FDA.reportPublic FDA data

Lidocaine Pain Relieve Gel-Patch

Product NDC
69561-005
11-digit product format
695610005
Labeler code
69561
Product ID
69561-005_4a37ed9c-5f8b-ad8b-e063-6394a90ac527
Type
HUMAN OTC DRUG
Nonproprietary name
Pain Relieve Gel-Patch
Dosage form
PATCH
Route
TOPICAL
Labeler
Henan Kangdi Medical Devices Co., Ltd
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-27
Substance
LIDOCAINE
Active strength
4 g/100g
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
Lidocaine Pain Relieve Gel-Patch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100g

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
1e31b950-e990-e255-e063-6394a90a7d23Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69561-005-012026-01-29C16284748780-149896155-ac76-586f-e063-e6dba90add9069561-005-01
69561-005-022026-01-29C16284748780-149896155-ac76-586f-e063-e6dba90add9069561-005-01
69561-005-032026-01-29C16284748780-149896155-ac76-586f-e063-e6dba90add9069561-005-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69561-005-01Lidocaine Pain Relieve Gel-Patch10 in 1 BOXPATCH103
69561-005-01Lidocaine Pain Relieve Gel-Patch12 g in 1 PATCHPATCH123
69561-005-02Lidocaine Pain Relieve Gel-Patch12 g in 1 PATCHPATCH123
69561-005-02Lidocaine Pain Relieve Gel-Patch18 in 1 BOXPATCH183
69561-005-03Lidocaine Pain Relieve Gel-Patch30 in 1 BOXPATCH303
69561-005-03Lidocaine Pain Relieve Gel-Patch12 g in 1 PATCHPATCH123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69561-005LIDOCAINE PAIN RELIEVE GEL-PATCH (PAIN RELIEVE GEL-PATCH) PATCH [HENAN KANGDI MEDICAL DEVICES CO., LTD]2Current NDC, 6 package rows20240801_1e31b950-e990-e255-e063-6394a90a7d23.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 128 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AOSI HEALTHCARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a28b920c-0bb8-4b5a-addd-26ea164e036e2024-09-25WarningsExact identifier
application number: M017
anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger Company067e718a-ec0b-4895-8f9f-82d64ab4c7b42024-09-24WarningsExact identifier
application number: M017
topcare anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATETopco Associates LLCe0fb332a-2903-41ef-b35b-7cd3a74cff992024-09-24WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI83cd9f60-a4c4-4dea-97a7-cd96aade9e882024-09-24WarningsExact identifier
application number: M017
good sense itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEL. Perrigo Company162fe0a3-3995-4e6f-94ed-f839b2b0c80e2024-09-24WarningsExact identifier
application number: M017
Caring Mill Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare22ca137a-576c-a13c-e063-6394a90ae7fc2024-09-23WarningsExact identifier
application number: M017
Signature Care Anti ItchHYDROCORTISONESafewayed0eb068-3ce6-423d-a7f8-c3456b7f60402024-09-23WarningsExact identifier
application number: M017
members mark hydrocortisoneHYDROCORTISONESam's West Inc218f0dcd-fa67-4935-8019-ecbbd53ed2f72024-09-23WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEMeijer, Inc.a07496e0-6fc2-4190-8a01-f513134ffb922024-09-23WarningsExact identifier
application number: M017
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLWhitestone Products LLC2301fed7-0fa9-450d-8b1b-006f53235be02024-09-21WarningsExact identifier
application number: M017
Tibetree Cheezheng Joint Analgesic PatchCAMPHORTibet Cheezheng Tibetan Medicine Co. Ltd65a8a63f-1864-473e-be72-7840a6a5dee72024-09-20WarningsExact identifier
application number: M017
Cold Ice Analgesic GelMENTHOLDabur India Limited22915b2f-5f76-3e38-e063-6394a90a07b42024-09-20WarningsExact identifier
application number: M017
Exchange Select HydrocortisoneHYDROCORTISONEArmy & Air Force Exchange Service1b709db3-7dc1-4756-a8a0-dddda875dc572024-09-19WarningsExact identifier
application number: M017
Theraworx PM Nighttime Maximum Strength Pain ReliefLIDOCAINE HYDROCHLORIDEAVADIM HOLDINGS, INC.bc8cb476-9a47-47b3-ad78-a6ecec9ee66f2024-09-19WarningsExact identifier
application number: M017
LidocaineLIDOCAINEStratus Pharmaceuticals Ince1a8d4a7-01f7-4bab-8d09-875c461b3b612024-09-19WarningsExact identifier
application number: M017
Camphor SpiritCAMPHOR 10%Strategic Sourcing Services, LLC2216d799-7f6f-cab7-e063-6294a90a8d6c2024-09-14WarningsExact identifier
application number: M017
Meijer Analgesic Lidocaine Topical AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Incf5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa2024-09-12WarningsExact identifier
application number: M017
leader anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECardinal Health 110, LLC. dba Leadere1aab35b-80d9-4515-afb7-8c662bc5d0282024-09-11WarningsExact identifier
application number: M017
LactiGoMENTHOLLactiGo, Inc.849c3601-2bc8-0991-e053-2a91aa0a5e7f2024-09-03WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief Gel Platinum - ArthritisMENTHOL 8%Telebrands Corpc22cf1a5-0d5d-5ea5-e053-2995a90a333b2024-09-02WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSN1e31b950-e990-e255-e063-6394a90a7d233
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1e31b950-e990-e255-e063-6394a90a7d233
1737778lidocaine 4 % Medicated PatchSY1e31b950-e990-e255-e063-6394a90a7d233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69561-005-016956100050110 PATCH in 1 BOX (69561-005-01) / 12 g in 1 PATCH10 patch2024-07-27NoNoCurrent
69561-005-026956100050218 PATCH in 1 BOX (69561-005-02) / 12 g in 1 PATCH18 patch2024-07-27NoNoCurrent
69561-005-036956100050330 PATCH in 1 BOX (69561-005-03) / 12 g in 1 PATCH30 patch2024-07-27NoNoCurrent