FDA.reportPublic FDA data

NDC 0168-0357-05 - Lidocaine and Prilocaine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0168-0357
Requested NDC
0168-0357-05
Package NDCs from labels
0168-0357-05, 0168-0357-55, 0168-0357-56, 0168-0357-30
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-05-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%Preferred Pharmaceuticals Inc.2026-05-21HUMAN PRESCRIPTION DRUG LABEL
lidocaine - E. Fougera & Co. a division of Fougera Pharmaceuticals, LLCE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC2026-01-28HUMAN PRESCRIPTION DRUG LABEL
LIVIXIL PAK - Alvix Laboratories, LLCAlvix Laboratories, LLC2019-05-28HUMAN PRESCRIPTION DRUG LABEL
PainGo KFT - International Brand Management, LLCInternational Brand Management, LLC2017-03-08HUMAN PRESCRIPTION DRUG LABEL
General Surgery KitCenturion Medical Products | E. Fougera & Co.2013-10-02MEDICAL DEVICE
LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%Physicians Total Care, Inc.2010-10-01HUMAN PRESCRIPTION DRUG LABEL
Lidocaine and Prilocaine - Rebel Distributors CorpRebel Distributors Corp2010-10-01HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0168-0357-302024-10-07LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302024-10-07LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552024-10-07LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552024-10-07LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562024-10-07LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562024-10-07LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302024-07-30LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302024-07-30LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552024-07-30LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552024-07-30LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562024-07-30LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562024-07-30LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302024-01-30LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302024-01-30LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552024-01-30LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552024-01-30LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562024-01-30LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562024-01-30LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-10-13LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-10-13LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-10-13LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-10-13LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-10-13LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-10-13LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-09-27LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-09-27LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-09-27LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-09-27LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-09-27LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-09-27LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-09-25LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-09-25LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-09-25LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-09-25LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-09-25LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-09-25LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-07-22LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-302020-07-22LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-07-22LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-552020-07-22LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-07-22LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-562020-07-22LIDOCAINE 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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 99 of 187 · 3,740 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freegells Cough Drops Menthol Honey Lemon 80ctMENTHOLR.L. ALBERT & SON, INC61deea94-d0a9-4563-926b-53f255a7c4252025-10-08WarningsExact identifier
unii: L7T10EIP3A
FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPSMENTHOLR.L. ALBERT & SON, INCc6b36350-386b-4346-bef0-a37ec11319c02025-10-08WarningsExact identifier
unii: L7T10EIP3A
COOLING PAIN RELIEFMENTHOL, CAMPHORSUNSET NOVELTIES, INC3a9019b1-8798-1ef9-e063-6394a90a09a42025-10-08WarningsExact identifier
unii: L7T10EIP3A
Pain free IVLIDOCAINESambria Pharmaceuticals, LLC7aa4cb20-d452-417f-afdb-307df754ed752025-10-07WarningsExact identifier
unii: 98PI200987
HealthWise Pain Relief PatchMENTHOL, METHYL SALICYLATEVeridian Healthcareb65932fd-ee9f-4fa2-b842-01e0f54133c92025-10-07WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AREX SINSIN PASCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.2013ea44-e2ea-4b36-bddb-7f64163284b62025-10-07WarningsExact identifier
unii: LAV5U5022Y
SINSINPAS LIDOCAINE PAIN RELIEVINGLIDOCAINESinsin Pharmaceutical Co., Ltd.82c0a036-8750-5b3d-e053-2a91aa0a18152025-10-07WarningsExact identifier
unii: 98PI200987
SINSIN MULPASL-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR, CHLORPHENIRAMINE MALEATE, THYMOLSinsin Pharmaceutical Co., Ltd.81baffcb-c08e-4616-e053-2a91aa0aaf152025-10-07WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Arex Sinsin PasCAMPHOR, MENTHA OIL, MENTHOL, METHYL SALICYLATE, ZINC OXIDESinsin Pharmaceutical Co., Ltd.a851854a-5dfe-4bd5-95f6-67c3f13f11872025-10-07WarningsExact identifier
unii: LAV5U5022Y
Sinsinpas Arex Flex Gel Pain Relieving PatchL-MENTHOLSinsin Pharmaceutical Co., Ltd.1758ef9b-4fac-4066-e063-6394a90a8cc32025-10-07WarningsExact identifier
unii: LAV5U5022Y
Methyl Salicylate 40% Topical OilMETHYL SALICYLATEFORREAL PHARMACEUTICALS LLC10e15734-9783-4153-b7b6-a4d0f57678b62025-10-07WarningsExact identifier
unii: LAV5U5022Y
Quality Choice Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc2025-10-06WarningsExact identifier
unii: L7T10EIP3A
LidocannaLIDOCAINEPHARMACURE LLCb28ebbb6-1112-4750-a2bb-f96b03fabe6e2025-10-06WarningsExact identifier
unii: 98PI200987
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLC66b13044-69d2-4559-9e65-8a4c601c077a2025-10-06WarningsExact identifier
unii: LAV5U5022Y
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLCf119a1bd-095f-41f5-86d5-c0ee4f19fd2c2025-10-06WarningsExact identifier
unii: LAV5U5022Y
LIDOCAINELIDOCAINEPHARMACURE LLC31d5e5c9-6ec4-4496-8a4c-cca39a2cbe322025-10-06WarningsExact identifier
unii: 98PI200987
Halls Sugar Free Honey LemonMENTHOLMondelez Global LLC2b19fdd2-8088-47f2-be20-f220a6b825fc2025-10-06WarningsExact identifier
unii: L7T10EIP3A
Tempo coolMENTHOLThe Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.Ebd642389-6d03-4e09-a71c-312fb90eae892025-10-06WarningsExact identifier
unii: L7T10EIP3A
Menthopatch HotMENTHOL , CAPSICUM EXTRACTTHE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID3d289be3-c237-4065-a8ac-e8c2e51b76a52025-10-06WarningsExact identifier
unii: L7T10EIP3A
Mentho patch coolMENTHOLTHE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID02251a4a-fc6f-42c9-a244-6f4835de5edd2025-10-06WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.