FDA.reportPublic FDA data

PAIN RELIEF Gel-Patch

Product NDC
84165-104
Requested package NDC
84165-104-43
11-digit product format
841650104
Labeler code
84165
Product ID
84165-104_47db7f81-d850-5672-e063-6294a90aae8a
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Guangzhou Zhupuyou E-commerce Co., Ltd
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-24
Substance
MENTHOL; LIDOCAINE
Active strength
.01; .04 g/g; g/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
PAIN RELIEF Gel-Patch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.01 g/g
LIDOCAINE.04 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
98PI200987Internal 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
22d9ce20-1cb6-c5bd-e063-6394a90a9ecaAvailable on FDA.report

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
84165-104-01PAIN RELIEF Gel-Patch12 g in 1 BAGPATCH122
84165-104-05PAIN RELIEF Gel-Patch5 in 1 BOXPATCH52
84165-104-06PAIN RELIEF Gel-Patch6 in 1 BOXPATCH62
84165-104-07PAIN RELIEF Gel-Patch7 in 1 BOXPATCH72
84165-104-08PAIN RELIEF Gel-Patch8 in 1 BOXPATCH82
84165-104-09PAIN RELIEF Gel-Patch9 in 1 BOXPATCH92
84165-104-10PAIN RELIEF Gel-Patch10 in 1 BOXPATCH102
84165-104-11PAIN RELIEF Gel-Patch11 in 1 BOXPATCH112
84165-104-12PAIN RELIEF Gel-Patch12 in 1 BOXPATCH122
84165-104-13PAIN RELIEF Gel-Patch13 in 1 BOXPATCH132
84165-104-14PAIN RELIEF Gel-Patch14 in 1 BOXPATCH142
84165-104-15PAIN RELIEF Gel-Patch15 in 1 BOXPATCH152
84165-104-16PAIN RELIEF Gel-Patch16 in 1 BOXPATCH162
84165-104-17PAIN RELIEF Gel-Patch17 in 1 BOXPATCH172
84165-104-18PAIN RELIEF Gel-Patch18 in 1 BOXPATCH182
84165-104-19PAIN RELIEF Gel-Patch19 in 1 BOXPATCH192
84165-104-20PAIN RELIEF Gel-Patch20 in 1 BOXPATCH202
84165-104-21PAIN RELIEF Gel-Patch21 in 1 BOXPATCH212
84165-104-22PAIN RELIEF Gel-Patch22 in 1 BOXPATCH222
84165-104-23PAIN RELIEF Gel-Patch23 in 1 BOXPATCH232
84165-104-24PAIN RELIEF Gel-Patch24 in 1 BOXPATCH242
84165-104-25PAIN RELIEF Gel-Patch25 in 1 BOXPATCH252
84165-104-26PAIN RELIEF Gel-Patch26 in 1 BOXPATCH262
84165-104-27PAIN RELIEF Gel-Patch27 in 1 BOXPATCH272
84165-104-28PAIN RELIEF Gel-Patch28 in 1 BOXPATCH282
84165-104-29PAIN RELIEF Gel-Patch29 in 1 BOXPATCH292
84165-104-30PAIN RELIEF Gel-Patch30 in 1 BOXPATCH302
84165-104-31PAIN RELIEF Gel-Patch31 in 1 BOXPATCH312
84165-104-32PAIN RELIEF Gel-Patch32 in 1 BOXPATCH322
84165-104-33PAIN RELIEF Gel-Patch33 in 1 BOXPATCH332
84165-104-34PAIN RELIEF Gel-Patch34 in 1 BOXPATCH342
84165-104-35PAIN RELIEF Gel-Patch35 in 1 BOXPATCH352
84165-104-36PAIN RELIEF Gel-Patch36 in 1 BOXPATCH362
84165-104-37PAIN RELIEF Gel-Patch37 in 1 BOXPATCH372
84165-104-38PAIN RELIEF Gel-Patch38 in 1 BOXPATCH382
84165-104-39PAIN RELIEF Gel-Patch39 in 1 BOXPATCH392
84165-104-40PAIN RELIEF Gel-Patch40 in 1 BOXPATCH402
84165-104-41PAIN RELIEF Gel-Patch41 in 1 BOXPATCH412
84165-104-42PAIN RELIEF Gel-Patch42 in 1 BOXPATCH422
84165-104-43PAIN RELIEF Gel-Patch43 in 1 BOXPATCH432
84165-104-44PAIN RELIEF Gel-Patch44 in 1 BOXPATCH442
84165-104-45PAIN RELIEF Gel-Patch45 in 1 BOXPATCH452
84165-104-46PAIN RELIEF Gel-Patch46 in 1 BOXPATCH462
84165-104-47PAIN RELIEF Gel-Patch47 in 1 BOXPATCH472
84165-104-48PAIN RELIEF Gel-Patch48 in 1 BOXPATCH482
84165-104-49PAIN RELIEF Gel-Patch49 in 1 BOXPATCH492
84165-104-50PAIN RELIEF Gel-Patch50 in 1 BOXPATCH502
84165-104-51PAIN RELIEF Gel-Patch51 in 1 BOXPATCH512
84165-104-52PAIN RELIEF Gel-Patch52 in 1 BOXPATCH522
84165-104-53PAIN RELIEF Gel-Patch53 in 1 BOXPATCH532
84165-104-54PAIN RELIEF Gel-Patch54 in 1 BOXPATCH542
84165-104-55PAIN RELIEF Gel-Patch55 in 1 BOXPATCH552
84165-104-56PAIN RELIEF Gel-Patch56 in 1 BOXPATCH562

