LIDOCAINE AND PRILOCAINE

Product NDC: 61919-443
11-digit product format: 619190443
Labeler code: 61919
Product ID: 61919-443_9c97882c-7cdf-de65-e053-2a95a90af436
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE AND PRILOCAINE
Dosage form: CREAM
Route: TOPICAL
Labeler: DIRECT RX
Application: NDA019941
Marketing category: NDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: LIDOCAINE; PRILOCAINE
Active strength: 25 mg/g; mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-443-30	2023-01-30	C162847	48780-1	f386c64a-3046-0266-e053-dadaa90a7c1a	LIDOCAINE AND PRILOCAINE

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-443-30	LIDOCAINE AND PRILOCAINE	5 g in 1 TUBE	CREAM	5		3

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-443-30	GM - Gram	61919-443	b13f5637-d84c-44b9-8b91-a0b95862cdc3	1	2014-07-02

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lidocaine	ACTIVE INGREDIENT	98PI200987	LIDOCAINE AND PRILOCAINE CREAM [DIRECT RX]	1
prilocaine	ACTIVE INGREDIENT	046O35D44R	LIDOCAINE AND PRILOCAINE CREAM [DIRECT RX]	1
LIDOCAINE	ACTIVE MOIETY	98PI200987	LIDOCAINE AND PRILOCAINE CREAM [DIRECT RX]	1
PRILOCAINE	ACTIVE MOIETY	046O35D44R	LIDOCAINE AND PRILOCAINE CREAM [DIRECT RX]	1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	LIDOCAINE AND PRILOCAINE CREAM [DIRECT RX]	1
PEG-55 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	0WZF1506N9	LIDOCAINE AND PRILOCAINE CREAM [DIRECT RX]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	LIDOCAINE AND PRILOCAINE CREAM [DIRECT RX]	1
water	INACTIVE INGREDIENT	059QF0KO0R	LIDOCAINE AND PRILOCAINE CREAM [DIRECT RX]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-443	LIDOCAINE AND PRILOCAINE CREAM [DIRECT RX]	3	Legacy NDC, 1 package rows	20200121_c05f3803-92ae-42b7-8248-933bd92d6116.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
98PI200987	LIDOCAINE	137-58-6	LIDOCAINE
046O35D44R	PRILOCAINE	721-50-6	PRILOCAINE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197877	lidocaine 2.5 % / prilocaine 2.5 % Topical Cream	PSN	c05f3803-92ae-42b7-8248-933bd92d6116	3
197877	lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical Cream	SCD	c05f3803-92ae-42b7-8248-933bd92d6116	3
197877	lidocaine 2.5 % / prilocaine 2.5 % Topical Cream	SY	c05f3803-92ae-42b7-8248-933bd92d6116	3

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-443-30	61919044330	5 g in 1 TUBE (61919-443-30)	5 g	2015-01-01	0000-00-00	No	No	Current