Zylotrol

Product NDC: 76420-145
11-digit product format: 764200145
Labeler code: 76420
Product ID: 76420-145_07cebfba-4f3b-882f-e063-6294a90ac460
Type: HUMAN OTC DRUG
Nonproprietary name: Lidocaine HCl 4%, Menthol 1%
Dosage form: GEL
Route: TOPICAL
Labeler: Asclemed USA, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-06-12
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: 2027-12-31
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: 2027-12-31

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
e13984ea-73a9-2894-e053-2995a90a8ed6	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76420-145-04	Zylotrol	1 in 1 BOX	GEL	1		3
76420-145-04	Zylotrol	118.3 g in 1 TUBE	GEL	118.3		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-145-04	ML - Milliliter	76420-145	304a6a5c-65f1-4b11-9127-1dd4eaa6a34d	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-145	ZYLOTROL (LIDOCAINE HCL 4%, MENTHOL 1%) GEL [ASCLEMED USA, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20231016_e13984ea-73a9-2894-e053-2995a90a8ed6.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 130 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LidoReal Patch	LIDOCAINE AND MENTHOL	FORREAL PHARMACEUTICALS LLC	19f1c037-b4b8-47b0-b0f9-036691c1d307	2024-07-05	Warnings	Exact identifier application number: M017
Lip Medex Lip Balm	PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL	Blistex Inc.	988f97e8-a59f-4bc0-9d71-60607364a686	2024-07-01	Warnings	Exact identifier application number: M017
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM	MENTHOL	L'Oreal USA Products Inc	d580982f-dda6-4b03-bf84-342b9f2c6d93	2024-06-29	Warnings	Exact identifier application number: M017
Lip Medex Cherry	PETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORM	Blistex Inc.	fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af8	2024-06-28	Warnings	Exact identifier application number: M017
10% Methyl Salicylate Pain Relief Patch	10% METHYL SALICYLATE	Akron Coating & Adhesives	1be1f1ce-3238-a8ed-e063-6294a90a5aed	2024-06-27		Exact identifier application number: M017
Genuine First Aid Alcohol Cleansing Pad	BENZOCAINE, ALCOHOL	GFA Production (Xiamen) Co., Ltd.	c39c4d80-9718-459f-8ae4-ada043bba5b7	2024-06-26	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	1bd5cf69-9a08-5e2e-e063-6394a90a03cd	2024-06-26	Warnings	Exact identifier application number: M017
Solarcaine Burn Pain Relief 4oz	SOLARCAINE BURN PAIN RELIEF 4OZ	WellSpring Pharmaceutical Corporation	2c0389db-ceb2-422b-9575-bdb8fe649a1e	2024-06-26	Warnings	Exact identifier application number: M017
astonea	HYDROCORTISONE	ASTONEA LABS PRIVATE LIMITED	de09e859-c5fd-0cc5-e053-2a95a90a147e	2024-06-25	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	0190196d-5f78-042b-e063-6294a90a3714	2024-06-25	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	1bc1bf83-91ee-ec9d-e063-6394a90a3daf	2024-06-25	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	1bc2f688-d0c4-690e-e063-6294a90abc38	2024-06-25	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil	MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	1b9fdac0-9fb0-e669-e063-6394a90aece9	2024-06-24	Warnings	Exact identifier application number: M017
Capsaicin	CAPSAICIN	Asclemed USA, Inc.	97d506bd-3215-4e2e-9914-af1c174dd4ab	2024-06-20	Warnings	Exact identifier application number: M017
ABREVA Rapid Pain Relief	GLYCERIN, LIDOCAINE	Haleon US Holdings LLC	65bd242f-4c6a-436c-8ec0-7b2e0d73ed9d	2024-06-20	Warnings	Exact identifier application number: M017
Frankie Avalons ZERO PAIN Roll-On Pain Reliever	CAPSAICIN	WHY ENTERPRISES LLC	e32acb5f-5bc3-4228-b037-6315d080f556	2024-06-17	Warnings	Exact identifier application number: M017
PUREGEN LABS Pain Relief 4 Lidocaine	LIDOCAINE	Advanced Rx LLC	9dff40d8-8d7e-4629-bea5-987f5e68477d	2024-06-11	Warnings	Exact identifier application number: M017
SMOOTH GATOR Head-Ezz Analgesic	MENTHOL	Smooth Gator LLC	02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd	2024-06-10	Warnings	Exact identifier application number: M017
FIRST AID BURN	LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE	Epic Medical Supply Corp	bd1b1873-e900-45eb-96a0-28f782b5a7cd	2024-06-04	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Chain Drug Marketing Association Inc.	1c834ba0-86b6-8e61-e063-6394a90a192d	2024-06-04	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	e13984ea-73a9-2894-e053-2995a90a8ed6	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	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
76420-145-04	76420014504	1 TUBE in 1 BOX (76420-145-04) / 118.3 g in 1 TUBE	1 tube	2022-06-12	0000-00-00	No	No	Current