Finacea

Product NDC: 10922-826
11-digit product format: 109220826
Labeler code: 10922
Product ID: 10922-826_a7594a20-f46e-4b33-91d5-410cc5e97b8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azelaic acid
Dosage form: KIT
Labeler: Intendis Inc.
Application: NDA021470
Marketing category: NDA
Marketing start: 2011-04-12
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	10922-826		I	Inactivated by FDA		2026-08-17
excluded package	package	10922-826	10922-826-10	I	Inactivated by FDA		2026-08-17

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10922-826-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10922-826-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10922-826-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10922-826-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10922-826-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10922-826-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10922-826-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10922-826-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10922-826-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10922-826-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10922-826-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10922-826-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10922-826-10	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10922-826-10	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10922-826-10	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10922-826-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10922-826-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10922-826-10	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10922-826-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10922-826-10	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10922-826-10	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10922-826-10	`110d247fa046…`	`a55b01930146…`

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
N021470-001	FINACEA	AZELAIC ACID	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021470-001	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	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021470-001	FINACEA	15%	GEL / TOPICAL	AB	RLD, RS	2002-12-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021470-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021470-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021470-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021470-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021470-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021470-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021470-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021470-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021470-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021470-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021470-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021470-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021470-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021470-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021470-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021470-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021470-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021470-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021470-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021470-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021470-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021470-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021470-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021470-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021470-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021470-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021470-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021470-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021470-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021470-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021470-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021470-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021470-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021470-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021470-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021470-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021470-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021470-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021470-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021470-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4b7700e3-6e0e-45e5-9d22-6f754d61386e	Product name	2	20250304
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
6c6fc281-9445-2e9e-1c29-a09ddbc4299c	Product name	2	20200213
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
2a856070-cbe7-4f85-be0f-09885ff91196	Product name	1	20150806

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10922-826-10	2019-11-27	C162847	48780-1	9855d018-d63a-cd31-e053-dbdaa90ab51a	Finacea ® (azelaic acid) Gel, 15%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10922-826-10	Finacea	1 in 1 CARTON	KIT	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10922-826-10	EA - Each	10922-826	5fc1cab0-2057-4585-a181-55457be4c4d2	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AZELAIC ACID	ACTIVE INGREDIENT	F2VW3D43YT	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
AZELAIC ACID	ACTIVE MOIETY	F2VW3D43YT	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
1,2-DIARACHIDOYL-SN-GLYCERO-3-PHOSPHOCHOLINE	INACTIVE INGREDIENT	HE0P2D9ZLS	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
BEHENTRIMONIUM METHOSULFATE	INACTIVE INGREDIENT	5SHP745C61	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
CERAMIDE 1	INACTIVE INGREDIENT	5THT33P7X7	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
CERAMIDE 3	INACTIVE INGREDIENT	4370DF050B	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
CERAMIDE 6 II	INACTIVE INGREDIENT	F1X8L2B00J	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
HYALURONIC ACID	INACTIVE INGREDIENT	S270N0TRQY	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
PHYTOSPHINGOSINE	INACTIVE INGREDIENT	GIN46U9Q2Q	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
POLYACRYLIC ACID (250000 MW)	INACTIVE INGREDIENT	9G2MAD7J6W	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
POLYGLYCERYL-3 DIISOSTEARATE	INACTIVE INGREDIENT	46P231IQV8	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
POTASSIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	CI71S98N1Z	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
POTASSIUM PHOSPHATE, UNSPECIFIED FORM	INACTIVE INGREDIENT	B7862WZ632	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
SODIUM LAUROYL LACTYLATE	INACTIVE INGREDIENT	7243K85WFO	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10922-826	FINACEA (AZELAIC ACID) GEL FINACEA (AZELAIC ACID) KIT [INTENDIS INC.]	5	Legacy NDC, 1 package rows	20130507_63773349-0295-4d56-a72e-0d7cade88ddb.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
Azelaic Acid Gel	AZELAIC ACID	Sandoz Inc.	66178511-5c1a-4ecd-bc98-2ceb54e710ac	2021-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021470 application number: NDA021470

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F2VW3D43YT	AZELAIC ACID	123-99-9	azelaic acid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1041518	azelaic acid 15 % Topical Gel	PSN	63773349-0295-4d56-a72e-0d7cade88ddb	5
1043748	Finacea 15 % Topical Gel	PSN	63773349-0295-4d56-a72e-0d7cade88ddb	5
1043748	azelaic acid 0.15 MG/MG Topical Gel [Finacea]	SBD	63773349-0295-4d56-a72e-0d7cade88ddb	5
1041518	azelaic acid 0.15 MG/MG Topical Gel	SCD	63773349-0295-4d56-a72e-0d7cade88ddb	5
1041518	azelaic acid 15 % Topical Gel	SY	63773349-0295-4d56-a72e-0d7cade88ddb	5
1043748	Finacea 0.15 MG/MG Topical Gel	SY	63773349-0295-4d56-a72e-0d7cade88ddb	5
1043748	Finacea 15 % Topical Gel	SY	63773349-0295-4d56-a72e-0d7cade88ddb	5
1043748	Finacea Plus (azelaic acid 0.15 MG/MG) Topical Gel	SY	63773349-0295-4d56-a72e-0d7cade88ddb	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10922-826-10	10922082610	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Finacea ® (azelaic acid) Gel, 15%	Intendis Inc. \| Intendis Manufacturing SPA	2011-04-12	HUMAN PRESCRIPTION DRUG LABEL	5