Arazlo

Product NDC: 0187-2098
11-digit product format: 001872098
Labeler code: 0187
Product ID: 0187-2098_06456968-fe83-2c27-e063-6294a90af3ea
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tazarotene
Dosage form: LOTION
Route: TOPICAL
Labeler: Bausch Health US, LLC
Application: NDA211882
Marketing category: NDA
Marketing start: 2019-12-19
Substance: TAZAROTENE
Active strength: .45 mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
N211882-001	ARAZLO	TAZAROTENE	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211882-001	11679116	2036-06-06		Drug product	2023-07-13
N211882-001	11311482	2038-05-11	U-2368		2022-05-05
N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08

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.

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	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL	AB	RLD, RS	2019-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211882-001	ARAZLO	0.045%	LOTION / TOPICAL		RLD, RS	2019-12-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N211882-001	AB	1	`6a471c1ec25d…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211882-001	12128137	2038-05-11	U-2368	Drug product	2024-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211882-001	11679116	2036-06-06		Drug product	2023-07-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211882-001	11311482	2038-05-11	U-2368		2022-05-05	`5c6f7cd8ea54…`
2020-12-22 03:56 UTC	2020-12	N211882-001	6517847	2020-08-03	U-2368	Drug product	2020-01-08	`8869cabd3fbd…`

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	N211882-001	NP	2022-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211882-001	NP	2022-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211882-001	NP	2022-12-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211882-001	NP	2022-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211882-001	NP	2022-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211882-001	NP	2022-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211882-001	NP	2022-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211882-001	NP	2022-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211882-001	NP	2022-12-18	`c0c555d07b60…`
2023-01-26 05:58 UTC	2023-01	N211882-001	NP	2022-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211882-001	NP	2022-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211882-001	NP	2022-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211882-001	NP	2022-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211882-001	NP	2022-12-18	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TAZAROTENE	.45 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
81BDR9Y8PS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2267561	Internal RxNorm lookup
2267566	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
d941ff25-c221-4a55-8012-0dcf3bbcbbd1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6	Product name	2	20260220
5993ea1b-833d-fa4b-caad-a0d477537538	Product name	5	20250305
c24b0f4e-b27e-8e2b-a129-1b5a6d72c459	Product name	2	20231128
18da2240-e326-4d63-90cd-d6bb15f662a0	Product name	1	20200604
a32b252c-8cd2-cc4a-c64c-4b9d3916df9e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0187-2098-03	Arazlo	3 g in 1 TUBE	LOTION	3	5
0187-2098-10	Arazlo	10 in 1 CARTON	LOTION	10	5
0187-2098-45	Arazlo	1 in 1 CARTON	LOTION	1	5
0187-2098-45	Arazlo	45 g in 1 TUBE	LOTION	45	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-2098-45	GM - Gram	0187-2098	efb1f42b-e0ba-4e86-b84e-91a30bf1417f	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-2098	ARAZLO (TAZAROTENE) LOTION [BAUSCH HEALTH US, LLC]	5	Current NDC, Legacy NDC, 4 package rows	20230927_d941ff25-c221-4a55-8012-0dcf3bbcbbd1.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
Arazlo	TAZAROTENE	Bausch Health US, LLC	d941ff25-c221-4a55-8012-0dcf3bbcbbd1	2023-09-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211882 application number: NDA211882 ndc (product): 0187-2098

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
81BDR9Y8PS	TAZAROTENE	118292-40-3	TAZAROTENE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2267566	ARAZLO 0.045 % Topical Lotion	PSN	d941ff25-c221-4a55-8012-0dcf3bbcbbd1	5
2267561	tazarotene 0.045 % Topical Lotion	PSN	d941ff25-c221-4a55-8012-0dcf3bbcbbd1	5
2267566	tazarotene 0.45 MG/ML Topical Lotion [Arazlo]	SBD	d941ff25-c221-4a55-8012-0dcf3bbcbbd1	5
2267561	tazarotene 0.45 MG/ML Topical Lotion	SCD	d941ff25-c221-4a55-8012-0dcf3bbcbbd1	5
2267566	Arazlo 0.045 % Topical Lotion	SY	d941ff25-c221-4a55-8012-0dcf3bbcbbd1	5
2267561	tazarotene 0.045 % Topical Lotion	SY	d941ff25-c221-4a55-8012-0dcf3bbcbbd1	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-2098-03	00187209803	3 g in 1 TUBE	3 g					Historical
0187-2098-10	00187209810	10 TUBE in 1 CARTON (0187-2098-10) / 3 g in 1 TUBE (0187-2098-03)	10 tube	2019-12-19	0000-00-00	Yes	No	Current
0187-2098-45	00187209845	1 TUBE in 1 CARTON (0187-2098-45) / 45 g in 1 TUBE	1 tube	2019-12-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Arazlo	Bausch Health US, LLC \| Bausch Health Companies Inc.	2023-09-26	HUMAN PRESCRIPTION DRUG LABEL	5