-00-00	No	No	Current
16110-526-90	16110052690	1 BOTTLE, PUMP in 1 CARTON (16110-526-90) / 90 g in 1 BOTTLE, PUMP	2019-09-10	0000-00-00	No	No	Current