Tavaborole Topical Solution

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-12-06
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 21:18:56

Label at a glance#

ProductTavaborole

Active ingredientTAVABOROLE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1826-0

Tavaborole topical solution, 5%

10 mL

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1543177	tavaborole 5 % Topical Solution	PSN	2
1543177	tavaborole 43.5 MG/ML Topical Solution	SCD	2
1543177	tavaborole 5 % Topical Solution	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
TAVABOROLE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
70771-1826-0	Tavaborole	1 in 1 CARTON	SOLUTION	1		2
70771-1826-0	Tavaborole	10 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1826	TAVABOROLE SOLUTION [ZYDUS LIFESCIENCES LIMITED]	2	Current NDC, 2 package rows	20241208_15bc62dc-4f5e-4d43-a125-d1f00bee84a5.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Tavaborole
ALCOHOL
EDETATE CALCIUM DISODIUM
PROPYLENE GLYCOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1826	70771-1826-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TAVABOROLE	K124A4EUQ3	ACTIB
ALCOHOL	3K9958V90M	IACT
EDETATE CALCIUM DISODIUM	25IH6R4SGF	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A212294-001	TAVABOROLE	TAVABOROLE	5%	SOLUTION / TOPICAL	AB		2023-04-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212294-001	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	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212294-001	TAVABOROLE	5%	SOLUTION / TOPICAL	AB	2023-04-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A212294-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212294-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212294-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212294-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212294-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212294-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212294-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212294-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212294-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212294-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212294-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212294-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212294-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212294-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212294-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212294-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212294-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212294-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212294-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212294-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212294-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212294-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212294-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212294-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212294-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212294-001	AB	1	`a50c72e98297…`

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
Tavaborole	TAVABOROLE	Zydus Lifesciences Limited	15bc62dc-4f5e-4d43-a125-d1f00bee84a5	2024-12-06		Exact identifier ndc (package): 70771-1826-0 ndc (product): 70771-1826 ndc11 (package): 70771182600 spl id: b7ea9baf-cd2b-4430-a0cf-85945ce38a17 spl set id: 15bc62dc-4f5e-4d43-a125-d1f00bee84a5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.