FDA.reportPublic FDA data

LIDODERM

Product NDC
63481-687
11-digit product format
634810687
Labeler code
63481
Product ID
63481-687_2088f989-5126-4349-8267-398a42918217
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine
Dosage form
PATCH
Route
CUTANEOUS
Labeler
Endo Pharmaceuticals Inc.
Application
NDA020612
Marketing category
NDA
Marketing start
1999-03-20
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
50 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63481-687-06EA - Each63481-68749aa1173-6183-4dec-a6de-870352e07b6912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
LIDOCAINEACTIVE MOIETY98PI200987LIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W6LIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
GELATININACTIVE INGREDIENT2G86QN327LLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
KAOLININACTIVE INGREDIENT24H4NWX5COLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
UREAINACTIVE INGREDIENT8W8T17847WLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]4
LIDOCAINEACTIVE INGREDIENT98PI200987LIDODERM (LIDOCAINE) PATCH [PHYSICIANS TOTAL CARE, INC.]2
LIDOCAINEACTIVE MOIETY98PI200987LIDODERM (LIDOCAINE) PATCH [PHYSICIANS TOTAL CARE, INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDODERM (LIDOCAINE) PATCH [PHYSICIANS TOTAL CARE, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDODERM (LIDOCAINE) PATCH [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LLIDODERM (LIDOCAINE) PATCH [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDODERM (LIDOCAINE) PATCH [PHYSICIANS TOTAL CARE, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDODERM (LIDOCAINE) PATCH [PHYSICIANS TOTAL CARE, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LIDODERM (LIDOCAINE) PATCH [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIDODERM (LIDOCAINE) PATCH [PHYSICIANS TOTAL CARE, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDODERM (LIDOCAINE) PATCH [PHYSICIANS TOTAL CARE, INC.]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HLIDODERM (LIDOCAINE) PATCH [PHYSICIANS TOTAL CARE, INC.]2
UREAINACTIVE INGREDIENT8W8T17847WLIDODERM (LIDOCAINE) PATCH [PHYSICIANS TOTAL CARE, INC.]2
LIDOCAINEACTIVE INGREDIENT98PI200987LIDODERM (LIDOCAINE) PATCH [UNIT DOSE SERVICES]1
LIDOCAINEACTIVE INGREDIENT98PI200987LIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]1
LIDOCAINEACTIVE INGREDIENT98PI200987LIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
LIDOCAINEACTIVE INGREDIENT98PI200987LIDODERM (LIDOCAINE) PATCH [DISPENSING SOLUTIONS, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987LIDODERM (LIDOCAINE) PATCH [UNIT DOSE SERVICES]1
LIDOCAINEACTIVE MOIETY98PI200987LIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]1
LIDOCAINEACTIVE MOIETY98PI200987LIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
LIDOCAINEACTIVE MOIETY98PI200987LIDODERM (LIDOCAINE) PATCH [DISPENSING SOLUTIONS, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDODERM (LIDOCAINE) PATCH [UNIT DOSE SERVICES]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDODERM (LIDOCAINE) PATCH [DISPENSING SOLUTIONS, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W6LIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDODERM (LIDOCAINE) PATCH [UNIT DOSE SERVICES]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDODERM (LIDOCAINE) PATCH [DISPENSING SOLUTIONS, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LLIDODERM (LIDOCAINE) PATCH [UNIT DOSE SERVICES]1
GELATININACTIVE INGREDIENT2G86QN327LLIDODERM (LIDOCAINE) PATCH [DISPENSING SOLUTIONS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LLIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDODERM (LIDOCAINE) PATCH [UNIT DOSE SERVICES]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDODERM (LIDOCAINE) PATCH [DISPENSING SOLUTIONS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
KAOLININACTIVE INGREDIENT24H4NWX5COLIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDODERM (LIDOCAINE) PATCH [UNIT DOSE SERVICES]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDODERM (LIDOCAINE) PATCH [DISPENSING SOLUTIONS, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LIDODERM (LIDOCAINE) PATCH [UNIT DOSE SERVICES]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990LIDODERM (LIDOCAINE) PATCH [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIDODERM (LIDOCAINE) PATCH [UNIT DOSE SERVICES]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LIDODERM (LIDOCAINE) PATCH [DISPENSING SOLUTIONS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDODERM (LIDOCAINE) PATCH [DISPENSING SOLUTIONS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDODERM (LIDOCAINE) PATCH [UNIT DOSE SERVICES]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HLIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HLIDODERM (LIDOCAINE) PATCH [UNIT DOSE SERVICES]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HLIDODERM (LIDOCAINE) PATCH [DISPENSING SOLUTIONS, INC.]1
