Zylotrol

Product NDC: 81902-201
11-digit product format: 819020201
Labeler code: 81902
Product ID: 81902-201_07cf1076-0948-5b74-e063-6294a90a2396
Type: HUMAN OTC DRUG
Nonproprietary name: Lidocaine HCl 4%, Menthol 1%
Dosage form: GEL
Route: TOPICAL
Labeler: Whitestone Products LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-01-04
Substance: LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength: 4; 1 g/100g; g/100g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Zylotrol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE	4 g/100g
MENTHOL, UNSPECIFIED FORM	1 g/100g

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1373137	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
0e32e9c0-ff5b-4e88-89b1-f5903cd98209	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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	Strength	SPL version
81902-201-04	Zylotrol	118.3 g in 1 TUBE	GEL	118.3		3
81902-201-04	Zylotrol	1 in 1 BOX	GEL	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81902-201-04	GM - Gram	81902-201	62dab991-3aed-49ac-ae23-e0c9e8341ad9	2	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81902-201	ZYLOTROL (LIDOCAINE HCL 4%, MENTHOL 1%) GEL [WHITESTONE PRODUCTS LLC]	3	Current NDC, Legacy NDC, 2 package rows	20231016_0e32e9c0-ff5b-4e88-89b1-f5903cd98209.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 25 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LidoTape	LIDOCAINE 4%	V2 Pharma LLC	ed18b4f7-6a2c-4dce-9b53-e485569093c5	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Lidocaine Pain Relief	LIDOCAINE	Veridian Healthcare	4f112ab2-b67a-a3e2-e063-6394a90acb60	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Pain Relief	MENTHOL	Veridian Healthcare	4f11aa1e-de53-a3b0-e063-6294a90a2fe4	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare 2X Medicated Pain Relief	LIDOCAINE, MENTHOL	Veridian Healthcare	4f11fca1-1949-ab8e-e063-6394a90ac627	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Medicated Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	Veridian Healthcare	4f125062-af89-40d3-e063-6394a90a27ef	2026-04-09	Warnings	Exact identifier application number: M017
DRMITSUI ECZEMA RELIEF	HYDROCORTISONE 1% ECZEMA RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4eee7637-3a28-e0bd-e063-6294a90ae1a4	2026-04-08	Warnings	Exact identifier application number: M017
SINSIN MULPAS	L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR	Sinsin Pharmaceutical Co., Ltd.	47c077c2-6e34-8e7a-e063-6294a90a21b5	2026-04-08	Warnings	Exact identifier application number: M017
Yi Tiao Gen Pain Patch	PAIN PATCH	Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory	4828fe70-f6f8-45e4-9c9a-a9e486dc65e5	2026-04-07	Warnings	Exact identifier application number: M017
Dermatool Nerve Care	LIDOCAINE HCL, MENTHOL	Papalo Group, LLC	4ee40c96-9350-4c68-e063-6294a90ac812	2026-04-07	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	CVS Pharmacy, Inc.	42b3c341-f422-b2b4-e063-6294a90a47b2	2026-04-06	Warnings	Exact identifier application number: M017
KinetiCream Pain Relieving Topical Analgesic	MENTHOL	Phoenix Bioperformance Products LLC	bb4c9e73-e62d-4b8c-a16c-b90db1a8b2a7	2026-04-06	Warnings	Exact identifier application number: M017
KinetiCream Anti-Inflammatory and Pain Relief	MENTHOL	Phoenix Bioperformance Products LLC	39a6d26b-b5f4-45d7-a9b5-6edbf42d7500	2026-04-06	Warnings	Exact identifier application number: M017
Dr. Blue PainZaway Pain Relieving Roll-On	MENTHOL	Indiana Botanic Gardens	4ecc8241-5a87-2f45-e063-6294a90aa30a	2026-04-06	Warnings	Exact identifier application number: M017
Sunburn Relief Gel	LIDOCAINE HCL	CVS Pharmacy, Inc.	d7f52394-5cc1-48a6-ae89-9fc63b515758	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M017
Pain-Relieving Patch	CAMPHOR, MENTHOL, METHYL SALICYLATE	CVS Pharmacy	4ecf4a6e-5c0f-7943-e063-6394a90a81cc	2026-04-06	Warnings	Exact identifier application number: M017
RAPID RELIEF	0.025% CAPSAICIN PAIN PATCH	RAPID AID VIET NAM COMPANY LIMITED	4edbaa1a-6e44-4865-e063-6394a90a8cc3	2026-04-06	Warnings	Exact identifier application number: M017
Capsaicin 0.1% Cream	CAPSAICIN 0.1%	Puretek Corporation	4e83441b-cb6a-beb0-e063-6394a90a1b54	2026-04-03	Warnings	Exact identifier application number: M017
NeroCare Capsaicin Neuropathy Relief Cream	CAPSAICIN	Guangzhou Tata Biotechnology Co., Ltd.	4e89b7eb-0d84-dc57-e063-6394a90a7dd9	2026-04-03	Warnings	Exact identifier application number: M017
TheraCare Pain Relief Patch	LIDOCAINE 4%	Veridian Healthcare	4e91da65-8191-6261-e063-6394a90a6bd5	2026-04-03	Warnings	Exact identifier application number: M017
HealthWise Roll-On	LIDOCAINE, MENTHOL	Veridian Healthcare	4e9306b5-949e-f7a9-e063-6394a90ae13a	2026-04-03	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	0e32e9c0-ff5b-4e88-89b1-f5903cd98209	3
1373137	lidocaine HCl 4 % / menthol 1 % Topical Gel	PSN	e13984ea-73a9-2894-e053-2995a90a8ed6	3
1373137	lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel	SCD	0e32e9c0-ff5b-4e88-89b1-f5903cd98209	3
1373137	lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel	SCD	e13984ea-73a9-2894-e053-2995a90a8ed6	3
1373137	lidocaine hydrochloride 4 % / menthol 1 % Topical Gel	SY	0e32e9c0-ff5b-4e88-89b1-f5903cd98209	3
1373137	lidocaine hydrochloride 4 % / menthol 1 % Topical Gel	SY	e13984ea-73a9-2894-e053-2995a90a8ed6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81902-201-04	81902020104	1 TUBE in 1 BOX (81902-201-04) / 118.3 g in 1 TUBE	1 tube	2022-01-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zylotrol	Whitestone Products LLC	2023-10-16	HUMAN OTC DRUG LABEL	3
Zylotrol	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2023-10-16	HUMAN OTC DRUG LABEL	3