FDA.reportPublic FDA data

Lidocaine Pain Relief Gel Patch

Product NDC
67777-009
11-digit product format
677770009
Labeler code
67777
Product ID
67777-009_4976f92d-e5db-290c-e063-6294a90afb17
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Pain Relief
Dosage form
PATCH
Route
TOPICAL
Labeler
Dynarex
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-27
Substance
LIDOCAINE
Active strength
4 mg/100mg
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

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine Pain Relief Gel Patch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 mg/100mg

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
67777-009-39Lidocaine Pain Relief Gel Patch40 mg in 1 PATCHPATCH4011
67777-009-39Lidocaine Pain Relief Gel Patch5 in 1 BOXPATCH511
67777-009-40Lidocaine Pain Relief Gel Patch60 in 1 CASEPATCH6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-009-39EA - Each67777-00945d38c91-4367-45c5-9131-4a1e3af4ecfb12023-02-06
67777-009-40EA - Each67777-009ecb8f4a8-79f3-4bc9-b33f-5ccc6e8394eb12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-009LIDOCAINE PAIN RELIEF GEL PATCH (LIDOCAINE PAIN RELIEF) PATCH [DYNAREX]10Current NDC, Legacy NDC, 3 package rows20241222_960e4240-cd09-2560-e053-2a95a90a7bcf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSN960e4240-cd09-2560-e053-2a95a90a7bcf11
1737778lidocaine 0.04 MG/MG Medicated PatchSCD960e4240-cd09-2560-e053-2a95a90a7bcf11
1737778lidocaine 4 % Medicated PatchSY960e4240-cd09-2560-e053-2a95a90a7bcf11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-009-396777700093940 mg in 1 PATCH40 mgHistorical
67777-009-406777700094060 BOX in 1 CASE (67777-009-40) / 5 PATCH in 1 BOX (67777-009-39) / 40 mg in 1 PATCH60 box2019-08-270000-00-00NoNoCurrent