LidoPatch

Product NDC: 50682-527
11-digit product format: 506820527
Labeler code: 50682
Product ID: 50682-527_dec971e0-6bec-4ae4-aec4-76c8ded82c47
Type: HUMAN OTC DRUG
Nonproprietary name: lidocaine and menthol
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: 3T Federal Solutions LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-02-01
Marketing end: 0000-00-00
Substance: LIDOCAINE; MENTHOL
Active strength: 40 mg/1; mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50682-527		I	Inactivated by FDA	2026-10-05
excluded package	package	50682-527	50682-527-03	I	Inactivated by FDA	2026-10-05
excluded package	package	50682-527	50682-527-07	I	Inactivated by FDA	2026-10-05
excluded package	package	50682-527	50682-527-30	I	Inactivated by FDA	2026-10-05

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 2 · 88 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	50682-527-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50682-527-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50682-527-07	`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	50682-527-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50682-527-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50682-527-07	`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	50682-527-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50682-527-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50682-527-07	`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	50682-527-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50682-527-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50682-527-07	`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	50682-527-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50682-527-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50682-527-07	`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	50682-527-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50682-527-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50682-527-07	`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	50682-527-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50682-527-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50682-527-07	`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	50682-527-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50682-527-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50682-527-07	`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	50682-527-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50682-527-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50682-527-07	`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	50682-527-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50682-527-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50682-527-07	`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	50682-527-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50682-527-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50682-527-07	`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	50682-527-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50682-527-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50682-527-07	`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	50682-527-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50682-527-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50682-527-07	`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	50682-527-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50682-527-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50682-527-07	`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	50682-527-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50682-527-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50682-527-07	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50682-527-03	2019-11-13	C162847	48780-1	97449f38-b909-f6ea-e053-dbdaa90aa703	LidoPatch™
50682-527-07	2019-11-13	C162847	48780-1	97449f38-b909-f6ea-e053-dbdaa90aa703	LidoPatch™
50682-527-30	2019-11-13	C162847	48780-1	97449f38-b909-f6ea-e053-dbdaa90aa703	LidoPatch™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50682-527-03	LidoPatchPain Relief	1 in 1 POUCH	PATCH	1	1
50682-527-03	LidoPatchPain Relief	3 in 1 CARTON	PATCH	3	1
50682-527-07	LidoPatchPain Relief	7 in 1 CARTON	PATCH	7	1
50682-527-07	LidoPatchPain Relief	1 in 1 POUCH	PATCH	1	1
50682-527-30	LidoPatchPain Relief	30 in 1 CARTON	PATCH	30	1
50682-527-30	LidoPatchPain Relief	1 in 1 POUCH	PATCH	1	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lidocaine	ACTIVE INGREDIENT	98PI200987	LIDOPATCH PAIN RELIEF (LIDOCAINE AND MENTHOL) PATCH [3T FEDERAL SOLUTIONS LLC]	1
menthol	ACTIVE INGREDIENT	L7T10EIP3A	LIDOPATCH PAIN RELIEF (LIDOCAINE AND MENTHOL) PATCH [3T FEDERAL SOLUTIONS LLC]	1
lidocaine	ACTIVE MOIETY	98PI200987	LIDOPATCH PAIN RELIEF (LIDOCAINE AND MENTHOL) PATCH [3T FEDERAL SOLUTIONS LLC]	1
menthol	ACTIVE MOIETY	L7T10EIP3A	LIDOPATCH PAIN RELIEF (LIDOCAINE AND MENTHOL) PATCH [3T FEDERAL SOLUTIONS LLC]	1
Acrylamide	INACTIVE INGREDIENT	20R035KLCI	LIDOPATCH PAIN RELIEF (LIDOCAINE AND MENTHOL) PATCH [3T FEDERAL SOLUTIONS LLC]	1
Diazolidinyl Urea	INACTIVE INGREDIENT	H5RIZ3MPW4	LIDOPATCH PAIN RELIEF (LIDOCAINE AND MENTHOL) PATCH [3T FEDERAL SOLUTIONS LLC]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	LIDOPATCH PAIN RELIEF (LIDOCAINE AND MENTHOL) PATCH [3T FEDERAL SOLUTIONS LLC]	1
Urea	INACTIVE INGREDIENT	8W8T17847W	LIDOPATCH PAIN RELIEF (LIDOCAINE AND MENTHOL) PATCH [3T FEDERAL SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50682-527	LIDOPATCH PAIN RELIEF (LIDOCAINE AND MENTHOL) PATCH [3T FEDERAL SOLUTIONS LLC]	1	Legacy NDC, 6 package rows	20120316_de85ffbf-c92d-4a5a-8b12-e6525f039ab3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1249758	lidocaine 4 % / menthol 1 % Medicated Patch	PSN	de85ffbf-c92d-4a5a-8b12-e6525f039ab3	1
1249763	LidoPatch 4 % / 1 % Medicated Patch	PSN	de85ffbf-c92d-4a5a-8b12-e6525f039ab3	1
1249763	lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [Lidopatch]	SBD	de85ffbf-c92d-4a5a-8b12-e6525f039ab3	1
1249758	lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch	SCD	de85ffbf-c92d-4a5a-8b12-e6525f039ab3	1
1249758	lidocaine 4 % / menthol 1 % Medicated Patch	SY	de85ffbf-c92d-4a5a-8b12-e6525f039ab3	1
1249763	LidoPatch (lidocaine 4 % / menthol 1 % ) Medicated Patch	SY	de85ffbf-c92d-4a5a-8b12-e6525f039ab3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50682-527-03	50682052703	1 in 1 POUCH	Historical
50682-527-07	50682052707	7 in 1 CARTON	Historical
50682-527-30	50682052730	30 in 1 CARTON	Historical