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 19 of 187 · 3,740 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Lidocaine Pain Relief PatchLIDOCAINEQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)526abe69-4bbc-6e73-e063-6394a90ad25d2026-06-08WarningsExact identifier
unii: 98PI200987
Dcsily Numbing CreamLIDOCAINEShenzhen Xinxin Yunhai Technology Co., Ltd.53cab09c-6d5d-471e-e063-6294a90aa9772026-06-08WarningsExact identifier
unii: 98PI200987
lidocaineLIDOCAINENorthstar Rx LLCcde68b0c-a1ee-421d-9ca8-bc571d2990ab2026-06-08Warnings, Adverse reactionsExact identifier
unii: 98PI200987
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
unii: PDC6A3C0OX
Invisible Fit Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.537cb611-52f4-13a5-e063-6294a90a9f2a2026-06-05WarningsExact identifier
unii: ZY81Z83H0X
LidocaineLIDOCAINEREMEDYREPACK INC.9bf01533-ed83-4440-bdc4-4b45729bfc312026-06-05Warnings, Adverse reactionsExact identifier
unii: 98PI200987
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd5356cf53-935d-a02f-e063-6394a90a6e5a2026-06-05WarningsExact identifier
unii: 98PI200987
Maximum Strength Pain ReliefMENTHOL CREAMOWELL NATURALS LLC5388f2c5-8cfd-a601-e063-6294a90a2e5f2026-06-04WarningsExact identifier
unii: L7T10EIP3A
LidocaineLIDOCAINESun Pharmaceutical Industries, Inc.5eb2c62f-5352-41d7-bd66-c65b1988a9ab2026-06-03Warnings, Adverse reactionsExact identifier
unii: 98PI200987
Stye Eye Relief SerumHIPPOPHAE RHAMNOIDES SEED OIL , CALENDULA OFFICINALIS FLOWER , PERSEA GRATISSIMA (AVOCADO) OILGuangxi Keyun E-commerce Co., Ltd.535516ac-2279-7f92-e063-6294a90a04ae2026-06-03WarningsExact identifier
unii: P0M7O4Y7YD
MG PLUS ROLL ONMENTHOL ROLL ONRENU LABORATORIES, LLC535dc42f-38c7-2afc-e063-6294a90ae23d2026-06-03WarningsExact identifier
unii: L7T10EIP3A
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: PDC6A3C0OX
Mineral Ice Extreme Dry StickMENTHOLCarlin Consumer Health LLC4f81be91-92e5-1205-e063-6394a90a6e822026-06-02WarningsExact identifier
unii: L7T10EIP3A
Kalaya Extra Strength Pain Relief Gel with ArnicaMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpb6a6237d-b471-4102-b5df-fc389f5f92582026-06-02WarningsExact identifier
unii: LAV5U5022Y
Biofreeze UltraflexLIDOCAINEReckitt Benckiser LLC2655974b-a67d-9f07-e063-6294a90a54e82026-06-02WarningsExact identifier
unii: 98PI200987
Biofreeze Ultraflex PlusLIDOCAINE, MENTHOLReckitt Benckiser LLC401e1843-e9a6-fda9-e063-6294a90a30732026-06-02WarningsExact identifier
unii: 98PI200987
unii: L7T10EIP3A
Pain ReliefMENTHOL SPRAYOwell Naturals Brand, LLC534c871c-da35-6135-e063-6294a90aa9f62026-06-02WarningsExact identifier
unii: L7T10EIP3A
Fishermans Friend Mixed BerryMENTHOLLofthouse of Fleetwood53391c4d-ee2d-ade3-e063-6394a90ac77d2026-06-01WarningsExact identifier
unii: L7T10EIP3A
Orajel Medicated for Toothache and Gum, LiquidBENZOCAINE AND MENTHOLChurch & Dwight Co., Inc.ac3d605d-241d-1a6f-e053-2a95a90ae3912026-06-01WarningsExact identifier
unii: L7T10EIP3A
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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