FDA.reportPublic FDA data

Lidocaine Pain Relief Gel Roll-On

Product NDC
84165-003
11-digit product format
841650003
Labeler code
84165
Product ID
84165-003_3c0de968-7f46-7db6-e063-6394a90add34
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
Dosage form
GEL
Route
TOPICAL
Labeler
Guangzhou Zhupuyou E-commerce Co., Ltd
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-28
Substance
MENTHOL; LIDOCAINE
Active strength
.01; .04 g/mL; g/mL
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

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
Lidocaine Pain Relief Gel Roll-On
Listing expiration
2026-12-31

Active Ingredients#

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

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
1804176Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
31639407-0f11-bde2-e063-6294a90af694Available 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
84165-003-01Lidocaine Pain Relief Gel Roll-On73 mL in 1 BOTTLEGEL733
84165-003-01Lidocaine Pain Relief Gel Roll-On1 in 1 BOXGEL13
84165-003-02Lidocaine Pain Relief Gel Roll-On2 in 1 BOXGEL23
84165-003-02Lidocaine Pain Relief Gel Roll-On73 mL in 1 BOTTLEGEL733
84165-003-03Lidocaine Pain Relief Gel Roll-On73 mL in 1 BOTTLEGEL733
84165-003-03Lidocaine Pain Relief Gel Roll-On3 in 1 BOXGEL33
84165-003-04Lidocaine Pain Relief Gel Roll-On4 in 1 BOXGEL43
84165-003-04Lidocaine Pain Relief Gel Roll-On73 mL in 1 BOTTLEGEL733
84165-003-05Lidocaine Pain Relief Gel Roll-On5 in 1 BOXGEL53
84165-003-05Lidocaine Pain Relief Gel Roll-On73 mL in 1 BOTTLEGEL733
84165-003-06Lidocaine Pain Relief Gel Roll-On6 in 1 BOXGEL63
84165-003-06Lidocaine Pain Relief Gel Roll-On73 mL in 1 BOTTLEGEL733
84165-003-07Lidocaine Pain Relief Gel Roll-On7 in 1 BOXGEL73
84165-003-07Lidocaine Pain Relief Gel Roll-On73 mL in 1 BOTTLEGEL733
84165-003-08Lidocaine Pain Relief Gel Roll-On8 in 1 BOXGEL83
84165-003-08Lidocaine Pain Relief Gel Roll-On73 mL in 1 BOTTLEGEL733
84165-003-09Lidocaine Pain Relief Gel Roll-On9 in 1 BOXGEL93
84165-003-09Lidocaine Pain Relief Gel Roll-On73 mL in 1 BOTTLEGEL733
84165-003-10Lidocaine Pain Relief Gel Roll-On10 in 1 BOXGEL103
84165-003-10Lidocaine Pain Relief Gel Roll-On73 mL in 1 BOTTLEGEL733

