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
Label	Manufacturer	Effective date	Type
LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%	Preferred Pharmaceuticals Inc.	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL
lidocaine - E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL
LIVIXIL PAK - Alvix Laboratories, LLC	Alvix Laboratories, LLC	2019-05-28	HUMAN PRESCRIPTION DRUG LABEL
PainGo KFT - International Brand Management, LLC	International Brand Management, LLC	2017-03-08	HUMAN PRESCRIPTION DRUG LABEL
General Surgery Kit	Centurion Medical Products \| E. Fougera & Co.	2013-10-02	MEDICAL DEVICE
LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%	Physicians Total Care, Inc.	2010-10-01	HUMAN PRESCRIPTION DRUG LABEL
Lidocaine and Prilocaine - Rebel Distributors Corp	Rebel Distributors Corp	2010-10-01	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0168-0357-30	2024-10-07	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2024-10-07	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2024-10-07	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2024-10-07	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2024-10-07	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2024-10-07	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2024-07-30	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2024-07-30	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2024-07-30	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2024-07-30	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2024-07-30	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2024-07-30	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2024-01-30	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2024-01-30	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2024-01-30	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2024-01-30	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2024-01-30	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2024-01-30	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2020-10-13	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2020-10-13	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2020-10-13	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2020-10-13	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2020-10-13	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2020-10-13	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2020-09-27	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2020-09-27	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2020-09-27	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2020-09-27	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2020-09-27	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2020-09-27	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2020-09-25	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2020-09-25	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2020-09-25	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2020-09-25	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2020-09-25	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2020-09-25	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2020-07-22	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-30	2020-07-22	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2020-07-22	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-55	2020-07-22	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2020-07-22	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
0168-0357-56	2020-07-22	LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0168-0357-05	Lidocaine and Prilocaine	5 g in 1 TUBE	CREAM	5		21
0168-0357-30	Lidocaine and Prilocaine	30 g in 1 TUBE	CREAM	30		21
0168-0357-30	Lidocaine and Prilocaine	1 in 1 CARTON	CREAM	1		21
0168-0357-55	Lidocaine and Prilocaine	1 in 1 CARTON	CREAM	1		21
0168-0357-56	Lidocaine and Prilocaine	1 in 1 CARTON	CREAM	1		21
0168-0357-30	PainGo KFT	30 g in 1 TUBE	CREAM	30 g	25 mg in 1g	13
0168-0357-55	General Surgery Tray	5 g in 1 TUBE	CREAM	5 g	25 mg in 1g	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0168-0357	LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	19	Current NDC, Legacy NDC, 5 package rows	20241009_833cd52c-6470-49c4-937f-1393971f4db9.zip
0168-0357	PAINGO KFT (PRILOCAINE, LIDOCAINE, METHYL SALICYLATE, MENTHOL) KIT [INTERNATIONAL BRAND MANAGEMENT, LLC]	13	Current NDC, Legacy NDC	20170308_cd9ca2e8-14fb-4d1e-bb31-7f354666e563.zip
0168-0357	GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]	1	Current NDC, Legacy NDC	20131112_88c0ffed-a553-444e-9800-6c8c80df7690.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0357-30	GM - Gram	0168-0357	5044f417-d8a0-4b92-96d6-a36f07f67c5b	1	2012-07-24
0168-0357-55	GM - Gram	0168-0357	8471d1ad-8232-4e9d-8410-f66313faba05	1	2012-07-24
0168-0357-56	EA - Each	0168-0357	0dc71ab3-ee35-4018-87e6-891c0ebe73aa	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lidocaine	ACTIVE INGREDIENT	98PI200987	LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
prilocaine	ACTIVE INGREDIENT	046O35D44R	LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
lidocaine	ACTIVE MOIETY	98PI200987	LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
prilocaine	ACTIVE MOIETY	046O35D44R	LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
water	INACTIVE INGREDIENT	059QF0KO0R	LIDOCAINE AND PRILOCAINE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	8
