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 161 of 186 · 3,703 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PAIN RELIEF Gel-Roll On	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bc2a14-6bda-428c-e053-2995a90a4ced	2024-04-29	Warnings	Exact identifier unii: L7T10EIP3A
PAIN RELIEF Gel-Tube	MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f0bec1d4-2e18-4519-e053-2a95a90a1bbb	2024-04-29	Warnings	Exact identifier unii: L7T10EIP3A
CHERRY COUGH DROPS 50CT	MENTHOL, UNSPECIFIED FORM	JHK Inc dba American Safety & First Aid	2f54b9c1-3a37-48fd-b964-6aa2631b8e62	2024-04-24	Warnings	Exact identifier unii: L7T10EIP3A
PEMF Optimizer	AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM	Deseret Biologicals, Inc.	97d57469-4c5b-4d3f-9398-3a1a6617a649	2024-04-23	Warnings	Exact identifier unii: 059QF0KO0R
Cold Therapy Pain Relief	MENTHOL, UNSPECIFIED FORM	Walgreen Co.	ede15818-5d17-477d-a8be-7b36bb0770a6	2024-04-22	Warnings	Exact identifier unii: L7T10EIP3A
Walgreens Cold Therapy Pain Relief Patch	MENTHOL 5%	Walgreens Company	e33c90d1-2729-970f-e053-2995a90ad97a	2024-04-18	Warnings	Exact identifier unii: L7T10EIP3A
HealthWise Cold Therapy Pain Relief Patch	MENTHOL	Veridian Healthcare	0ce356e0-90a3-ad52-e063-6294a90a404a	2024-04-18	Warnings	Exact identifier unii: L7T10EIP3A
HealthWise 3x Medicated Pain Relief Patch	CAMPHOR,MENTHOL, METHYL SALICYLATE	Veridian Healthcare	164d4d62-00c0-e06d-e063-6294a90abd73	2024-04-17	Warnings	Exact identifier unii: LAV5U5022Y
PUREGEN LABS Maximum Strength Lidocaine	LIDOCAINE	Advanced Rx LLC	f4f89582-49e6-424a-bea7-0694484a7c99	2024-04-11	Warnings	Exact identifier unii: 98PI200987
Sterile Water	WATER	Hikma Pharmaceuticals USA Inc.	78ef7ad3-451d-43d0-a9b6-5cf0aadca003	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	B. Braun Medical Inc.	8fc8d87a-3951-4ac5-97df-c161ffc90475	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	1592a40a-a647-34bd-e063-6394a90a0a10	2024-04-08	Warnings	Exact identifier unii: 98PI200987
Robitussin Medi-Soothers	DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL	Haleon US Holdings LLC	4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5	2024-04-06	Warnings	Exact identifier unii: L7T10EIP3A
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	b4db5684-988f-44c4-a81e-5c04b8b0f6e7	2024-04-05	Warnings, Adverse reactions	Exact identifier unii: 98PI200987
PREPARATION H Maximum Strength	GLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCL	Haleon US Holdings LLC	7cc03d2e-e708-589a-d9bb-58ebbda989c0	2024-04-05	Warnings	Exact identifier unii: PDC6A3C0OX
Menticam	CAMPHOR, MENTHOL, METHYL SALICYLATE	PureTek Corporation	081837a8-9669-be1f-e063-6394a90a9d20	2024-04-05	Warnings	Exact identifier unii: L7T10EIP3A unii: LAV5U5022Y
Lidocaine	LIDOCAINE	Bryant Ranch Prepack	19c585f3-e635-44d4-8eb0-14529eb34dca	2024-04-03	Warnings, Adverse reactions	Exact identifier unii: 98PI200987
Pain Relieving Liniment	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	97a0c839-0927-4e54-aee2-ded2016ac4a0	2024-04-02	Warnings	Exact identifier unii: L7T10EIP3A
Eye Wash	WATER	M-star (Hubei) Health&Care Products Co., Ltd.	71706039-e250-4f08-9687-71b2928c4e46	2024-04-01	Warnings	Exact identifier unii: 059QF0KO0R
HealthWise Roll-On Lidocaine Pain Relief Liquid Lavender Scent	LIDOCAINE HCI	Veridian Healthcare	150d3e54-5c8d-19ef-e063-6394a90a70c2	2024-04-01	Warnings	Exact identifier unii: 98PI200987

Reported adverse events (FAERS/openFDA)#

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