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84165-003LIDOCAINE PAIN RELIEF GEL ROLL-ON (LIDOCAINE) GEL [GUANGZHOU ZHUPUYOU E-COMMERCE CO., LTD]2Current NDC, 20 package rows20250418_31639407-0f11-bde2-e063-6294a90af694.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 79 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEF PATCHESLIDOCAINEAmerisource Bergen614f1e56-891f-4620-be10-0c075a1dbc3f2025-09-11WarningsExact identifier
application number: M017
Industrial Itch and Pain ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATER & R Lotion, Inc236415fc-f923-4a82-b54a-ecaf666dd2e02025-09-11WarningsExact identifier
application number: M017
Eco Lips Menthol Medicated Lip BalmMENTHOLEco Lips, Inc.fc4c25d6-6109-dfd8-e053-6394a90a4e912025-09-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Encube Ethicals, Inc.d6f5c0df-6262-4704-bb24-430f66bb2ca82025-09-09WarningsExact identifier
application number: M017
Blue-Emu Lidocaine Pain Relief CreamLIDOCAINE CREAM 4%Kingsway Pharmaceuticals dba NFI, LLC592811f2-e21c-6a58-e053-2991aa0a69a92025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation282ed5ef-8c2a-4092-9d99-1a7eee7a39e32025-09-09WarningsExact identifier
application number: M017
LubeLife Climax Control DelayBENZOCAINECC Wellness LLCe1a98e6d-0c24-75b8-e053-2a95a90ad1362025-09-09WarningsExact identifier
application number: M017
Blue-Emu Maximum Pain ReliefTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLCc863351a-951b-4f7c-a9c0-4289d702054a2025-09-09WarningsExact identifier
application number: M017
Tiger Balm Neck and Shoulder RubCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.02a65b25-78b2-4e29-9484-40e2228fb3842025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporatione90df2e5-2ef4-47dd-bd74-be9cea6d9d852025-09-08WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation69d6645e-db3c-4dc0-a9a5-e2bc963e2f282025-09-08WarningsExact identifier
application number: M017
SupreH Arnica Bruise CreamSUPREH ARNICA REMEDY PLUS BRUISE CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3e41fc0e-54c3-2622-e063-6294a90a13c92025-09-07WarningsExact identifier
application number: M017
MentholMENTHOLFlexiGo Inc3607c326-6db0-a2cd-e063-6394a90a9eb62025-09-06WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYOTHERAPY MENTHOL CreamPAIN RELIEF CRYOTHERAPY MENTHOL CREAMShenzhen Sam Technology Co., Ltd.3e08cc87-2385-0838-e063-6394a90abf9b2025-09-05WarningsExact identifier
application number: M017
TIDL CLINICAL CRYOTHERAPY MENTHOL CreamCLINICAL CRYOTHERAPY MENTHOL CREAMShenzhen Sam Technology Co., Ltd.3e090b98-1db7-4174-e063-6394a90aa5392025-09-05WarningsExact identifier
application number: M017
ALCEMISTELIDOCAINE HCLPrice Team Ventures, LLC4383faaa-49cf-47b7-83a6-c2a94b6ff9b52025-09-05WarningsExact identifier
application number: M017
Lansinoh Pain RelievingLIDOCAINE HCLLansinoh Laboratories Incb7cf1fdb-946d-a4e8-e053-2995a90a26a82025-09-05WarningsExact identifier
application number: M017
Sumifun PLANTAR RELIEF ROLL -ON4% LIDOCAINE, 1% MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd3c9ee60b-548a-979f-e063-6394a90a70b02025-09-03WarningsExact identifier
application number: M017
Meijer Capsaicin Heat PatchCAPSAICINMeijer Distribution3c465557-0a4f-fb72-e063-6294a90a1ef22025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC Ventures Corp DBA Cryodermdd95c682-8ddf-43e7-a277-2fca6ec744cc2025-09-02WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1804176lidocaine 4 % / menthol 1 % Topical GelPSN31639407-0f11-bde2-e063-6294a90af6943
1804176lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD31639407-0f11-bde2-e063-6294a90af6943
1804176lidocaine 4 % / menthol 1 % Topical GelSY31639407-0f11-bde2-e063-6294a90af6943

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84165-003-01841650003011 BOTTLE in 1 BOX (84165-003-01) / 73 mL in 1 BOTTLE1 bottle2025-03-28NoNoCurrent
84165-003-02841650003022 BOTTLE in 1 BOX (84165-003-02) / 73 mL in 1 BOTTLE2 bottle2025-03-28NoNoCurrent
84165-003-03841650003033 BOTTLE in 1 BOX (84165-003-03) / 73 mL in 1 BOTTLE3 bottle2025-03-28NoNoCurrent
84165-003-04841650003044 BOTTLE in 1 BOX (84165-003-04) / 73 mL in 1 BOTTLE4 bottle2025-03-28NoNoCurrent
84165-003-05841650003055 BOTTLE in 1 BOX (84165-003-05) / 73 mL in 1 BOTTLE5 bottle2025-03-28NoNoCurrent
84165-003-06841650003066 BOTTLE in 1 BOX (84165-003-06) / 73 mL in 1 BOTTLE6 bottle2025-03-28NoNoCurrent
84165-003-07841650003077 BOTTLE in 1 BOX (84165-003-07) / 73 mL in 1 BOTTLE7 bottle2025-03-28NoNoCurrent
84165-003-08841650003088 BOTTLE in 1 BOX (84165-003-08) / 73 mL in 1 BOTTLE8 bottle2025-03-28NoNoCurrent
84165-003-09841650003099 BOTTLE in 1 BOX (84165-003-09) / 73 mL in 1 BOTTLE9 bottle2025-03-28NoNoCurrent
84165-003-108416500031010 BOTTLE in 1 BOX (84165-003-10) / 73 mL in 1 BOTTLE10 bottle2025-03-28NoNoCurrent