FDA.reportPublic FDA data

Lidocaine Pain Relief

Product NDC
0121-0970
11-digit product format
001210970
Labeler code
0121
Product ID
0121-0970_096b4296-4123-4481-af04-4caa75e381a0
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Pain Relief
Dosage form
PATCH
Route
TOPICAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-03
Substance
LIDOCAINE
Active strength
560 mg/1
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE560 mg/1

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
0121-0970-01Lidocaine Pain Relief1 in 1 POUCHPATCH18
0121-0970-05Lidocaine Pain Relief12 in 1 CASEPATCH128
0121-0970-05Lidocaine Pain Relief5 in 1 CARTONPATCH58
0121-0970-30Lidocaine Pain Relief30 in 1 CARTONPATCH308
0121-0970-30Lidocaine Pain Relief6 in 1 CASEPATCH68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0970-01EA - Each0121-09705d9bd700-4e66-40a2-be05-aebb7520310312023-04-07
0121-0970-05EA - Each0121-09707a5d0182-4fb5-46d2-8d6b-f136e6afd68712023-04-07
0121-0970-30EA - Each0121-0970b4b6ce30-5baf-4336-945e-9b57c01a93a712024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0970LIDOCAINE PAIN RELIEF PATCH [PAI HOLDINGS, LLC DBA PAI PHARMA]6Current NDC, 5 package rows20250110_963978de-8295-47ee-9b06-64c3521aa994.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSN963978de-8295-47ee-9b06-64c3521aa9948
1737778lidocaine 0.04 MG/MG Medicated PatchSCD963978de-8295-47ee-9b06-64c3521aa9948
1737778lidocaine 4 % Medicated PatchSY963978de-8295-47ee-9b06-64c3521aa9948

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-0970-01001210970011 in 1 POUCHHistorical
0121-0970-050012109700512 in 1 CASEHistorical
0121-0970-30001210970306 CARTON in 1 CASE (0121-0970-30) / 30 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0121-0970-01) 6 carton2024-07-29NoNoHistorical