UREAINACTIVE INGREDIENT8W8T17847WLIDODERM (LIDOCAINE) PATCH [STAT RX USA LLC]1
UREAINACTIVE INGREDIENT8W8T17847WLIDODERM (LIDOCAINE) PATCH [REBEL DISTRIBUTORS CORP.]1
UREAINACTIVE INGREDIENT8W8T17847WLIDODERM (LIDOCAINE) PATCH [DISPENSING SOLUTIONS, INC.]1
UREAINACTIVE INGREDIENT8W8T17847WLIDODERM (LIDOCAINE) PATCH [UNIT DOSE SERVICES]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745091lidocaine 5 % Medicated PatchPSNd499efc5-8bc3-4dbc-9d85-fae57dd9263c5
1011705Lidoderm 5 % Medicated PatchPSNd499efc5-8bc3-4dbc-9d85-fae57dd9263c5
1011705lidocaine 0.05 MG/MG Medicated Patch [Lidoderm]SBDd499efc5-8bc3-4dbc-9d85-fae57dd9263c5
1745091lidocaine 0.05 MG/MG Medicated PatchSCDd499efc5-8bc3-4dbc-9d85-fae57dd9263c5
1745091lidocaine 5 % Medicated PatchSYd499efc5-8bc3-4dbc-9d85-fae57dd9263c5
1011705Lidoderm 0.05 MG/MG Medicated PatchSYd499efc5-8bc3-4dbc-9d85-fae57dd9263c5
1011705Lidoderm 5 % Medicated PatchSYd499efc5-8bc3-4dbc-9d85-fae57dd9263c5
1745091lidocaine 5 % Medicated PatchPSN4e45cd6c-a777-4100-943b-985058bff75a4
1011705Lidoderm 5 % Medicated PatchPSN4e45cd6c-a777-4100-943b-985058bff75a4
1011705lidocaine 0.05 MG/MG Medicated Patch [Lidoderm]SBD4e45cd6c-a777-4100-943b-985058bff75a4
1745091lidocaine 0.05 MG/MG Medicated PatchSCD4e45cd6c-a777-4100-943b-985058bff75a4
1745091lidocaine 5 % Medicated PatchSY4e45cd6c-a777-4100-943b-985058bff75a4
1011705Lidoderm 0.05 MG/MG Medicated PatchSY4e45cd6c-a777-4100-943b-985058bff75a4
1011705Lidoderm 5 % Medicated PatchSY4e45cd6c-a777-4100-943b-985058bff75a4
1745091lidocaine 5 % Medicated PatchPSN5ffefcdc-ebfa-4dc8-b484-719658da9d6d2
1011705Lidoderm 5 % Medicated PatchPSN5ffefcdc-ebfa-4dc8-b484-719658da9d6d2
1011705lidocaine 0.05 MG/MG Medicated Patch [Lidoderm]SBD5ffefcdc-ebfa-4dc8-b484-719658da9d6d2
1745091lidocaine 0.05 MG/MG Medicated PatchSCD5ffefcdc-ebfa-4dc8-b484-719658da9d6d2
1745091lidocaine 5 % Medicated PatchSY5ffefcdc-ebfa-4dc8-b484-719658da9d6d2
1011705Lidoderm 0.05 MG/MG Medicated PatchSY5ffefcdc-ebfa-4dc8-b484-719658da9d6d2
1011705Lidoderm 5 % Medicated PatchSY5ffefcdc-ebfa-4dc8-b484-719658da9d6d2
1745091lidocaine 5 % Medicated PatchPSN55be87b4-a69b-4bfd-bf92-2949ec5e5dab1
1745091lidocaine 5 % Medicated PatchPSN18e420b9-0fd1-48d9-9a23-c1e29a5f629f1
1745091lidocaine 5 % Medicated PatchPSN7ab30afe-4de2-4fe5-9e62-a484683fb93f1
1011705Lidoderm 5 % Medicated PatchPSN18e420b9-0fd1-48d9-9a23-c1e29a5f629f1
1011705Lidoderm 5 % Medicated PatchPSN7ab30afe-4de2-4fe5-9e62-a484683fb93f1
1011705Lidoderm 5 % Medicated PatchPSN55be87b4-a69b-4bfd-bf92-2949ec5e5dab1
1011705lidocaine 0.05 MG/MG Medicated Patch [Lidoderm]SBD7ab30afe-4de2-4fe5-9e62-a484683fb93f1
1011705lidocaine 0.05 MG/MG Medicated Patch [Lidoderm]SBD18e420b9-0fd1-48d9-9a23-c1e29a5f629f1
1011705lidocaine 0.05 MG/MG Medicated Patch [Lidoderm]SBD55be87b4-a69b-4bfd-bf92-2949ec5e5dab1
1745091lidocaine 0.05 MG/MG Medicated PatchSCD7ab30afe-4de2-4fe5-9e62-a484683fb93f1
1745091lidocaine 0.05 MG/MG Medicated PatchSCD55be87b4-a69b-4bfd-bf92-2949ec5e5dab1
1745091lidocaine 0.05 MG/MG Medicated PatchSCD18e420b9-0fd1-48d9-9a23-c1e29a5f629f1
1745091lidocaine 5 % Medicated PatchSY7ab30afe-4de2-4fe5-9e62-a484683fb93f1
1745091lidocaine 5 % Medicated PatchSY55be87b4-a69b-4bfd-bf92-2949ec5e5dab1
1745091lidocaine 5 % Medicated PatchSY18e420b9-0fd1-48d9-9a23-c1e29a5f629f1
1011705Lidoderm 0.05 MG/MG Medicated PatchSY7ab30afe-4de2-4fe5-9e62-a484683fb93f1
1011705Lidoderm 0.05 MG/MG Medicated PatchSY18e420b9-0fd1-48d9-9a23-c1e29a5f629f1
1011705Lidoderm 0.05 MG/MG Medicated PatchSY55be87b4-a69b-4bfd-bf92-2949ec5e5dab1
1011705Lidoderm 5 % Medicated PatchSY18e420b9-0fd1-48d9-9a23-c1e29a5f629f1
1011705Lidoderm 5 % Medicated PatchSY7ab30afe-4de2-4fe5-9e62-a484683fb93f1
1011705Lidoderm 5 % Medicated PatchSY55be87b4-a69b-4bfd-bf92-2949ec5e5dab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63481-687-066348106870630 POUCH in 1 CARTON (63481-687-06) > 1 g in 1 POUCH (63481-687-01) 30 pouch1999-03-200000-00-00NoNoCurrent