FDA.reportPublic FDA data

Lidozen Patch

Product NDC
71574-905
11-digit product format
715740905
Labeler code
71574
Product ID
71574-905_fa3635ec-4a51-4f90-bce0-6c98e7b450f5
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE, MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
Village Pharma LLC
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
d0ec7d25-ad58-46f2-b3b3-f13b4648b0b6Available 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
71574-905-05Lidozen Patch1 g in 1 PATCHPATCH13
71574-905-05Lidozen Patch5 in 1 POUCHPATCH53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71574-905-05EA - Each71574-905b8a8a20a-b5ce-4b1a-9b27-77ca28be07d912023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71574-905LIDOZEN PATCH (LIDOCAINE, MENTHOL) PATCH [VILLAGE PHARMA LLC]2Current NDC, Legacy NDC, 2 package rows20231201_d0ec7d25-ad58-46f2-b3b3-f13b4648b0b6.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 60 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sohm Pain AwayMENTHOL, CAMPHORSOHM, Inc86632acf-80ae-48d7-a0bb-7ec980326bae2025-11-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Pain ReliefLIDOCAINE 4%Veridian Healthcare6f2332c0-e078-40a8-9564-f47d21bc491b2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC44779065-5f57-8f01-e063-6394a90a3f8e2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC44786cb6-176e-cc6e-e063-6394a90a54ad2025-11-25WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFVALU MERCHANDISERS, CO3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff2025-11-24WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDERVALU MERCHANDISERS, CO89a5c4bb-442f-d3f0-e053-2a95a90a51bd2025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d11ab8e-d3ea-c7ef-e063-6294a90ae0a32025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d113dec-8832-d984-e063-6394a90ae7b32025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d12f03f-dd8b-0be5-e063-6294a90a43db2025-11-24WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d129641-eaea-c3ee-e063-6394a90aa58f2025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d1059cc-1b0b-4e7b-e063-6294a90a56ea2025-11-24WarningsExact identifier
application number: M017
GuruNanda Pain ReliefMENTHOL AND CAMPHORGURUNANDA, LLC3ca78342-cc6d-5f6b-e063-6294a90a3f1c2025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d118256-90ee-28ef-e063-6394a90a21e82025-11-24WarningsExact identifier
application number: M017
health beyondHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af2025-11-23WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 3 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4429fea8-46f8-8f7f-e063-6394a90a34b42025-11-22WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 2 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442a926b-d7c1-4e35-e063-6394a90ad9482025-11-22WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 1 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442aae32-4ac6-5dd6-e063-6294a90aad022025-11-22WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine Patches 1-3 Step21MG NICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442ae0fa-a1ed-7901-e063-6294a90ab7172025-11-22WarningsExact identifier
application number: M017
IceQuake Lidocaine AnalgesicLIDOCAINE HYDROCHLORIDEDextrum Laboratories, Inc441daa6f-f273-ac09-e063-6394a90a252c2025-11-21WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSNd0ec7d25-ad58-46f2-b3b3-f13b4648b0b63
2201504Lidozen 4 % / 1 % Medicated PatchPSNd0ec7d25-ad58-46f2-b3b3-f13b4648b0b63
2201504lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [Lidozen]SBDd0ec7d25-ad58-46f2-b3b3-f13b4648b0b63
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCDd0ec7d25-ad58-46f2-b3b3-f13b4648b0b63
1249758lidocaine 4 % / menthol 1 % Medicated PatchSYd0ec7d25-ad58-46f2-b3b3-f13b4648b0b63
2201504Lidozen (lidocaine 4 % / menthol 1 % ) Medicated PatchSYd0ec7d25-ad58-46f2-b3b3-f13b4648b0b63
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 startMarketing endSampleExclude flagStatus
71574-905-05715740905055 PATCH in 1 POUCH (71574-905-05) / 1 g in 1 PATCH5 patch2022-09-010000-00-00NoNoCurrent