FDA.reportPublic FDA data

Relevea Pain Relief Patch

Product NDC
51028-004
11-digit product format
510280004
Labeler code
51028
Product ID
51028-004_5ba14330-677c-454a-e063-6394a90ac0e7
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine 4%
Dosage form
PATCH
Route
TOPICAL
Labeler
Links Medical Products
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-01
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
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
Relevea Pain Relief Patch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g

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
51028-004-01Relevea Pain Relief Patch15 in 1 BOXPATCH151
51028-004-01Relevea Pain Relief Patch1 g in 1 PATCHPATCH11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSN3ce49b85-e9e3-e33c-e063-6294a90a6dbf1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD3ce49b85-e9e3-e33c-e063-6294a90a6dbf1
1737778lidocaine 4 % Medicated PatchSY3ce49b85-e9e3-e33c-e063-6294a90a6dbf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51028-004-015102800040115 PATCH in 1 BOX (51028-004-01) / 1 g in 1 PATCH15 patch2025-08-01NoNoCurrent
51028-004-025102800040215 PATCH in 1 BOX (51028-004-02) / 1 g in 1 PATCH15 patch2025-08-01NoNoCurrent
51028-004-03510280004031 g in 1 POUCH (51028-004-03) 1 g2026-09-30NoNoCurrent
51028-004-155102800041515 POUCH in 1 BOX (51028-004-15) / 1 g in 1 POUCH15 pouch2026-09-30NoNoCurrent