FDA.reportPublic FDA data

ThermaPatch (TM) Lidocaine Pain Relief Patch

Product NDC
83559-006
11-digit product format
835590006
Labeler code
83559
Product ID
83559-006_26769590-cd51-1b01-e063-6394a90a445c
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Pain Relief Patch
Dosage form
PATCH
Route
TOPICAL
Labeler
Henan Enokon Medical Instrument Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-09
Substance
LIDOCAINE
Active strength
4 g/1001
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

Additional Listing Data#

Finished product
Yes
Brand name base
ThermaPatch (TM) Lidocaine Pain Relief Patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/1001

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1737778

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
83559-006-01ThermaPatch (TM) Lidocaine Pain Relief Patch6 in 1 BOXPATCH61
83559-006-01ThermaPatch (TM) Lidocaine Pain Relief Patch1 in 1 PATCHPATCH11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83559-006THERMAPATCH (TM) LIDOCAINE PAIN RELIEF PATCH (LIDOCAINE PAIN RELIEF PATCH) PATCH [HENAN ENOKON MEDICAL INSTRUMENT CO., LTD.]1Current NDC, 2 package rows20241110_26769590-cd50-1b01-e063-6394a90a445c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSN26769590-cd50-1b01-e063-6394a90a445c1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD26769590-cd50-1b01-e063-6394a90a445c1
1737778lidocaine 4 % Medicated PatchSY26769590-cd50-1b01-e063-6394a90a445c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83559-006-01835590006016 PATCH in 1 BOX (83559-006-01) / 1 PATCH in 1 PATCH6 patch2024-11-09NoNoHistorical