FDA.reportPublic FDA data

Lidozen Patch

Product NDC
71205-745
11-digit product format
712050745
Labeler code
71205
Product ID
71205-745_4c0346a9-a4b3-4217-9b8c-f08470d3dfb7
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE, MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
Proficient Rx LP
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-01
Substance
LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength
40; 10 mg/g; mg/g
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Lidozen Patch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g
MENTHOL, UNSPECIFIED FORM10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1249758Internal RxNorm lookup
2201504Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0df4b8b-2679-4652-9144-a8db916a186bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-745-05Lidozen Patch5 in 1 BOXPATCH52
71205-745-05Lidozen Patch1 g in 1 PATCHPATCH12
71205-745-15Lidozen Patch1 g in 1 PATCHPATCH12
71205-745-15Lidozen Patch15 in 1 BOXPATCH152
71205-745-30Lidozen Patch30 in 1 BOXPATCH302
71205-745-30Lidozen Patch1 g in 1 PATCHPATCH12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-745-05EA - Each71205-745f40ee53c-accd-40e6-bb9e-ef761013a89912023-06-06
71205-745-15EA - Each71205-745def4b0d4-b44f-4f69-acc9-af54debeeee412023-06-06
71205-745-30EA - Each71205-745021a4bfb-7629-457b-b3a4-b48621726c4112023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-745LIDOZEN PATCH (LIDOCAINE, MENTHOL) PATCH [PROFICIENT RX LP]2Current NDC, 6 package rows20231207_c0df4b8b-2679-4652-9144-a8db916a186b.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 145 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDETheraplex Solutionsa898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d42023-11-10WarningsExact identifier
application number: M017
SUPER BLUE STUFF Pain Relief CreamMENTHOLBLUE SPRING WELLNESS, L.L.C.066a2106-2e25-4df6-9a8d-4417ba1902052023-11-10WarningsExact identifier
application number: M017
INVIGO FLEX Pain Relief GelMENTHOLWYNNPHARM INC.909e1d8c-c517-4d6a-8682-894f042c00f82023-11-10WarningsExact identifier
application number: M017
ARNIMAX Penetrating Pain Relief GelMENTHOLWYNNPHARM INC.3a31f805-19c6-4036-a663-ebef9b2120072023-11-10WarningsExact identifier
application number: M017
KERA HCHYDROCORTISONEClinical Therapeutic Solutionsac215c8f-b224-480c-9295-3a34316293ba2023-11-10WarningsExact identifier
application number: M017
ALO THERAPEUTIC MASSAGE PAIN RELIEVINGMENTHOL, HISTAMINE DIHYDROCHLORIDETheraplex Solutionsda004500-5e48-487b-b96f-520a3094096c2023-11-10WarningsExact identifier
application number: M017
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVINGMENTHOL, METHYL SALICYLATERexall Sundown, LLC55c55f1c-d2b3-6363-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
NEUROFLEX Topical Pain Relieving LiquidCAMPHOR (SYNTHETIC), MENTHOLAlmark Products Inc6da3aa84-7a01-4041-8792-a4bbf49e6e4e2023-11-10WarningsExact identifier
application number: M017
SMOOTH GATOR 60-second Pain ReliefCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC3b74b542-202f-469e-8025-4372e95e6b012023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f8b8d1-a20b-54b0-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f92e71-fe2e-16f4-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M017
Teeter Renew Muscles Pain RelievingMETHYL SALICYLATE, MENTHOLSTL International INCb90dc5b9-c31d-4770-a291-98d036ae87232023-11-10WarningsExact identifier
application number: M017
SMOOTH GATOR Foot and Leg RubCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC57094238-506b-48c1-8eb9-fe904be80df02023-11-10WarningsExact identifier
application number: M017
SKIN A COOL Hydrocortisone Anti-ItchHYDROCORTISONEAna-Cool, LLCe3ea7406-e494-4038-9b28-8d0a28b4b8342023-11-10WarningsExact identifier
application number: M017
Teeter reNEW MUSCLES Pain RelievingMETHYL SALICYLATE, MENTHOLSTL International INCebc777b0-d141-4a62-9366-d14787eaefe02023-11-10WarningsExact identifier
application number: M017
FEELGOOD LAB Natural Pain CreamMENTHOLThe Feel Good Lab, LLC799d464c-aaf1-429a-877b-2a692397bb492023-11-10WarningsExact identifier
application number: M017
HIGHER CONTROL Male Climax Control LubricatingBENZOCAINEProduct Max Group Inc5f5fd127-34c5-403a-aa95-c9874ae794922023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f93076-1f68-58e6-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f9622e-27c7-6a5d-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
FEEL GOOD LAB Natural Pain CreamMENTHOLTHE FEEL GOOD LAB, LLC774a72b1-b719-4217-846e-7f9921fd1b162023-11-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSNc0df4b8b-2679-4652-9144-a8db916a186b2
2201504Lidozen 4 % / 1 % Medicated PatchPSNc0df4b8b-2679-4652-9144-a8db916a186b2
2201504lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [Lidozen]SBDc0df4b8b-2679-4652-9144-a8db916a186b2
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCDc0df4b8b-2679-4652-9144-a8db916a186b2
1249758lidocaine 4 % / menthol 1 % Medicated PatchSYc0df4b8b-2679-4652-9144-a8db916a186b2
2201504Lidozen (lidocaine 4 % / menthol 1 % ) Medicated PatchSYc0df4b8b-2679-4652-9144-a8db916a186b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-745-05712050745055 PATCH in 1 BOX (71205-745-05) / 1 g in 1 PATCH5 patch2023-01-18NoNoCurrent
71205-745-157120507451515 PATCH in 1 BOX (71205-745-15) / 1 g in 1 PATCH15 patch2023-01-18NoNoCurrent
71205-745-307120507453030 PATCH in 1 BOX (71205-745-30) / 1 g in 1 PATCH30 patch2023-01-18NoNoCurrent