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		2026-10-21

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 102 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FORTHiQ Pain Relief Lidocaine Patch	PAIN RELIEF LIDOCAINE PATCH	Henan Enokon Medical Instrument Co., Ltd.	2c593420-5788-3422-e063-6394a90a1890	2025-01-22	Warnings	Exact identifier application number: M017
RETALIEF LIDOCAINE 5	LIDOCAINE	Reliable 1 Laboratories LLC	2c262f3c-8cb2-4384-e063-6294a90a436d	2025-01-20	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	1c3e5068-dd61-ebdb-e063-6294a90a97cc	2025-01-20	Warnings	Exact identifier application number: M017
PROHEAL BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab1	2025-01-19	Warnings	Exact identifier application number: M017
HERSTAT PLUS Cold Sore Treatment	CAMPHOR, MENTHOL	Herstat (USA) Inc.	e20ea714-663d-c4ac-e053-2a95a90a5ecc	2025-01-18	Warnings	Exact identifier application number: M017
Pain Relief Medicated	CAMPHOR MENTHOL METHYL SALICYTATE	RITE AID CORPORATION	60895211-69f3-478b-a33f-1c2071f62950	2025-01-16	Warnings	Exact identifier application number: M017
Elgin Pain Relief	MENTHOL	Eco-Logics, Inc.	70eda21e-e566-42f4-9a49-b0d3ad000652	2025-01-16	Warnings	Exact identifier application number: M017
Curist Lidocaine Patch Maximum Strength	LIDOCAINE	Little Pharma, Inc.	e574c188-cc65-287d-e053-2995a90a5972	2025-01-16	Warnings	Exact identifier application number: M017
Equate Hydrocortisone Topical	HYDROCORTISONE	WalMart	1f64555d-f77e-4a83-b222-fdb3ed7d8853	2025-01-16	Warnings	Exact identifier application number: M017
Equate Hydrocortisone	HYDROCORTISONE	WalMart	f5c32b4a-1159-4b7a-b8ac-256d53020dc2	2025-01-16	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	296fcc36-563f-19ca-e063-6394a90ab3ae	2025-01-15	Warnings	Exact identifier application number: M017
K19 RELIEF	MENTHOL	K19 LLC	e2e1ca96-1ae8-4c99-b8de-ce26754292f9	2025-01-15	Warnings	Exact identifier application number: M017
Anecream	LIDOCAINE 4%	Focus Health Group	2d7706e2-7363-4047-96cb-85b718277e8c	2025-01-15	Warnings	Exact identifier application number: M017
Boroleum	CAMPHOR, MENTHOL, WHITE PETROLATUM	Reliable 1 Laboratories	846568af-0fdd-a80e-e053-2a91aa0a9c9e	2025-01-15	Warnings	Exact identifier application number: M017
LidoPro Pain Relief	CAPSAICIN AND LIDOCAINE	Advanced Rx of Tennessee, LLC	27d5997b-1cc2-41c2-e063-6394a90ac74a	2025-01-15	Warnings	Exact identifier application number: M017
Pain Relief Patch 4% Lidocaine	LIDOCAINE	Reliable 1 Laboratories LLC	2b624763-c310-63d9-e063-6394a90a1928	2025-01-15	Warnings	Exact identifier application number: M017
Cannarelief 1000mg	MENTHOL	Carolina Cannabis Creations LLC	01e2ae1a-c969-6dd2-e063-6394a90a9d9e	2025-01-15	Warnings	Exact identifier application number: M017
Healing Hand Cream 2000mg	MENTHOL	Carolina Cannabis Creations LLC	01f8795b-9f95-c793-e063-6394a90a8330	2025-01-15	Warnings	Exact identifier application number: M017
CBD Clinic Deep-Rub Pain Relief - Level 5	CAMPHOR, MENTHOL	ABACUS HEALTH PRODUCTS, INC.	31e2e5cd-d33e-f058-e063-6394a90af7d2	2025-01-14	Warnings	Exact identifier application number: M017
Meijer Odor Free Analgesic Pain Relieving Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	6288efea-f636-4eea-bb9f-78aa2f9af54a	2025-01-14	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