Lidozen

Product NDC: 63187-892
11-digit product format: 631870892
Labeler code: 63187
Product ID: 63187-892_de5d688d-8c71-4bf5-999c-17a3f323f854
Type: HUMAN OTC DRUG
Nonproprietary name: LIDOCAINE HYDROCHLORIDE, MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Proficient Rx LP
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-07-22
Substance: LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength: 40; 10 mg/mL; mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
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	63187-892	63187-892-64	D	Discontinued by firm		2026-10-23

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Lidozen
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	40 mg/mL
MENTHOL, UNSPECIFIED FORM	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V13007Z41A	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1373137	Internal RxNorm lookup
1939340	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
1ebb45e5-4541-4c95-abe1-661ef763a610	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
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
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63187-892-64	Lidozen	120 mL in 1 BOTTLE	GEL	120	8
63187-892-64	Lidozen	2 in 1 BOX	GEL	2	8
63187-892-72	Lidozen	120 mL in 1 BOTTLE	GEL	120	8
63187-892-72	Lidozen	1 in 1 BOX	GEL	1	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-892-64	ML - Milliliter	63187-892	25d9fcac-9517-4481-a303-b53caae753b7	1	2021-02-05
63187-892-72	ML - Milliliter	63187-892	d8290353-b1db-4b54-9b2d-5642f12be407	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-892	LIDOZEN (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [PROFICIENT RX LP]	8	Current NDC, Legacy NDC, 4 package rows	20231118_1ebb45e5-4541-4c95-abe1-661ef763a610.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 150 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Assured	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutic Al Co., Ltd.	bc97f364-9443-47b8-9c2d-b5dcc00cc9b7	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	b41091b4-0dc0-4a88-8ff6-11979b3d307a	2023-10-25	Warnings	Exact identifier application number: M017
Thera Plus	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	bcc99e5a-2403-46da-9c9d-8411fa4104e0	2023-10-25	Warnings	Exact identifier application number: M017
Assured	LIDOCAINE HYDROCHLORIDE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c	2023-10-25	Warnings	Exact identifier application number: M017
Red hot	CAPSAICIN	The Hygenic Company, LLC	d100092c-e10b-2063-e053-2995a90aedb2	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	c8d4ae28-efc4-6a00-e053-2a95a90a40bf	2023-10-25	Warnings	Exact identifier application number: M017
Cryo10 Topical Analgesic	MENTHOL	Element 26 LLC	ff1d2140-9302-918c-e053-6394a90acb9a	2023-10-25	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL	Troy Manufacturing, Inc.	3336cc35-e773-4705-84b5-61040604beef	2023-10-25	Warnings	Exact identifier application number: M017
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant	BENZOCAINE, WHITE PETROLATUM	Carma Laboratories, Inc.	bbf0abcd-b7d6-b5e4-e053-2995a90a5240	2023-10-25	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	bbee66b9-39ff-4e7e-e053-2995a90a43be	2023-10-25	Warnings	Exact identifier application number: M017
XtraCare Ice Cold Topical Analgesic Gel	MENTHOL	Rejoice International	d38f3099-d940-44d8-aa7f-404157c5e0e3	2023-10-24	Warnings	Exact identifier application number: M017
Family Wellness	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	fefbe351-1cd9-4a2f-a43d-51e2c4eb180b	2023-10-24	Warnings	Exact identifier application number: M017
TheraPlus Plus	MENTHOL	Zhejiang Jingwei Pharmaceutical Co., Ltd.	d4119f84-eb60-4134-b58e-de13d9601199	2023-10-24	Warnings	Exact identifier application number: M017
Family Wellness	HYDROCORTISONE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	cddc9c4a-7c58-4225-921a-05d6afb49178	2023-10-24	Warnings	Exact identifier application number: M017
NUMOTIZINE	MENTHOL	Hobart Laboratories, Inc.	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	2023-10-20	Warnings	Exact identifier application number: M017
Numfast Tetracaine Green	TETRACAINE	Unit Dose, Ltd.	77d9e6ea-1cd3-4447-ba74-01cd7143e27c	2023-10-19	Warnings	Exact identifier application number: M017
Liprotek	PETROLATUM, LIDOCAINE	Unit Dose, Ltd.	051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa5	2023-10-19	Warnings	Exact identifier application number: M017
GENUINE FIRST AID Antiseptic Pain Relieving	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	bc7c6739-6068-4694-adc9-0c0c5c347df4	2023-10-19	Warnings	Exact identifier application number: M017
CVS Itch relief moisturizing	PRAMOXINE HCL 1%	CVS Health	f3a753fc-f448-6bba-e053-2a95a90a8e1b	2023-10-18	Warnings	Exact identifier application number: M017
Zylotrol	LIDOCAINE HCL 4%, MENTHOL 1%	Asclemed USA, Inc.	e13984ea-73a9-2894-e053-2995a90a8ed6	2023-10-16	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	LIDOCAINE HYDROCHLORIDE
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1373137	lidocaine HCl 4 % / menthol 1 % Topical Gel	PSN	1ebb45e5-4541-4c95-abe1-661ef763a610	8
1939340	LidozenGel 4 % / 1 % Topical Gel	PSN	1ebb45e5-4541-4c95-abe1-661ef763a610	8
1939340	lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen]	SBD	1ebb45e5-4541-4c95-abe1-661ef763a610	8
1373137	lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel	SCD	1ebb45e5-4541-4c95-abe1-661ef763a610	8
1373137	lidocaine hydrochloride 4 % / menthol 1 % Topical Gel	SY	1ebb45e5-4541-4c95-abe1-661ef763a610	8
1939340	Lidozen 4 % / 1 % Topical Gel	SY	1ebb45e5-4541-4c95-abe1-661ef763a610	8
1939340	LidozenGel 4 % / 1 % Topical Gel	SY	1ebb45e5-4541-4c95-abe1-661ef763a610	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-892-64	63187089264	2 BOTTLE in 1 BOX (63187-892-64) > 120 mL in 1 BOTTLE	2 bottle	2020-11-13	0000-00-00	No	No	Current
63187-892-72	63187089272	1 BOTTLE in 1 BOX (63187-892-72) / 120 mL in 1 BOTTLE	1 bottle	2017-08-01	0000-00-00	No	No	Current