FDA.reportPublic FDA data

Lidothol Patch

Product NDC
72189-553
11-digit product format
721890553
Labeler code
72189
Product ID
72189-553_4d27ed91-6bf5-c483-e063-6294a90a37ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidothol Patch
Dosage form
PATCH
Route
TOPICAL
Labeler
Direct_Rx
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-05-28
Marketing end
2027-05-31
Substance
LIDOCAINE; MENTHOL
Active strength
4; 1 mg/100mg; mg/100mg
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidothol Patch

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 mg/100mg
MENTHOL1 mg/100mg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-553-15Lidothol Patch15 mg in 1 PATCHPATCH152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-553-15EA - Each72189-553d21dea10-402f-4a7c-ad0f-7446a15d9ef912024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-553LIDOTHOL PATCH PATCH [DIRECT_RX]1Current NDC, 1 package rows20240530_1987e839-6f4e-8671-e063-6394a90abea6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN1987e839-6f4e-8671-e063-6394a90abea62
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD1987e839-6f4e-8671-e063-6394a90abea62
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY1987e839-6f4e-8671-e063-6394a90abea62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-553-157218905531515 mg in 1 PATCH (72189-553-15) 15 mg2024-05-282027-05-31NoNoHistorical