tavaborole

Product NDC: 51862-690
11-digit product format: 518620690
Labeler code: 51862
Product ID: 51862-690_12ed0433-3ec5-f721-e063-6294a90adc2b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tavaborole
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Mayne Pharma Commercial LLC
Application: ANDA211297
Marketing category: ANDA
Marketing start: 2021-02-01
Substance: TAVABOROLE
Active strength: 43.5 mg/mL
Pharmacologic classes: Boron Compounds [CS], Oxaborole Antifungal [EPC], Protein Synthesis Inhibitors [MoA]
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	51862-690	51862-690-10	D	Discontinued by firm		2026-08-03

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 · 2 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	51862-690	51862-690-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-690	51862-690-10	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A211297-001	TAVABOROLE	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211297-001	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.

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	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2020-10-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211297-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	RS	2020-10-13	`a50c72e98297…`

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	A211297-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211297-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211297-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211297-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211297-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211297-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211297-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211297-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211297-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211297-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211297-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211297-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211297-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211297-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211297-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211297-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211297-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211297-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211297-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211297-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211297-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211297-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211297-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211297-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211297-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211297-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211297-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211297-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211297-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211297-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211297-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211297-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211297-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211297-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211297-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211297-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A211297-001	PC	2021-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211297-001	PC	2021-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211297-001	PC	2021-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211297-001	PC	2021-04-17	`8869cabd3fbd…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TAVABOROLE	43.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K124A4EUQ3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1543177	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
7ad9dc39-7501-4db5-a935-d9be8eea30a6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
79fe69fe-2d2a-4706-b33c-c00838ac4ade	Product name	2	20240422

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51862-690-10	tavaborole	1 in 1 CARTON	SOLUTION	1		4
51862-690-10	tavaborole	10 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	10		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-690-10	ML - Milliliter	51862-690	32418161-e342-4284-a749-402874678473	1	2021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51862-690	TAVABOROLE SOLUTION [MAYNE PHARMA COMMERCIAL LLC]	4	Current NDC, Legacy NDC, 2 package rows	20240307_7ad9dc39-7501-4db5-a935-d9be8eea30a6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tavaborole	TAVABOROLE TOPICAL SOLUTION, 5%	Encube Ethicals, Inc.	050f5d10-5591-426e-9020-6516b3363304	2025-09-15	Adverse reactions	Exact identifier application applno (ANDA): 211297 application number: ANDA211297
tavaborole	TAVABOROLE	Mayne Pharma Commercial LLC	7ad9dc39-7501-4db5-a935-d9be8eea30a6	2024-03-05	Adverse reactions	Exact identifier application applno (ANDA): 211297 application number: ANDA211297 ndc (product): 51862-690

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K124A4EUQ3	TAVABOROLE	174671-46-6	TAVABOROLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1543177	tavaborole 5 % Topical Solution	PSN	7ad9dc39-7501-4db5-a935-d9be8eea30a6	4
1543177	tavaborole 43.5 MG/ML Topical Solution	SCD	7ad9dc39-7501-4db5-a935-d9be8eea30a6	4
1543177	tavaborole 5 % Topical Solution	SY	7ad9dc39-7501-4db5-a935-d9be8eea30a6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-690-10	51862069010	1 BOTTLE, WITH APPLICATOR in 1 CARTON (51862-690-10) > 10 mL in 1 BOTTLE, WITH APPLICATOR	2021-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
tavaborole	Mayne Pharma Commercial LLC \| Encube Ethicals Private Limited	2024-03-05	HUMAN PRESCRIPTION DRUG LABEL	4