FDA.reportPublic FDA data

ZYLOTROL MAXIMUM PAIN

Product NDC
76420-581
11-digit product format
764200581
Labeler code
76420
Product ID
76420-581_0831d32f-b4cd-6e8b-e063-6294a90a38b8
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine 4%, menthol 1%
Dosage form
PATCH
Route
TOPICAL
Labeler
Asclemed USA, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-23
Substance
LIDOCAINE; MENTHOL
Active strength
.12; .03 g/3g; g/3g
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

Additional Listing Data#

Finished product
Yes
Brand name base
ZYLOTROL MAXIMUM PAIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.12 g/3g
LIDOCAINE.03 g/3g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1249758Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91ddAvailable 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
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
76420-581-15ZYLOTROL MAXIMUM PAIN15 in 1 BOXPATCH152
76420-581-15ZYLOTROL MAXIMUM PAIN3 g in 1 PATCHPATCH32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-581-15EA - Each76420-58175cec7b3-0113-4815-b531-04d1884c56bf12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-581ZYLOTROL MAXIMUM PAIN (LIDOCAINE 4%, MENTHOL 1%) PATCH [ASCLEMED USA, INC.]2Current NDC, 2 package rows20231021_0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYLOTROL MAXIMUM PAINLIDOCAINE 4%, MENTHOL 1%Asclemed USA, Inc.0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd2023-10-20WarningsExact identifier
ndc (product): 76420-581

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd2
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd2
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-581-157642005811515 PATCH in 1 BOX (76420-581-15) / 3 g in 1 PATCH15 patch2023-06-07NoNoCurrent