LenzaGel

Product NDC: 53217-026
11-digit product format: 532170026
Labeler code: 53217
Product ID: 53217-026_bcc54b4f-bf01-40dc-82e3-633f8bb1054a
Type: HUMAN OTC DRUG
Nonproprietary name: LIDOCAINE HYDROCHLORIDE, MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Aidarex Pharmaceuticals LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-03-01
Marketing end: 0000-00-00
Substance: LIDOCAINE HYDROCHLORIDE; MENTHOL
Active strength: 4 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53217-026		I	Inactivated by FDA		2026-10-05
excluded package	package	53217-026	53217-026-01	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 1 · 42 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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`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	53217-026-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53217-026-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53217-026-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53217-026-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53217-026-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53217-026-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53217-026-01	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-026-01	2020-01-31	C162847	48780-1	9d75b9d0-ff85-f424-e053-dadaa90a57ce	LenzaGel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-026-01	LenzaGel	120 g in 1 BOTTLE, PLASTIC	GEL	120		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53217-026-01	GM - Gram	53217-026	614a802d-e894-4a51-9f75-e65165e8b4bc	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIDOCAINE HYDROCHLORIDE	ACTIVE INGREDIENT	V13007Z41A	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
LIDOCAINE	ACTIVE MOIETY	98PI200987	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
ARNICA MONTANA	INACTIVE INGREDIENT	O80TY208ZW	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
INDIAN FRANKINCENSE	INACTIVE INGREDIENT	4PW41QCO2M	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-026	LENZAGEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [AIDAREX PHARMACEUTICALS LLC]	3	Legacy NDC, 1 package rows	20140403_f52cc82a-e5fd-494a-942f-372e2eb46fcb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1373142	LenzaGel 4 % / 1 % Topical Gel	PSN	f52cc82a-e5fd-494a-942f-372e2eb46fcb	3
1373137	lidocaine HCl 4 % / menthol 1 % Topical Gel	PSN	f52cc82a-e5fd-494a-942f-372e2eb46fcb	3
1373142	lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lenzagel]	SBD	f52cc82a-e5fd-494a-942f-372e2eb46fcb	3
1373137	lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel	SCD	f52cc82a-e5fd-494a-942f-372e2eb46fcb	3
1373142	Lenzagel (lidocaine hydrochloride 4 % / menthol 1 % ) Topical Gel	SY	f52cc82a-e5fd-494a-942f-372e2eb46fcb	3
1373137	lidocaine hydrochloride 4 % / menthol 1 % Topical Gel	SY	f52cc82a-e5fd-494a-942f-372e2eb46fcb	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53217-026-01	53217002601	120 g in 1 BOTTLE, PLASTIC	120 g	Historical