AZELEX

Product NDC: 0023-8694
11-digit product format: 000238694
Labeler code: 0023
Product ID: 0023-8694_cafd9e33-4b13-48f0-bb02-c14886266b4f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azelaic acid
Dosage form: CREAM
Route: CUTANEOUS
Labeler: Allergan, Inc.
Application: NDA020428
Marketing category: NDA
Marketing start: 1996-03-21
Marketing end: 0000-00-00
Substance: AZELAIC ACID
Active strength: 0 g/g
Pharmacologic classes: Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0023-8694		D	Discontinued by firm	2026-08-11
excluded package	package	0023-8694	0023-8694-30	D	Discontinued by firm	2026-08-11
excluded package	package	0023-8694	0023-8694-50	D	Discontinued by firm	2026-08-11

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 · 36 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	0023-8694-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0023-8694-50	`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	0023-8694-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0023-8694-50	`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	0023-8694-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0023-8694-50	`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	0023-8694-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0023-8694-50	`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	0023-8694-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0023-8694-50	`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	0023-8694-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0023-8694-50	`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	0023-8694-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0023-8694-50	`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	0023-8694-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0023-8694-50	`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	0023-8694-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0023-8694-50	`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	0023-8694-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0023-8694-50	`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	0023-8694-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0023-8694-50	`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	0023-8694-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0023-8694-50	`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
N020428-001	AZELEX	AZELAIC ACID	20%	CREAM / TOPICAL		RLD, RS	1995-09-13

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0023-8694-30	GM - Gram	0023-8694	984b2708-768a-4b40-8485-f43840b13a44	1	2013-02-13
0023-8694-50	GM - Gram	0023-8694	9c7604d2-c197-44fb-98a5-5e7eb2067382	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
azelaic acid	ACTIVE INGREDIENT	F2VW3D43YT	AZELEX (AZELAIC ACID) CREAM [ALLERGAN, INC.]	5
azelaic acid	ACTIVE MOIETY	F2VW3D43YT	AZELEX (AZELAIC ACID) CREAM [ALLERGAN, INC.]	5
benzoic acid	INACTIVE INGREDIENT	8SKN0B0MIM	AZELEX (AZELAIC ACID) CREAM [ALLERGAN, INC.]	5
cetearyl ethylhexanoate	INACTIVE INGREDIENT	9M64UO4C25	AZELEX (AZELAIC ACID) CREAM [ALLERGAN, INC.]	5
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	AZELEX (AZELAIC ACID) CREAM [ALLERGAN, INC.]	5
cetyl palmitate	INACTIVE INGREDIENT	5ZA2S6B08X	AZELEX (AZELAIC ACID) CREAM [ALLERGAN, INC.]	5
coco-glycerides	INACTIVE INGREDIENT	ISE9I7DNUG	AZELEX (AZELAIC ACID) CREAM [ALLERGAN, INC.]	5
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	AZELEX (AZELAIC ACID) CREAM [ALLERGAN, INC.]	5
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	AZELEX (AZELAIC ACID) CREAM [ALLERGAN, INC.]	5
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	AZELEX (AZELAIC ACID) CREAM [ALLERGAN, INC.]	5
water	INACTIVE INGREDIENT	059QF0KO0R	AZELEX (AZELAIC ACID) CREAM [ALLERGAN, INC.]	5
azelaic acid	ACTIVE INGREDIENT	F2VW3D43YT	AZELEX (AZELAIC ACID) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
azelaic acid	ACTIVE MOIETY	F2VW3D43YT	AZELEX (AZELAIC ACID) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
benzoic acid	INACTIVE INGREDIENT	8SKN0B0MIM	AZELEX (AZELAIC ACID) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
cetearyl ethylhexanoate	INACTIVE INGREDIENT	9M64UO4C25	AZELEX (AZELAIC ACID) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	AZELEX (AZELAIC ACID) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
cetyl palmitate	INACTIVE INGREDIENT	5ZA2S6B08X	AZELEX (AZELAIC ACID) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
coco-glycerides	INACTIVE INGREDIENT	ISE9I7DNUG	AZELEX (AZELAIC ACID) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	AZELEX (AZELAIC ACID) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	AZELEX (AZELAIC ACID) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	AZELEX (AZELAIC ACID) CREAM [PHYSICIANS TOTAL CARE, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	AZELEX (AZELAIC ACID) CREAM [PHYSICIANS TOTAL CARE, INC.]	1

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
AZELEX	AZELAIC ACID	Almirall, LLC	ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75	2024-03-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020428 application number: NDA020428

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
1041520	azelaic acid 20 % Topical Cream	PSN	0d5269d5-6555-4d2c-bc3b-df862b014275	1
1043753	Azelex 20 % Topical Cream	PSN	0d5269d5-6555-4d2c-bc3b-df862b014275	1
1043753	azelaic acid 200 MG/ML Topical Cream [Azelex]	SBD	0d5269d5-6555-4d2c-bc3b-df862b014275	1
1041520	azelaic acid 200 MG/ML Topical Cream	SCD	0d5269d5-6555-4d2c-bc3b-df862b014275	1
1041520	azelaic acid 20 % Topical Cream	SY	0d5269d5-6555-4d2c-bc3b-df862b014275	1
1043753	Azelex 20 % Topical Cream	SY	0d5269d5-6555-4d2c-bc3b-df862b014275	1
1043753	Azelex 200 MG/ML Topical Cream	SY	0d5269d5-6555-4d2c-bc3b-df862b014275	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AZELEX ® ( azelaic acid cream ) 20% For Dermatologic Use Only Not for Ophthalmic Use	Allergan, Inc.	2019-12-09	HUMAN PRESCRIPTION DRUG LABEL	8
AZELEX® (azelaic acid cream) 20%	Physicians Total Care, Inc.	2012-06-11	HUMAN PRESCRIPTION DRUG LABEL	1