FDA.reportPublic FDA data

Lidocaine and Prilocaine

Product NDC
0168-0357
11-digit product format
001680357
Labeler code
0168
Product ID
0168-0357_73a2a608-dd5c-4357-85f3-00358b9c6ccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine and prilocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA076453
Marketing category
ANDA
Marketing start
2003-08-18
Substance
LIDOCAINE; PRILOCAINE
Active strength
25; 25 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], 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 and Prilocaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE25 mg/g
PRILOCAINE25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987, 046O35D44R
Rxcui197877

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0357-302024-10-07C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302024-10-07C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552024-10-07C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552024-10-07C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562024-10-07C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562024-10-07C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302024-07-30C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302024-07-30C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552024-07-30C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552024-07-30C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562024-07-30C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562024-07-30C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302024-01-30C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302024-01-30C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552024-01-30C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552024-01-30C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562024-01-30C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562024-01-30C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-10-13C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-10-13C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-10-13C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-10-13C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-10-13C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-10-13C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-09-27C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-09-27C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-09-27C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-09-27C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-09-27C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-09-27C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-09-25C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-09-25C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-09-25C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-09-25C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-09-25C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-09-25C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-07-22C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-07-22C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-07-22C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-07-22C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-07-22C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-07-22C16284748780-1ab0e2407-28e7-f274-e053-dbdaa90a6471LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0168-0357-05Lidocaine and Prilocaine5 g in 1 TUBECREAM521
0168-0357-30Lidocaine and Prilocaine30 g in 1 TUBECREAM3021
0168-0357-30Lidocaine and Prilocaine1 in 1 CARTONCREAM121
0168-0357-55Lidocaine and Prilocaine1 in 1 CARTONCREAM121
0168-0357-56Lidocaine and Prilocaine1 in 1 CARTONCREAM121
0168-0357-30PainGo KFT30 g in 1 TUBECREAM30 g25 mg in 1g13
0168-0357-55General Surgery Tray5 g in 1 TUBECREAM5 g25 mg in 1g1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0357-30GM - Gram0168-03575044f417-d8a0-4b92-96d6-a36f07f67c5b12012-07-24
0168-0357-55GM - Gram0168-03578471d1ad-8232-4e9d-8410-f66313faba0512012-07-24
0168-0357-56EA - Each0168-03570dc71ab3-ee35-4018-87e6-891c0ebe73aa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
lidocaineACTIVE INGREDIENT98PI200987LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
prilocaineACTIVE INGREDIENT046O35D44RLIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
lidocaineACTIVE MOIETY98PI200987LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
prilocaineACTIVE MOIETY046O35D44RLIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
sodium hydroxideINACTIVE INGREDIENT55X04QC32ILIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
waterINACTIVE INGREDIENT059QF0KO0RLIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]8
LIDOCAINEACTIVE INGREDIENT98PI200987LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]3
PRILOCAINEACTIVE INGREDIENT046O35D44RLIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]3
LIDOCAINEACTIVE MOIETY98PI200987LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]3
PRILOCAINEACTIVE MOIETY046O35D44RLIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]3
