JUBLIA

Product NDC: 0187-5400
11-digit product format: 001875400
Labeler code: 0187
Product ID: 0187-5400_aa387108-3f36-49af-bbcb-df681d4b9e51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: efinaconazole
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Bausch Health US LLC
Application: NDA203567
Marketing category: NDA
Marketing start: 2014-06-06
Substance: EFINACONAZOLE
Active strength: 100 mg/mL
Pharmacologic classes: Azole Antifungal [EPC], Azoles [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	0187-5400	0187-5400-10	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N203567-001	JUBLIA	EFINACONAZOLE	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N203567-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203567-001	7214506	2026-02-22	U-281		2014-06-20
N203567-001	10512640	2028-01-03	U-1969		2020-01-08
N203567-001	10828369	2028-01-03		Drug product	2020-12-02
N203567-001	11213519	2028-01-03	U-2720		2022-01-20
N203567-001	11872218	2028-01-03	U-1969		2024-02-09
N203567-001	9566272	2028-01-03	U-1969		2017-02-22
N203567-001	9877955	2028-01-03	U-1969		2018-01-31
N203567-001	10105444	2030-07-08		Drug product	2018-10-24
N203567-001	8039494	2030-07-08	U-281		2014-06-20
N203567-001	9861698	2030-07-08		Drug product	2018-01-10
N203567-001	8486978	2030-10-24		Drug product	2014-06-20
N203567-001	9302009	2030-10-24		Drug product	2016-04-25
N203567-001	10342875	2034-10-02	U-2720	Drug product	2019-07-12
N203567-001	10828293	2034-10-02	U-2720		2020-12-02
N203567-001	10864274	2034-10-02	U-2720		2021-01-07
N203567-001	11654139	2034-10-02	U-1969		2023-06-14
N203567-001	9662394	2034-10-02		Drug product	2017-05-30
N203567-001	10478601	2035-04-25	U-2721	Drug product	2019-12-17

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	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL		RLD, RS	2014-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AT	RLD, RS	2014-06-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL		RLD, RS	2014-06-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL		RLD, RS	2014-06-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL		RLD, RS	2014-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL		RLD, RS	2014-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL		RLD, RS	2014-06-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203567-001	JUBLIA	10%	SOLUTION / TOPICAL	AB	RLD, RS	2014-06-06	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N203567-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203567-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203567-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203567-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203567-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203567-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203567-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203567-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203567-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203567-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203567-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203567-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203567-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203567-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203567-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203567-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203567-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203567-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N203567-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203567-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203567-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203567-001	AT	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203567-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203567-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203567-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203567-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203567-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203567-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203567-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203567-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203567-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203567-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203567-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203567-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203567-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N203567-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 674 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	N203567-001	7214506	2026-02-22	U-281		2014-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10512640	2028-01-03	U-1969		2020-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10828369	2028-01-03		Drug product	2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	11213519	2028-01-03	U-2720		2022-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	11872218	2028-01-03	U-1969		2024-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	9566272	2028-01-03	U-1969		2017-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	9877955	2028-01-03	U-1969		2018-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10105444	2030-07-08		Drug product	2018-10-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	8039494	2030-07-08	U-281		2014-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	9861698	2030-07-08		Drug product	2018-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	8486978	2030-10-24		Drug product	2014-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	9302009	2030-10-24		Drug product	2016-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10342875	2034-10-02	U-2720	Drug product	2019-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10828293	2034-10-02	U-2720		2020-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10864274	2034-10-02	U-2720		2021-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	11654139	2034-10-02	U-1969		2023-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	9662394	2034-10-02		Drug product	2017-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N203567-001	10478601	2035-04-25	U-2721	Drug product	2019-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N203567-001	7214506	2026-02-22	U-281		2014-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10512640	2028-01-03	U-1969		2020-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10828369	2028-01-03		Drug product	2020-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	11213519	2028-01-03	U-2720		2022-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	11872218	2028-01-03	U-1969		2024-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	9566272	2028-01-03	U-1969		2017-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	9877955	2028-01-03	U-1969		2018-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10105444	2030-07-08		Drug product	2018-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	8039494	2030-07-08	U-281		2014-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	9861698	2030-07-08		Drug product	2018-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	8486978	2030-10-24		Drug product	2014-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	9302009	2030-10-24		Drug product	2016-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10342875	2034-10-02	U-2720	Drug product	2019-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10828293	2034-10-02	U-2720		2020-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10864274	2034-10-02	U-2720		2021-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	11654139	2034-10-02	U-1969		2023-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	9662394	2034-10-02		Drug product	2017-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203567-001	10478601	2035-04-25	U-2721	Drug product	2019-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203567-001	7214506	2026-02-22	U-281		2014-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203567-001	10512640	2028-01-03	U-1969		2020-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203567-001	10828369	2028-01-03		Drug product	2020-12-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203567-001	11213519	2028-01-03	U-2720		2022-01-20	`31067a03dcf5…`

