FDA.reportPublic FDA data

4% lidocaine plus 1% menthol Pain Relief Patch

Product NDC
85323-003
11-digit product format
853230003
Labeler code
85323
Product ID
85323-003_3d3bf989-ea47-406f-e063-6294a90a816a
Type
HUMAN OTC DRUG
Nonproprietary name
Pain Relief Patch, Pain Relief Strip
Dosage form
PATCH
Route
TOPICAL
Labeler
Xuzhou Lanting Pharmaceutical Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-01
Substance
LEVOMENTHOL; LIDOCAINE HYDROCHLORIDE
Active strength
1; 4 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

Additional Listing Data#

Finished product
Yes
Brand name base
4% lidocaine plus 1% menthol Pain Relief Patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOMENTHOL1 g/100g
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBZ1R15MTK7, V13007Z41A
Rxcui1249758

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
85323-003-004% lidocaine plus 1% menthol Pain Relief Patch1 in 1 POUCHPATCH14
85323-003-004% lidocaine plus 1% menthol Pain Relief Patch5 in 1 BOXPATCH54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85323-0034% LIDOCAINE PLUS 1% MENTHOL PAIN RELIEF PATCH (PAIN RELIEF PATCH, PAIN RELIEF STRIP) PATCH [XUZHOU LANTING PHARMACEUTICAL CO., LTD]1Current NDC, 2 package rows20250326_2f98ee5e-e4eb-fbda-e063-6394a90a709c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN2f98ee5e-e4eb-fbda-e063-6394a90a709c4
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD2f98ee5e-e4eb-fbda-e063-6394a90a709c4
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY2f98ee5e-e4eb-fbda-e063-6394a90a709c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85323-003-00853230003005 POUCH in 1 BOX (85323-003-00) / 1 PATCH in 1 POUCH / 12 g in 1 PATCH5 pouch2025-03-01NoNoHistorical