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84165-104PAIN RELIEF GEL-PATCH (LIDOCAINE, MENTHOL) PATCH [GUANGZHOU ZHUPUYOU E-COMMERCE CO., LTD]1Current NDC, 53 package rows20240926_22d9ce20-1cb6-c5bd-e063-6394a90a9eca.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 1 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JenGufun LIDOCAINE KNEE PatchLIDOCAINE KNEE PATCHHenan Kangdi Medical Devices Co., Ltd.5b1d8508-b993-7a8d-e063-6294a90ae3062026-09-10WarningsExact identifier
application number: M017
Wart Corn RemoverSALICYLIC ACIDHONG KONG FOREVER YOUNG TRADING CO., LIMITED5b0cd6e0-f220-4ebd-e063-6294a90ade672026-09-09WarningsExact identifier
application number: M017
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
application number: M017
Burn GelLIDOCAINE HCITrifecta Pharmaceuticals USA LLCe9d3e9be-1036-fad0-e053-2a95a90a6efe2026-09-09WarningsExact identifier
application number: M017
4% Lidocaine Pain Relief PatchLIDOCAINE 4%Guangxi Keyun E-commerce Co., Ltd.5b197cd8-542f-38b4-e063-6294a90ad7d32026-09-09WarningsExact identifier
application number: M017
Pain Relieving Lidocaine PatchLIDOCAINEYYBA CORPaf8c84fd-224c-72b3-e053-2a95a90a95682026-09-07WarningsExact identifier
application number: M017
American Safety First AidLIDOCAINE HCLOrazen Incea2f776b-dfd0-6ce4-e053-2995a90af0092026-09-07WarningsExact identifier
application number: M017
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
application number: M017
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
application number: M017
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
application number: M017
NeuroNesic Pain Relieving CreamCAPSAICINBlaine Labs Inc.7107c13d-bf59-4c0a-84fe-725a9fca26912026-09-04WarningsExact identifier
application number: M017
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsExact identifier
application number: M017
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
application number: M017
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
application number: M017
Komxsum LIDOCAINE CreamLIDOCAINE 4% CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9feae0-9be4-e736-e063-6294a90abe552026-09-03WarningsExact identifier
application number: M017
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
application number: M017
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
application number: M017
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsExact identifier
application number: M017
Ramedica Herbal Wonder BalmCAMPHOR, MENTHOLRamedicare Sdn. Bhd.cfb2ea0e-a1f6-4fdf-b866-346bbe78788f2026-09-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN22d9ce20-1cb6-c5bd-e063-6394a90a9eca2
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD22d9ce20-1cb6-c5bd-e063-6394a90a9eca2
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY22d9ce20-1cb6-c5bd-e063-6394a90a9eca2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84165-104-438416501044343 BAG in 1 BOX (84165-104-43) / 12 g in 1 BAG (84165-104-01) 43 bag2024-09-24NoNoCurrent