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 162 of 186 · 3,703 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arnica Gel 15 Arnica Montana 1X HPUS	ARNICA GEL	VITAMEDICA, INC.	4e56ff37-e260-be18-e063-6294a90aaced	2024-03-31	Warnings	Exact identifier unii: OZ0E5Y15PZ
Meijer Pain Relief Cream	LIDOCAINE	Meijer Distribution	07ecee44-387a-cdce-e063-6294a90ab9c9	2024-03-27	Warnings	Exact identifier unii: 98PI200987
ULINE Eyewash	EYEWASH	Uline.	14545fc9-1fb4-befa-e063-6294a90a0474	2024-03-23	Warnings	Exact identifier unii: 059QF0KO0R
Sucrets	DYCLONINE HCL, MENTHOL, AND PECTIN	Insight Pharmaceuticals LLC	2a2839ea-11d3-4390-930d-0da912a9c6f5	2024-03-20	Warnings	Exact identifier unii: L7T10EIP3A
Robitussin Medi-Soothers	DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL	Haleon US Holdings LLC	6bec225e-a203-4866-b0db-b76f73a6ae25	2024-03-19	Warnings	Exact identifier unii: L7T10EIP3A
Rugby Ice Blue External Analgesic	MENTHOL, UNSPECIFIED FORM	Rugby Laboratories	2b65cb6a-4364-4770-b7b9-5c4637edd01a	2024-03-14	Warnings	Exact identifier unii: L7T10EIP3A
Leader Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	fd06d17f-4dff-42a9-a84f-904809ceb981	2024-03-13	Warnings	Exact identifier unii: L7T10EIP3A
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	EROS GLOBAL	b3495c95-ba4b-9459-e053-2a95a90a710f	2024-03-12	Warnings	Exact identifier unii: L7T10EIP3A
Trubrexa Patch ER	TRUBREXA PATCH ER	Direct_Rx	1367f190-670a-d2de-e063-6394a90abb13	2024-03-11	Warnings, Adverse reactions	Exact identifier unii: 98PI200987
Pain Reliever Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	130665d6-3de8-cb91-e063-6294a90a2083	2024-03-06	Warnings	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
Dermachange Cold Therapy	MENTHOL	Private Label Beauty and Wellness	12ef7dd8-3da3-9c87-e063-6394a90ac924	2024-03-05	Warnings	Exact identifier unii: L7T10EIP3A
Analgesic	MENTHOL	Safetec of America, Inc.	b0f4010c-995f-40e1-aa40-92760e697a61	2024-03-02	Warnings	Exact identifier unii: L7T10EIP3A
Icy Hot Advanced Relief	CAMPHOR AND MENTHOL	Chattem, Inc.	9979ff36-415b-44e4-bb10-6bf682cd00f9	2024-03-01	Warnings	Exact identifier unii: L7T10EIP3A
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	5051b650-18a4-481e-a8d7-d41d4ae51efd	2024-02-29	Warnings	Exact identifier unii: L7T10EIP3A
Amish Origins Pain Relieving Menthol 8	MENTHOL	Amish Origins Management, LLC	aaad56d5-6737-4edc-af0e-8e207695c0ec	2024-02-29	Warnings	Exact identifier unii: L7T10EIP3A
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	b120404f-5a07-4182-bb50-d943418622da	2024-02-29	Warnings	Exact identifier unii: L7T10EIP3A
Preparation H Rapid Relief	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	27db1d58-4609-4a80-af2f-9e36f10482e1	2024-02-29	Warnings	Exact identifier unii: 98PI200987
LidoPro Patch	LIDOCAINE, MENTHOL, AND METHYL SALICYLATE	Advanced Rx Pharmacy of Tennessee, LLC	128d0ba9-bc9d-af16-e063-6394a90af5ef	2024-02-29	Warnings	Exact identifier unii: 98PI200987 unii: L7T10EIP3A unii: LAV5U5022Y
Preparation H Rapid Relief	GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	699310e8-1a93-40b4-a8f4-a765be4a0cb1	2024-02-29	Warnings	Exact identifier unii: 98PI200987 unii: PDC6A3C0OX
Leader Roll-On Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	e86cba40-6b10-454d-98b3-6b547456eaad	2024-02-29	Warnings	Exact identifier unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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