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 90 of 187 · 3,740 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atti amour Rose Anti-Aging Repair Eye Cream	NIACINAMIDE, GLYCERIN	RIVER SUNZ co.,Ltd	1eeb9c36-5bd8-ec90-e063-6294a90ae4e1	2025-11-06	Warnings	Exact identifier unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair Serum	NIACINAMIDE, GLYCERIN	RIVER SUNZ co.,Ltd	1eb08f86-eb2a-7f29-e063-6294a90a0516	2025-11-06	Warnings	Exact identifier unii: PDC6A3C0OX
Atti amour Rose Anti-Aging Repair Moisturizing Cream	NIACINAMIDE, GLYCERIN	RIVER SUNZ co.,Ltd	1eec4cfe-d5a3-3570-e063-6294a90ac38b	2025-11-06	Warnings	Exact identifier unii: PDC6A3C0OX
PAINGEL UNGUENTO	CAMPHOR, MENTHOL	NACOR BUSINESS GROUP LLC	42fab525-b0a5-97fb-e063-6394a90aec6c	2025-11-06	Warnings	Exact identifier unii: L7T10EIP3A
PAINGEL ROLL-ON	MENTHOL	NACOR BUSINESS GROUP LLC	42fb0bdf-8bbd-bbe3-e063-6294a90a656c	2025-11-06	Warnings	Exact identifier unii: L7T10EIP3A
Coolexa	CAMPHOR, MENTHOL, METHYL SALICYLATE	Rising Pharma Holdings, Inc.	38839f29-d4ce-4684-a3c7-0bb4bf1ad594	2025-11-06	Warnings	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
Good Neighbor Pharmacy Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	AMERISOURCE BERGEN	c1843f1a-ae5b-0fdf-e053-2995a90aae38	2025-11-05	Warnings	Exact identifier unii: L7T10EIP3A
Pranicura 5	GLYCERIN, KAOLIN, CALAMINE, MENTHOL	Pranicura Products LLC	af520a58-3f3c-4d28-a41f-3ed8f74da095	2025-11-04	Warnings	Exact identifier unii: PDC6A3C0OX unii: L7T10EIP3A
Bacteriostatic Water	BACTERIOSTATIC WATER	ProPharma Distribution	42c6938e-f747-ae13-e063-6294a90a59a3	2025-11-04	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Pain Relief Gel-Roll On	LIDOCAINE AND MENTHOL	Bullet point LLC	42c70681-494b-47c9-e063-6394a90a80be	2025-11-04	Warnings	Exact identifier unii: 98PI200987 unii: L7T10EIP3A
China-Gel Topical Pain Reliever	MENTHOL AND CAMOHOR (SYNTHETIC)	China-Gel, LLC	ba6c7e97-d740-484b-8711-55fa7ab15784	2025-11-04	Warnings	Exact identifier unii: L7T10EIP3A
China-Gel	MENTHOL AND CAMOHOR (SYNTHETIC)	China-Gel, Inc.	d7c5cb17-f7a2-7f57-e053-2995a90a40f7	2025-11-04	Warnings	Exact identifier unii: L7T10EIP3A
Aulief Topical Pain Reliever	MENTHOL AND CAMOHOR	China-Gel, LLC	8647dcc3-1dbc-1093-e053-2991aa0a1ab9	2025-11-04	Warnings	Exact identifier unii: L7T10EIP3A
China-Gel Topical Pain Reliever	MENTHOL AND CAMOHOR (SYNTHETIC)	China-Gel, LLC	254abae9-ef1b-5a90-e054-00144ff88e88	2025-11-04	Warnings	Exact identifier unii: L7T10EIP3A
Pain Relief Gel-Tube	MENTHOL	Bullet point LLC	42c93789-9758-54b7-e063-6394a90ac398	2025-11-04	Warnings	Exact identifier unii: L7T10EIP3A
Menthol Drops Freegells Extra Strong Eucalyptus 30ct	MENTHOL	R.L. ALBERT & SON, INC	165a8efa-2b03-4329-99fa-3233f0af7d08	2025-11-04	Warnings	Exact identifier unii: L7T10EIP3A
Menthol Drops Freegells Extra Strong Honey Lemon 30ct	MENTHOL	R.L. ALBERT & SON, INC	f9ea46fc-0b04-444e-95fc-09aff7e7978a	2025-11-04	Warnings	Exact identifier unii: L7T10EIP3A
Tattoo care	TATTOO CARE CREAM	Perfso (HK) Co., Limited	42d0f56f-9cb1-8e19-e063-6394a90aa3e0	2025-11-04	Warnings	Exact identifier unii: ZY81Z83H0X unii: 3W1JG795YI
CORE RELIEF	CAMPHOR, MENTHOL	Copper Joint, LLC	42d17270-f58d-9d69-e063-6294a90a4078	2025-11-04	Warnings	Exact identifier unii: L7T10EIP3A
Lidocaine and Menthol	LIDOCAINE AND MENTHOL	Marcella Health	d25f25ee-79f8-49e7-9715-0aae305b73e5	2025-11-03	Warnings	Exact identifier unii: 98PI200987 unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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