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 95 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUSCLE	MENTHOL	WATER-JEL TECHNOLOGIES	1af399af-07b0-4899-9bcc-1e244b63b1cf	2025-04-08	Warnings	Exact identifier application number: M017
Lidocaine with Menthol	LIDOCAINE HCL AND MENTHOL	Kareway Product, Inc.	9ee46a5b-d00c-4254-e053-2995a90aeb3a	2025-04-08	Warnings	Exact identifier application number: M017
Foster and Thrive Lidocaine Pain Relief Patch	LIDOCAINE 4%	Strategic Sourcing Services LLC	324802c9-e2c2-bf74-e063-6394a90a8697	2025-04-08	Warnings	Exact identifier application number: M017
OARS AND ALPS MUSCLE RECOVERY BALM	MENTHOL, METHYL SALICYLATE	Cosco International, Inc	8745802f-018d-4cf8-bbf3-3b04c8f54538	2025-04-08	Warnings	Exact identifier application number: M017
NOVUM APR	MENTHOL	NOVUM SOLUTIONS INC	1b869a1f-5787-4d03-a546-43a8217b2b2c	2025-04-07	Warnings	Exact identifier application number: M017
MAG 5 PT ROLL-ON PAIN RELIEF COOLING	MENTHOL	RENU LABORATORIES, LLC	31e4fa2c-3a98-d618-e063-6394a90aec1c	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	cc7cbf4a-8274-e463-e053-2995a90a51e0	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	bdee018a-2c3c-3116-e053-2a95a90ac8d8	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce FIERY HOT PAIN RELIEF	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Implus Footcare, LLC	bdee2b65-2759-0e62-e053-2a95a90a0378	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce ICY COLD PAIN RELIEF	MENTHOL	Implus Footcare, LLC	bdc7c7f3-ac98-8fe9-e053-2a95a90a2663	2025-04-07	Warnings	Exact identifier application number: M017
RockSauce ICY COLD PAIN RELIEF	MENTHOL	Implus Footcare, LLC	bd4fdff1-9174-31c2-e053-2a95a90a749f	2025-04-07	Warnings	Exact identifier application number: M017
GREEN GUARD Topical Pain Relief	LIDOCAINE HCI	Ultra Distributors Inc	b6f0041c-47fc-0bcd-e053-2a95a90ab1f9	2025-04-07	Warnings	Exact identifier application number: M017
CBD Clinic Pain Relief - Level 5	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0ebc1c6-93fb-efd6-e053-2995a90a25bb	2025-04-07	Warnings	Exact identifier application number: M017
CBD Clinic Pain Relief - Level 4	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0e9ac7c-a840-2e05-e053-2a95a90a33f1	2025-04-07	Warnings	Exact identifier application number: M017
CBDMEDIC Active Sport Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec5f47-2f8e-0558-e053-2a95a90aa7ca	2025-04-07	Warnings	Exact identifier application number: M017
Hot Cold Medicated Patches	HOT COLD MEDICATED PATCHES	Henan Enokon Medical Instrument Co., Ltd.	159266a8-94fa-e2ff-e063-6394a90a9a77	2025-04-02	Warnings	Exact identifier application number: M017
Pain Relief Patch	PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	1592d29d-e275-a44d-e063-6294a90ab17d	2025-04-02	Warnings	Exact identifier application number: M017
Jointflex	CAMPHOR	Strides Consumer LLC	766b73f2-67bd-4d5c-805c-1057b3981ebf	2025-04-02	Warnings	Exact identifier application number: M017
Olu Pain Management	LIDOCAINE AND CAMPHOR	Asclemed USA, Inc.	d4d556c1-b64b-4b8e-8e4b-4f40eda24250	2025-04-01	Warnings	Exact identifier application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine Salicylate	TROLAMINE SALICYLATE	TELEBRANDS CORP	31ce185e-07b7-d837-e063-6394a90a1fb0	2025-04-01	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