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]	3
PRILOCAINE	ACTIVE INGREDIENT	046O35D44R	LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]	3
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]	3
PRILOCAINE	ACTIVE MOIETY	046O35D44R	LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]	3
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]	3
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]	3
PEG-55 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	0WZF1506N9	LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	LIVIXIL PAK (LIDOCAINE 2.5% AND PRILOCAINE 2.5%) KIT [ALVIX LABORATORIES, LLC]	3
lidocaine	ACTIVE INGREDIENT	98PI200987	LIDOCAINE AND PRILOCAINE CREAM [PHYSICIANS TOTAL CARE, INC.]	1
lidocaine	ACTIVE INGREDIENT	98PI200987	LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]	1
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]	1
prilocaine	ACTIVE INGREDIENT	046O35D44R	LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]	1
prilocaine	ACTIVE INGREDIENT	046O35D44R	LIDOCAINE AND PRILOCAINE CREAM [PHYSICIANS TOTAL CARE, INC.]	1
PRILOCAINE	ACTIVE INGREDIENT	046O35D44R	GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]	1
lidocaine	ACTIVE MOIETY	98PI200987	LIDOCAINE AND PRILOCAINE CREAM [PHYSICIANS TOTAL CARE, INC.]	1
lidocaine	ACTIVE MOIETY	98PI200987	LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]	1
prilocaine	ACTIVE MOIETY	046O35D44R	LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]	1
PRILOCAINE	ACTIVE MOIETY	046O35D44R	GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]	1
prilocaine	ACTIVE MOIETY	046O35D44R	LIDOCAINE AND PRILOCAINE CREAM [PHYSICIANS TOTAL CARE, INC.]	1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	LIDOCAINE AND PRILOCAINE CREAM [PHYSICIANS TOTAL CARE, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	GENERAL SURGERY TRAY () KIT [CENTURION MEDICAL PRODUCTS]	1
water	INACTIVE INGREDIENT	059QF0KO0R	LIDOCAINE AND PRILOCAINE CREAM [REBEL DISTRIBUTORS CORP]	1
water	INACTIVE INGREDIENT	059QF0KO0R	LIDOCAINE 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 133 of 186 · 3,703 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f93cbde5-329a-f880-e053-6294a90a1af2	2024-12-31	Warnings, Adverse reactions	Exact identifier unii: 98PI200987
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	f94d388c-8471-885b-e053-6294a90ab67a	2024-12-31	Warnings, Adverse reactions	Exact identifier unii: 98PI200987
Lidocaine	LIDOCAINE	Advanced Rx Pharmacy of Tennessee, LLC	01cb19a4-ce22-144d-e063-6294a90a8aa3	2024-12-31	Warnings	Exact identifier unii: 98PI200987
Satohap Lidocaine 4% Menthol 1% Pain Relieving Cream	LIDOCAINE, MENTHOL	Sato Pharmaceutical Co., Ltd.	2251e96b-d050-4ec2-a6b9-6659610885bf	2024-12-30	Warnings	Exact identifier unii: 98PI200987
Lidocaine and prilocaine	LIDOCAINE AND PRILOCAINE	Zydus Lifesciences Limited	f85ec4ed-4a1b-4680-ace1-b2a0b1114af5	2024-12-30		Exact identifier rxcui: 197877 unii: 98PI200987 unii: 046O35D44R
Comforte Menstrual Cramp Relief Cream	MENTHOL	PMS4PMS LLC	c121537e-3333-4f35-8c77-20086158dff4	2024-12-26	Warnings	Exact identifier unii: L7T10EIP3A
N-Labs Arcticzen Pain Relief Knee	CAMPHOR (SYNTHETIC), MENTHOL	NUTRIOMO LABS PTE. LTD	05ee574a-854c-4a77-be77-082055075c4d	2024-12-26	Warnings	Exact identifier unii: L7T10EIP3A
Lidocaine	LIDOCAINE	Asclemed USA, Inc.	f7ada189-7463-4bc7-83e7-f140558ecacf	2024-12-25	Warnings, Adverse reactions	Exact identifier unii: 98PI200987
Tucks Triple Relief Hemorrhoidal	WHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Blistex Inc.	bf892e90-2d9b-4fa0-8ee4-8a2736be6c30	2024-12-24	Warnings	Exact identifier unii: PDC6A3C0OX
GNP Anti Itch	CAMPHOR, MENTHOL	AMERISOURCEBERGEN DRUG CORPORATION	b4f2d6f7-2287-47d8-e053-2995a90ae335	2024-12-23	Warnings	Exact identifier unii: L7T10EIP3A
cool and heat pain relieving liquid	MENTHOL	Bionpharma Inc.	ec6f59d8-45c5-46a0-e053-2995a90a239f	2024-12-23	Warnings	Exact identifier unii: L7T10EIP3A
FOOT WORKS MAXIMUM CRACKED HEEL	BENZALKONIUM CHLORIDE, LIDOCAINE	COSMAX USA, CORPORATION	29f92230-d1d4-5e94-e063-6294a90af812	2024-12-23	Warnings	Exact identifier unii: 98PI200987
Pedia-Lax	GLYCERIN	C.B. Fleet Company, Inc.	4e15f6ca-a40c-485f-be3f-07c2ed7cb498	2024-12-23	Warnings	Exact identifier unii: PDC6A3C0OX
OASIS Tears Preservative-Free Lubricant Eye	GLYCERIN	OASIS Medical, Inc.	d9d71b1d-82a6-42e7-9ef2-2d041daef936	2024-12-23	Warnings	Exact identifier unii: PDC6A3C0OX
Veneno de Abeja Aceite De Vibora Brand	METHYL SALICYLATE	Miramar Cosmetics, Inc DBA Miramar Lab	a6c4889c-e7a9-44b9-bd9a-70fd6e8c4825	2024-12-23	Warnings	Exact identifier unii: LAV5U5022Y
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	44d3638d-f29b-0e01-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
Rhuli Gel	CAMPHOR, MENTHOL	Trifecta Pharmaceuticals USA, LLC.	4fbb3c23-ed47-336e-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Halls Honey Vanilla	MENTHOL	Mondelez Global LLC	8e94a1b8-8915-4595-b097-8a0a319d54aa	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Halls Sugar Free Mentho-Lyptus	MENTHOL	Mondelez Global LLC	96046858-c57b-426e-8279-91b35e05bcdb	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
DCH Cooling Pain Relief	MENTHOL 10.5%	Derma Care Research Labs, LLC	00dcdae0-c744-8402-e063-6294a90a12f8	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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