CARBOMER 934INACTIVE INGREDIENTZ135WT9208LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]3
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]3
PEG-55 HYDROGENATED CASTOR OILINACTIVE INGREDIENT0WZF1506N9LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RLIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]3
lidocaineACTIVE INGREDIENT98PI200987LIDOCAINE AND PRILOCAINE CREAM [PHYSICIANS TOTAL CARE, INC.]1
lidocaineACTIVE INGREDIENT98PI200987LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
LIDOCAINEACTIVE INGREDIENT98PI200987GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]1
prilocaineACTIVE INGREDIENT046O35D44RLIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
prilocaineACTIVE INGREDIENT046O35D44RLIDOCAINE AND PRILOCAINE CREAM [PHYSICIANS TOTAL CARE, INC.]1
PRILOCAINEACTIVE INGREDIENT046O35D44RGENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]1
lidocaineACTIVE MOIETY98PI200987LIDOCAINE AND PRILOCAINE CREAM [PHYSICIANS TOTAL CARE, INC.]1
lidocaineACTIVE MOIETY98PI200987LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
LIDOCAINEACTIVE MOIETY98PI200987GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]1
prilocaineACTIVE MOIETY046O35D44RLIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
PRILOCAINEACTIVE MOIETY046O35D44RGENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]1
prilocaineACTIVE MOIETY046O35D44RLIDOCAINE AND PRILOCAINE CREAM [PHYSICIANS TOTAL CARE, INC.]1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ILIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ILIDOCAINE AND PRILOCAINE CREAM [PHYSICIANS TOTAL CARE, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RGENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]1
waterINACTIVE INGREDIENT059QF0KO0RLIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RLIDOCAINE AND PRILOCAINE CREAM [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0357LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]19Current NDC, Legacy NDC, 5 package rows20241009_833cd52c-6470-49c4-937f-1393971f4db9.zip
0168-0357PAINGO KFT (PRILOCAINE, LIDOCAINE, METHYL SALICYLATE, MENTHOL) KIT [INTERNATIONAL BRAND MANAGEMENT, LLC]13Current NDC, Legacy NDC20170308_cd9ca2e8-14fb-4d1e-bb31-7f354666e563.zip
0168-0357GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]1Current NDC, Legacy NDC20131112_88c0ffed-a553-444e-9800-6c8c80df7690.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN833cd52c-6470-49c4-937f-1393971f4db921
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD833cd52c-6470-49c4-937f-1393971f4db921
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY833cd52c-6470-49c4-937f-1393971f4db921
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSNcd9ca2e8-14fb-4d1e-bb31-7f354666e56313
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSNcd9ca2e8-14fb-4d1e-bb31-7f354666e56313
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCDcd9ca2e8-14fb-4d1e-bb31-7f354666e56313
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCDcd9ca2e8-14fb-4d1e-bb31-7f354666e56313
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSYcd9ca2e8-14fb-4d1e-bb31-7f354666e56313
311500menthol 10 % / methyl salicylate 30 % Topical CreamSYcd9ca2e8-14fb-4d1e-bb31-7f354666e56313
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN1b839cb3-c1eb-3303-e054-00144ff88e887
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD1b839cb3-c1eb-3303-e054-00144ff88e887
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY1b839cb3-c1eb-3303-e054-00144ff88e887
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN69fed044-a6b8-40a7-9ba1-7fb10435ca744
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD69fed044-a6b8-40a7-9ba1-7fb10435ca744
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY69fed044-a6b8-40a7-9ba1-7fb10435ca744
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN88c0ffed-a553-444e-9800-6c8c80df76901
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSNb61c6a09-7764-4a92-93a9-a1356aeeaa9c1
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSN2a9976e3-4595-4bc5-b7f9-f4a9bd59e55d1
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD88c0ffed-a553-444e-9800-6c8c80df76901
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCDb61c6a09-7764-4a92-93a9-a1356aeeaa9c1
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCD2a9976e3-4595-4bc5-b7f9-f4a9bd59e55d1
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY88c0ffed-a553-444e-9800-6c8c80df76901
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSYb61c6a09-7764-4a92-93a9-a1356aeeaa9c1
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSY2a9976e3-4595-4bc5-b7f9-f4a9bd59e55d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0357-05001680357055 g in 1 TUBE5 gHistorical
0168-0357-30001680357301 TUBE in 1 CARTON (0168-0357-30) / 30 g in 1 TUBE1 tube2003-08-180000-00-00NoNoCurrent
0168-0357-55001680357551 TUBE in 1 CARTON (0168-0357-55) / 5 g in 1 TUBE (0168-0357-05) 1 tube2004-07-210000-00-00NoNoCurrent
0168-0357-56001680357561 TUBE in 1 CARTON (0168-0357-56) / 5 g in 1 TUBE (0168-0357-05) 1 tube2004-07-210000-00-00NoNoCurrent