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	N203567-001	NPP	2023-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203567-001	NPP	2023-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203567-001	NPP	2023-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203567-001	NCE	2019-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203567-001	NPP	2023-04-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203567-001	NPP	2023-04-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203567-001	NPP	2023-04-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203567-001	NPP	2023-04-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203567-001	NPP	2023-04-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203567-001	NPP	2023-04-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203567-001	NCE	2019-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203567-001	NCE	2019-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203567-001	NCE	2019-06-06	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N203567-001	NPP	2023-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203567-001	NPP	2023-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203567-001	NPP	2023-04-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203567-001	NPP	2023-04-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203567-001	NPP	2023-04-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203567-001	NPP	2023-04-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203567-001	NPP	2023-04-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203567-001	NPP	2023-04-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203567-001	NPP	2023-04-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203567-001	NPP	2023-04-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203567-001	NPP	2023-04-27	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EFINACONAZOLE	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J82SB7FXWB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1539757	Internal RxNorm lookup
1539762	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
922d4d25-c530-11e1-9b21-0800200c9a66	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e1c84cbe-2b36-41da-b08d-31bc95241cd1	Product name	3	20220118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0187-5400-02	JUBLIA	2 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	2	21
0187-5400-02	JUBLIA	1 in 1 CARTON	SOLUTION	1	21
0187-5400-04	JUBLIA	1 in 1 CARTON	SOLUTION	1	21
0187-5400-04	JUBLIA	4 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	4	21
0187-5400-08	JUBLIA	8 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	8	21
0187-5400-08	JUBLIA	1 in 1 CARTON	SOLUTION	1	21
0187-5400-10	JUBLIA	4 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	4	21
0187-5400-10	JUBLIA	1 in 1 CARTON	SOLUTION	1	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-5400-04	ML - Milliliter	0187-5400	29516e7c-1d1f-4ef7-a561-bca4a4e4b352	1	2014-07-02
0187-5400-08	ML - Milliliter	0187-5400	a849e5d8-e2e6-41ea-b1b6-a38f4f52bfe8	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EFINACONAZOLE	ACTIVE INGREDIENT	J82SB7FXWB	JUBLIA (EFINACONAZOLE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
EFINACONAZOLE	ACTIVE MOIETY	J82SB7FXWB	JUBLIA (EFINACONAZOLE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	JUBLIA (EFINACONAZOLE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	JUBLIA (EFINACONAZOLE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	JUBLIA (EFINACONAZOLE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
C12-15 ALKYL LACTATE	INACTIVE INGREDIENT	GC844VRD7E	JUBLIA (EFINACONAZOLE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	JUBLIA (EFINACONAZOLE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
DIISOPROPYL ADIPATE	INACTIVE INGREDIENT	P7E6YFV72X	JUBLIA (EFINACONAZOLE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	JUBLIA (EFINACONAZOLE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	JUBLIA (EFINACONAZOLE) SOLUTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0187-5400	JUBLIA (EFINACONAZOLE) SOLUTION [BAUSCH HEALTH US LLC]	20	Current NDC, Legacy NDC, 8 package rows	20220728_922d4d25-c530-11e1-9b21-0800200c9a66.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
JUBLIA	EFINACONAZOLE	Bausch Health US LLC	922d4d25-c530-11e1-9b21-0800200c9a66	2025-07-01	Adverse reactions	Exact identifier application applno (NDA): 203567 application number: NDA203567 ndc (product): 0187-5400

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J82SB7FXWB	EFINACONAZOLE	164650-44-6	EFINACONAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1539757	efinaconazole 10 % Topical Solution	PSN	922d4d25-c530-11e1-9b21-0800200c9a66	21
1539762	JUBLIA 10 % Topical Solution	PSN	922d4d25-c530-11e1-9b21-0800200c9a66	21
1539762	efinaconazole 100 MG/ML Topical Solution [Jublia]	SBD	922d4d25-c530-11e1-9b21-0800200c9a66	21
1539757	efinaconazole 100 MG/ML Topical Solution	SCD	922d4d25-c530-11e1-9b21-0800200c9a66	21
1539757	efinaconazole 10 % Topical Solution	SY	922d4d25-c530-11e1-9b21-0800200c9a66	21
1539762	Jublia 10 % Topical Solution	SY	922d4d25-c530-11e1-9b21-0800200c9a66	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0187-5400-02	00187540002	1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) / 2 mL in 1 BOTTLE, WITH APPLICATOR		2015-12-17	0000-00-00	No	No	Current
0187-5400-04	00187540004	1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) / 4 mL in 1 BOTTLE, WITH APPLICATOR		2014-06-06	0000-00-00	No	No	Current
0187-5400-08	00187540008	1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-08) / 8 mL in 1 BOTTLE, WITH APPLICATOR		2014-06-06	0000-00-00	No	No	Current
0187-5400-10	00187540010	4 mL in 1 BOTTLE, WITH APPLICATOR	4 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
JUBLIA	Bausch Health US LLC \| Kaken Pharmaceutical Co., Ltd. \| Bausch Health Companies Inc.	2025-07-01	HUMAN PRESCRIPTION DRUG LABEL	21