FDA.reportPublic FDA data

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
IngredientStrength
LIDOCAINE HYDROCHLORIDE4 g/100g
MENTHOL, UNSPECIFIED FORM1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1373137Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e32e9c0-ff5b-4e88-89b1-f5903cd98209Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81902-201-04Zylotrol118.3 g in 1 TUBEGEL118.33
81902-201-04Zylotrol1 in 1 BOXGEL13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81902-201-04GM - Gram81902-20162dab991-3aed-49ac-ae23-e0c9e8341ad922023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81902-201ZYLOTROL (LIDOCAINE HCL 4%, MENTHOL 1%) GEL [WHITESTONE PRODUCTS LLC]3Current NDC, Legacy NDC, 2 package rows20231016_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 7 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SatogesicDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.cb000134-92a4-4304-8ef0-0347190e14142026-07-31WarningsExact identifier
application number: M017
Satogesic HotCAPSAICINSato Pharmaceutical Co., Ltd.16b47cb5-ea5f-4514-9a89-141ee4cc60f82026-07-31WarningsExact identifier
application number: M017
Satohap Cool and Hot PadsCAMPHOR, CAPSAICIN, MENTHOLSato Pharmaceutical Co., Ltd.b6bf1eab-4ab9-f500-e053-2995a90a8d7b2026-07-31Warnings, Adverse reactionsExact identifier
application number: M017
SATOHAP COOL and HOTCAMPHOR, CAPSAICIN, MENTHOLSato Pharmaceuticals Co., Ltd.232a4c76-1a0c-2f4b-e063-6394a90a88492026-07-31Warnings, Adverse reactionsExact identifier
application number: M017
Cortizone 10 Itch Relief Massaging RollerballHYDROCORTISONEChattem, Inc.1e27682c-f856-41f1-9935-37540960a4c72026-07-31WarningsExact identifier
application number: M017
Aspercreme with Lidocaine DryLIDOCAINEChattem, Inc.008abaaa-5e12-4246-a7f5-66f3966acf282026-07-30WarningsExact identifier
application number: M017
ACOLYE Lidocaine Cream Topical Analgesia CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd57deebf7-52f1-4256-e063-6294a90a75d52026-07-30WarningsExact identifier
application number: M017
Icy Hot Performance No-Mess Pain Relief CreamMENTHOL 16%, CAMPHOR 11%Chattem, Inc.5e3e272a-c001-4f57-9535-521ccc85ae652026-07-30WarningsExact identifier
application number: M017
Auixudin Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.57bc7b9e-e2f7-724b-e063-6394a90ab36f2026-07-29WarningsExact identifier
application number: M017
Jinfahe Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.57bcd9c5-767e-b634-e063-6394a90a28782026-07-29WarningsExact identifier
application number: M017
Maximun Strength Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLMeijer Distribution Incd0468514-58ea-4d8f-b634-a65bf95c03162026-07-29WarningsExact identifier
application number: M017
Oudetas Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.57ca9220-2778-790a-e063-6294a90af5062026-07-29WarningsExact identifier
application number: M017
Aspercreme Lidocaine No-Mess plus LavenderLIDOCAINE HCLChattem, Inc.3948a3d2-ce04-4703-8709-211e75c9c38d2026-07-29WarningsExact identifier
application number: M017
Aspercreme Professional CreamLIDOCAINE HCL 4%Chattem, Inc.ef297864-5917-4645-8ec7-f2bc49e037e82026-07-29WarningsExact identifier
application number: M017
LidoProLIDOCAINE AND MENTHOLClinic Pharmacdfd6b39-b430-4e95-a0f7-682cf3d78b522026-07-28WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHClinic Pharma2b4d2105-b7ad-2695-e063-6394a90a999b2026-07-28WarningsExact identifier
application number: M017
HEMPE Ice Muscle and Joint GelMENTHOLHealthcare International Research Limited57aec922-1de4-c579-e063-6394a90af6c82026-07-28WarningsExact identifier
application number: M017
Earths Care Pain RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEDLC Laboratories, Inc.5c3976da-a6cb-4b94-ae41-3e86b1ab13cb2026-07-28WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Preferred Pharmaceuticals Inc.9e7568b6-52ae-4f7a-9bfd-503fd80a297e2026-07-28WarningsExact identifier
application number: M017
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373137lidocaine HCl 4 % / menthol 1 % Topical GelPSN0e32e9c0-ff5b-4e88-89b1-f5903cd982093
1373137lidocaine HCl 4 % / menthol 1 % Topical GelPSNe13984ea-73a9-2894-e053-2995a90a8ed63
1373137lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD0e32e9c0-ff5b-4e88-89b1-f5903cd982093
1373137lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCDe13984ea-73a9-2894-e053-2995a90a8ed63
1373137lidocaine hydrochloride 4 % / menthol 1 % Topical GelSY0e32e9c0-ff5b-4e88-89b1-f5903cd982093
1373137lidocaine hydrochloride 4 % / menthol 1 % Topical GelSYe13984ea-73a9-2894-e053-2995a90a8ed63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81902-201-04819020201041 TUBE in 1 BOX (81902-201-04) / 118.3 g in 1 TUBE1 tube2022-01-040000-00-00NoNoCurrent