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

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

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 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