LABOFLEX Lidocaine Pain Relieving Patch

Product NDC
83655-109
11-digit product format
836550109
Labeler code
83655
Product ID
83655-109_31995f54-889e-c027-e063-6294a90a3da3
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine 4%
Dosage form
PATCH
Route
TOPICAL
Labeler
Laboflex, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-10
Substance
LIDOCAINE
Active strength
40 mg/g
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
LABOFLEX Lidocaine Pain Relieving Patch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g

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
83655-109-15LABOFLEX Lidocaine Pain Relieving Patch5 in 1 BOXPATCH51
83655-109-15LABOFLEX Lidocaine Pain Relieving Patch1 g in 1 POUCHPATCH11
83655-109-25LABOFLEX Lidocaine Pain Relieving Patch1 g in 1 POUCHPATCH11
83655-109-25LABOFLEX Lidocaine Pain Relieving Patch5 in 1 BOXPATCH51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83655-109LABOFLEX LIDOCAINE PAIN RELIEVING PATCH (LIDOCAINE 4%) PATCH [LABOFLEX, INC.]1Current NDC, 2 package rows20250402_31995f31-c272-afdb-e063-6294a90af3f9.zip
83655-109LABOFLEX LIDOCAINE PAIN RELIEVING PATCH (LIDOCAINE 4%) PATCH [LABOFLEX, INC.]1Current NDC, 2 package rows20250112_2a3c23ed-e850-1390-e063-6294a90a637f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSN2a3c23ed-e850-1390-e063-6294a90a637f1
1737778lidocaine 4 % Medicated PatchPSN31995f31-c272-afdb-e063-6294a90af3f91
1737778lidocaine 0.04 MG/MG Medicated PatchSCD2a3c23ed-e850-1390-e063-6294a90a637f1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD31995f31-c272-afdb-e063-6294a90af3f91
1737778lidocaine 4 % Medicated PatchSY2a3c23ed-e850-1390-e063-6294a90a637f1
1737778lidocaine 4 % Medicated PatchSY31995f31-c272-afdb-e063-6294a90af3f91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83655-109-15836550109155 POUCH in 1 BOX (83655-109-15) / 1 g in 1 POUCH5 pouch2025-01-10NoNoCurrent
83655-109-25836550109251 g in 1 POUCH1 gHistorical