FDA.reportPublic FDA data

Lidocaine Menthol Pain Relief

Product NDC
46122-574
11-digit product format
461220574
Labeler code
46122
Product ID
46122-574_52bfc22f-31a6-034f-e063-6394a90ab7d0
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Amerisource Bergen
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-01
Substance
LIDOCAINE; 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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS For External use only. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. ■over raw surfaces or blistered areas If pregnant or breast feeding ask a health professional before use. WHEN USING: avoid contact with the eyes do not use more than one patch on your body at a time Stop use and consult a doctor if skin irritation develops condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Menthol Pain Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100g
MENTHOL, UNSPECIFIED FORM1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987, L7T10EIP3A
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-574-212022-12-16C16284748780-1d6a99b39-6a78-a426-e053-dadaa90af4c2Lidocaine Menthol Pain Relief
46122-574-212022-12-16C16284748780-1d6a99b39-6a78-a426-e053-dadaa90af4c2Lidocaine Menthol Pain Relief
46122-574-212022-12-16C16284748780-1d6a99b39-6a78-a426-e053-dadaa90af4c2Lidocaine Menthol Pain Relief
46122-574-212022-01-28C16284748780-1d6a99b39-6a78-a426-e053-dadaa90af4c2Lidocaine Menthol Pain Relief
46122-574-212022-01-28C16284748780-1d6a99b39-6a78-a426-e053-dadaa90af4c2Lidocaine Menthol Pain Relief
46122-574-212022-01-28C16284748780-1d6a99b39-6a78-a426-e053-dadaa90af4c2Lidocaine Menthol Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-574-21Lidocaine Menthol Pain Relief5 in 1 POUCHPATCH56
46122-574-21Lidocaine Menthol Pain Relief8 g in 1 PATCHPATCH86

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-574-21EA - Each46122-574d0641140-ebee-423f-adf0-986f8bc6562812020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-574LIDOCAINE MENTHOL PAIN RELIEF (LIDOCAINE, MENTHOL) PATCH [AMERISOURCE BERGEN]3Current NDC, Legacy NDC, 2 package rows20241220_94039190-dde3-4d8e-873a-79abd3f6208b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN94039190-dde3-4d8e-873a-79abd3f6208b6
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD94039190-dde3-4d8e-873a-79abd3f6208b6
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY94039190-dde3-4d8e-873a-79abd3f6208b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-574-21461220574215 PATCH in 1 POUCH (46122-574-21) / 8 g in 1 PATCH5 patch2018-07-010000-00-00NoNoCurrent