FDA.reportPublic FDA data

Point Relief LidoSpot with Menthol

Product NDC
51452-912
11-digit product format
514520912
Labeler code
51452
Product ID
51452-912_47061346-aa5f-1a85-e063-6294a90afd0a
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Fabrication Enterprises
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
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51452-912-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51452-912-05IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51452-912-05IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51452-912-05IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51452-912-05IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51452-912-05IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51452-912-05UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51452-912-05UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51452-912-05UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Point Relief LidoSpot with Menthol
Listing expiration
2026-12-31

Active Ingredients#

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

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f0c69693-bfea-4006-9620-63b222d25d38Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51452-912-052025-12-28C16284748780-12cef2736-b01e-d83d-e063-dadaa90ab31fPoint Relief LidoSpot with Menthol
51452-912-052025-01-30C16284748780-12cef2736-b01e-d83d-e063-dadaa90ab31fPoint Relief LidoSpot with Menthol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51452-912-05Point Relief LidoSpot with Menthol8 g in 1 PATCHPATCH83
51452-912-05Point Relief LidoSpot with Menthol5 in 1 POUCHPATCH53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51452-912POINT RELIEF LIDOSPOT WITH MENTHOL (LIDOCAINE, MENTHOL) PATCH [FABRICATION ENTERPRISES]2Current NDC, Legacy NDC, 2 package rows20230112_f0c69693-bfea-4006-9620-63b222d25d38.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 143 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesb505769e-9c46-3cf3-e053-2a95a90a4df92023-11-17WarningsExact identifier
application number: M017
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesd6523993-d781-cdbc-e053-2a95a90af1912023-11-17WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.4d91baf3-9655-4786-93b8-aa0d93fe0bf92023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPMENTHOLKOBAYASHI Healthcare International, Inc.7ef03298-6623-4cf4-b21f-74b2ffc11c6e2023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.436e8578-b609-4b45-8f84-0d111140fda62023-11-16WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOLKOBAYASHI Healthcare International, Inc.08dcfa78-7332-4f19-90d7-fdd7d446848a2023-11-16WarningsExact identifier
application number: M017
Totally Fun After SunLIDOCAINE HCLMJ Products Association, LLC965a2a29-914c-4ad0-b25f-5df3c30da3932023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f2023-11-15WarningsExact identifier
application number: M017
ZIMS MAX FREEZE PRO FORMULAMENTHOL, UNSPECIFIED FORMKOBAYASHI Healthcare International, Inc.b44beac3-1d20-434f-9a79-4fab1ac687912023-11-15WarningsExact identifier
application number: M017
Universal Ice Cold AnalgesicMENTHOLUniversal Distribution Center LLC79ad55eb-b59d-4bb8-88e3-3b51e10a7f282023-11-15WarningsExact identifier
application number: M017
PURE EASE Joint Muscle lnstant Pain ReliefCAPSAICIN, MENTHOLSERENU, INC.42bf129c-5c84-4331-b6d0-78e3be71a9852023-11-13WarningsExact identifier
application number: M017
PURE EASE Neur Cream Instant Deep Pain ReliefCAPSAICIN, MENTHOLSERENU, INC.e46a4636-6405-440a-a05a-862c354bab542023-11-13WarningsExact identifier
application number: M017
Cryomax CoolingMENTHOLLIFE WEAR TECHNOLOGIES0a0ae5ba-9fac-45f6-e063-6294a90ad5552023-11-13WarningsExact identifier
application number: M017
LBri Super Aloe Stop The PainMETHYL SALICYLATE, MENTHOL, CAPSAICINL'Bris, Pure 'N Natural8fb2010c-c34b-4552-858d-a0188ad313ad2023-11-11WarningsExact identifier
application number: M017
TOTAL RELIEFHYDROCORTISONEDR. MARDER SKINCARE, LLC2c05459c-5a2c-45ab-b534-87f966b416812023-11-11WarningsExact identifier
application number: M017
Human Science Muscle Pain ReliefMETHYL SALICYLATE, MENTHOLHuman Science, LLC4bccc017-264b-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M017
LidozenLIDOCAINE HYDROCHLORIDE, MENTHOLVillage Pharma, LLC55108ffd-d6a8-41de-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M017
Debbies Down and Dirty Deep Tissue Joint and MuscleMENTHOLDD&D Manufacturing Co., Ltd531fe834-53e3-305f-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M017
TerraFreeze Pain ReliefMENTHOL,METHYL SALICYLATE,HISTAMINE DIHYDROCHLORIDEBeyond Derma, LLC81dc70b3-7e93-4f9a-ae3a-b50bbfd1a6772023-11-11WarningsExact identifier
application number: M017
GOLD ICE Pain ReliefMENTHOLEden's Answers, Inc.a1356c39-42b9-4bd8-a873-bcd40717058b2023-11-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSNf0c69693-bfea-4006-9620-63b222d25d383
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCDf0c69693-bfea-4006-9620-63b222d25d383
1249758lidocaine 4 % / menthol 1 % Medicated PatchSYf0c69693-bfea-4006-9620-63b222d25d383

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51452-912-05514520912055 PATCH in 1 POUCH (51452-912-05) / 8 g in 1 PATCH5 patch2018-07-010000-00-00NoNoCurrent