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 40 of 187 · 3,740 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tartar control plus	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	The Kroger Co.	0407d06e-a8d4-4522-8213-3a7a0c5e336e	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
MEDISTIK PROFESSIONAL DUAL ACTION	MENTHOL, METHYL SALICYLATE, EUCALUPTUS	Natureteq Inc.	99c7f08a-ab14-4371-9147-189f75cb6633	2026-02-27	Warnings	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
Mouth Rinse	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	The Kroger Co.	f6ccdce2-ae3c-44f7-803d-5a135a7a7e8e	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
Antiseptic Mouthrinse	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Walmart Inc.	a8daefba-b985-4ef9-b900-e5647324662e	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
Antiseptic	EUCALYPTOL, MENTHOL, METYL SALICYLATE, THYMOL	Walmart Inc.	404dfa0f-8ac1-463a-9e10-fc87f7069795	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
Antispetic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Walmart Inc.	d2515c9c-79b4-4874-be6e-fe8312477fc8	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
Aloe Vera Gel	LIDOCAINE HCL, MENTHOL	Walmart Inc.	309dcf5b-7166-976a-e063-6394a90af952	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: L7T10EIP3A
Tartar control plus	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Walmart Inc.	4da4ecf6-038e-4a64-83f7-c29d70e83174	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
Lidovara	LIDOVARA	Oncora Pharma, LLC	93a33939-80e1-4d6d-aa6d-96ca03d95410	2026-02-27	Warnings	Exact identifier unii: 98PI200987
ASYSTEM Radical Relief Gel Roll-On	MENTHOL, METHYL SALICYLATE	Cosco International, Inc.	7239733e-5510-4a63-96c3-dd88b4a431a3	2026-02-27	Warnings	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
Lidexa	LIDEXA	Oncora Pharma, LLC	46d6b3b8-3a9a-44c2-b807-a32f24945f4a	2026-02-27	Warnings, Adverse reactions	Exact identifier unii: 98PI200987
Lidomax	LIDOMAX	Oncora Pharma, LLC	7f9e9a1e-f2a8-4428-ab9d-9c5b070991eb	2026-02-27	Warnings	Exact identifier unii: 98PI200987
Icy Hot Pro Pain Massaging Balm	CAMPHOR AND MENTHOL	Chattem, Inc.	09e2b0cb-5186-4f9c-b256-edaced4ca014	2026-02-27	Warnings	Exact identifier unii: L7T10EIP3A
Lidocaine Pain Relief	LIDOCAINE PAIN RELIEF	PAI Holdings, LLC dba PAI Pharma	963978de-8295-47ee-9b06-64c3521aa994	2026-02-26	Warnings	Exact identifier unii: 98PI200987
Dermatool Hemorrhoidal	GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCL	Papalo Group LLC	4bc06f41-7733-ebd0-e063-6294a90af7a8	2026-02-26	Warnings	Exact identifier unii: 98PI200987 unii: PDC6A3C0OX
Advanced Pain Relief Cream With 5 % Natural Menthol	MENTHOL	Allure Labs	4bab9c43-86d4-dad2-e063-6394a90ac095	2026-02-25	Warnings	Exact identifier unii: L7T10EIP3A
Walgreens Pain Relieving Patch	MENTHOL, CAMPHOR, METHYL SALICYLATE	Walgreen Co.	4223c74a-12fb-51a3-e063-6294a90a0deb	2026-02-25	Warnings	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
Advanced Pain Relief Roll-On Gel With 5% Natural Menthol	MENTHOL	Allure Labs	4bad597f-acb2-a122-e063-6394a90a9fcf	2026-02-25	Warnings	Exact identifier unii: L7T10EIP3A
Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy	LIDOCAINE	InterMed Laboratories Private Limited	4bade8a9-43bd-b649-e063-6294a90a81da	2026-02-25	Warnings	Exact identifier unii: 98PI200987
Antispetic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Better Living Brands, LLC	c2c6a591-c2fd-47ac-bf80-41e6030fdd75	2026-02-24	Warnings, Adverse reactions	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y

Reported adverse events (FAERS/openFDA)#

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