FDA.reportPublic FDA data

LidocainePain pain reliving gel-patch

Product NDC
84291-005
11-digit product format
842910005
Labeler code
84291
Product ID
84291-005_461e9656-e156-8597-e063-6394a90a2dcd
Type
HUMAN OTC DRUG
Nonproprietary name
pain reliving gel-patch
Dosage form
PATCH
Route
TOPICAL
Labeler
Shenzhen Yuetai Electronic Commerce Co., Ltd
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-11
Substance
LIDOCAINE
Active strength
4 U/100U
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
LidocainePain pain reliving gel-patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 U/100U

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737778Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
461ebbdd-0f26-a333-e063-6394a90a7a3eAvailable 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
84291-005-01LidocainePain pain reliving gel-patch34 U in 1 BOXPATCH342
84291-005-02LidocainePain pain reliving gel-patch30 U in 1 BOXPATCH302
84291-005-03LidocainePain pain reliving gel-patch25 U in 1 BOXPATCH252
84291-005-04LidocainePain pain reliving gel-patch26 U in 1 BOXPATCH262
84291-005-05LidocainePain pain reliving gel-patch20 U in 1 BOXPATCH202
84291-005-06LidocainePain pain reliving gel-patch15 U in 1 BOXPATCH152
84291-005-07LidocainePain pain reliving gel-patch10 U in 1 BOXPATCH102

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 142 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tact Cool JellyDIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOLSato Pharmaceutical Co., Ltd.f34872c9-91b9-49db-8e41-5b54a069284a2023-12-01WarningsExact identifier
application number: M017
SatohapMETHYL SALICYLATE, DL-CAMPHOR, L-MENTHOLSato Pharmaceutical Co., Ltd.348fde05-2797-4410-a1b2-99e64187c4fe2023-12-01WarningsExact identifier
application number: M017
Menthozen HydrogelMENTHOL, CAPSAICINProficient Rx LP85a7809e-c43f-4138-a85b-44e1b586def52023-12-01WarningsExact identifier
application number: M017
Menthozen CreamMETHYL SALICYLATE, MENTHOL, CAPSAICINProficient Rx LP66681906-c5f5-4c57-bb43-9c83cccc00622023-12-01WarningsExact identifier
application number: M017
Lidozen PatchLIDOCAINE, MENTHOLProficient Rx LPc0df4b8b-2679-4652-9144-a8db916a186b2023-12-01WarningsExact identifier
application number: M017
Lidozen GelLIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LP7c300dec-cefd-4b79-a948-a917b7708a042023-12-01WarningsExact identifier
application number: M017
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINProficient Rx LP2adf3c4d-636f-4e02-b501-946b4df5f5d62023-12-01WarningsExact identifier
application number: M017
LidozenLIDOCAINE, MENTHOLProficient Rx LP488d665c-a4fe-4a69-bab3-34b2347f4b052023-12-01WarningsExact identifier
application number: M017
Thera Plus Max Strength Lidocaine Pain Relief LiquidLIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.0a228b06-0e1c-6c75-e063-6294a90a9a0e2023-11-30WarningsExact identifier
application number: M017
Thera Plus Cool and Heat Pain Relieving Gel MentholMENTHOLFourstar Group USA, Inc.0a225714-ccb1-4676-e063-6294a90aeeb22023-11-30WarningsExact identifier
application number: M017
Bloop Itch Soothing TopicalHYDROCORTISONEThree Nations Corp0b64677e-d4bf-0929-e063-6294a90af1372023-11-30WarningsExact identifier
application number: M017
Ice QuakeMENTHOLSouthern Sales & Service, Inc.7a05832f-49ac-4013-b240-4405501e45cd2023-11-29WarningsExact identifier
application number: M017
ICE MUSCLE RUB Leon M.CMENTHOLSouthern Sales & Service, Inc.4efaf347-7406-4690-8005-e7cf2e3d42222023-11-29WarningsExact identifier
application number: M017
IceQuake Analgestic WhiteMETHYL SALICYLATE, MENTHOLSouthern Sales & Service, Inc.54e5dcd5-9987-488d-a758-d0e76d1551822023-11-29WarningsExact identifier
application number: M017
Icequake Coldn Hot medicated patchMENTHOLSouthern Sales & Service, Inc.89202c52-9eb7-4e5a-a709-4a66ab0d3a722023-11-29WarningsExact identifier
application number: M017
IceQuake Lidocaine AnalgesicLIDOCAINE HYDROCHLORIDESouthern Sales & Service, Inc.9089cb78-e9f8-4437-a767-df809a114c4b2023-11-29WarningsExact identifier
application number: M017
Ice Quake Muscle Rub BlueMENTHOLSouthern Sales & Service, Inc.5180f6a3-58f1-4c50-a33b-7d85a3c1b99b2023-11-29WarningsExact identifier
application number: M017
Discount Drug Mart Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEDiscount Drug Mart8579df23-ac07-9df8-e053-2991aa0a8bbb2023-11-29WarningsExact identifier
application number: M017
SatohapMETHYL SALICYLATE, DL-CAMPHOR, L-MENTHOLSato Pharmaceutical Co., Ltd.3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf2023-11-28WarningsExact identifier
application number: M017
Poli-AHYDROCORTISONE ACETATESato Pharmaceutical Co., Ltd.e27a3840-d9de-4bd0-ad75-8a151bd12b832023-11-28WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSN461ebbdd-0f26-a333-e063-6394a90a7a3e2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD461ebbdd-0f26-a333-e063-6394a90a7a3e2
1737778lidocaine 4 % Medicated PatchSY461ebbdd-0f26-a333-e063-6394a90a7a3e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84291-005-018429100050134 U in 1 BOX (84291-005-01) 34 u2025-12-11NoNoCurrent
84291-005-028429100050230 U in 1 BOX (84291-005-02) 30 u2025-12-11NoNoCurrent
84291-005-038429100050325 U in 1 BOX (84291-005-03) 25 u2025-12-11NoNoCurrent
84291-005-048429100050426 U in 1 BOX (84291-005-04) 26 u2025-12-11NoNoCurrent
84291-005-058429100050520 U in 1 BOX (84291-005-05) 20 u2025-12-11NoNoCurrent
84291-005-068429100050615 U in 1 BOX (84291-005-06) 15 u2025-12-11NoNoCurrent
84291-005-078429100050710 U in 1 BOX (84291-005-07) 10 u2025-12-11NoNoCurrent