TOENAIL FUNGUS / NAIL REPAIR PEN

Product NDC: 82743-101
11-digit product format: 827430101
Labeler code: 82743
Product ID: 82743-101_df745cf0-42bb-15a6-e053-2995a90ace62
Type: HUMAN OTC DRUG
Nonproprietary name: TEA TREE OIL
Dosage form: SOLUTION
Route: TOPICAL
Labeler: VITAL SYNERGY LLC
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2022-05-16
Marketing end: 0000-00-00
Substance: TEA TREE OIL
Active strength: 10 [hp_X]/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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	82743-101		I	Inactivated by FDA	2026-08-11
excluded package	package	82743-101	82743-101-30	I	Inactivated by FDA	2026-08-11
excluded package	package	82743-101	82743-101-63	I	Inactivated by FDA	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 · 45 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	82743-101-63	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82743-101-30	`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	82743-101-63	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82743-101-30	`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	82743-101-63	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82743-101-30	`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	82743-101-63	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82743-101-30	`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	82743-101-63	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82743-101-30	`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	82743-101-63	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82743-101-30	`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	82743-101-63	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82743-101-30	`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	82743-101-63	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82743-101-30	`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	82743-101-63	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82743-101-30	`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	82743-101-63	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	82743-101-30	`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	82743-101-63	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	82743-101-30	`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	82743-101-63	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	82743-101-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	82743-101-63	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	82743-101-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	82743-101-63	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	82743-101-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	82743-101-63	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	82743-101-30	`1332a3947898…`	`d4bfe170f9cd…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82743-101-30	2024-01-30	C162847	48780-1	1030e365-4e5f-111a-e063-dadaa90a10e2	VITAL SYNERGY - TOENAIL FUNGUS SOLUTION / NAIL REPAIR PEN (82743-101)
82743-101-63	2024-01-30	C162847	48780-1	1030e365-4e5f-111a-e063-dadaa90a10e2	VITAL SYNERGY - TOENAIL FUNGUS SOLUTION / NAIL REPAIR PEN (82743-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82743-101-01	TOENAIL FUNGUS / NAIL REPAIR PEN	30 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	30	3
82743-101-03	TOENAIL FUNGUS / NAIL REPAIR PEN	3 mL in 1 BOTTLE, WITH APPLICATOR	SOLUTION	3	3
82743-101-30	TOENAIL FUNGUS / NAIL REPAIR PEN	1 in 1 BOX	SOLUTION	1	3
82743-101-63	TOENAIL FUNGUS / NAIL REPAIR PEN	6 in 1 BOX	SOLUTION	6	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82743-101	TOENAIL FUNGUS / NAIL REPAIR PEN (TEA TREE OIL) SOLUTION [VITAL SYNERGY LLC]	3	Legacy NDC, 4 package rows	20220521_df28c13e-da4a-46c9-e053-2995a90a6597.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VIF565UC2G	TEA TREE OIL	68647-73-4	TEA TREE OIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82743-101-01	82743010101	30 mL in 1 BOTTLE, WITH APPLICATOR	30 ml					Historical
82743-101-03	82743010103	3 mL in 1 BOTTLE, WITH APPLICATOR	3 ml					Historical
82743-101-30	82743010130	1 BOTTLE, WITH APPLICATOR in 1 BOX (82743-101-30) > 30 mL in 1 BOTTLE, WITH APPLICATOR (82743-101-01)		2022-05-16	0000-00-00	No	No	Current
82743-101-63	82743010163	6 BOTTLE, WITH APPLICATOR in 1 BOX (82743-101-63) > 3 mL in 1 BOTTLE, WITH APPLICATOR (82743-101-03)		2022-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VITAL SYNERGY - TOENAIL FUNGUS SOLUTION / NAIL REPAIR PEN (82743-101)	VITAL SYNERGY LLC	2022-05-20	HUMAN OTC DRUG LABEL	3