LIDOCAINE AND PRILOCAINE

Product NDC: 71335-2970
11-digit product format: 713352970
Labeler code: 71335
Product ID: 71335-2970_f0661ee2-452d-433c-9452-bb728b9e7b7a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine and Prilocaine
Dosage form: CREAM
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA212482
Marketing category: ANDA
Marketing start: 2022-12-20
Substance: LIDOCAINE; PRILOCAINE
Active strength: 25; 25 mg/g; mg/g
Pharmacologic classes: Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-2970_f0661ee2-452d-433c-9452-bb728b9e7b7a
SPL ID: f0661ee2-452d-433c-9452-bb728b9e7b7a
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: LIDOCAINE AND PRILOCAINE
Generic name: Lidocaine and Prilocaine
Dosage form: CREAM
Route: TOPICAL
Marketing start: 2022-12-20
Marketing category: ANDA
Application number: ANDA212482
Pharmacologic classes: Amide Local Anesthetic [EPC]; Amides [CS]; Antiarrhythmic [EPC]; Local Anesthesia [PE]
Listing expiration: 2026-12-31

Ingredient	Strength
LIDOCAINE	25 mg/g
PRILOCAINE	25 mg/g

Package NDC	Description	Marketing start	Sample
71335-2970-1	1 TUBE in 1 CARTON (71335-2970-1) / 30 g in 1 TUBE	2025-10-21	No

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

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2970-1	71335297001	1 TUBE in 1 CARTON (71335-2970-1) / 30 g in 1 TUBE	1 tube	2025-10-21	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
Lidocaine and Prilocaine Cream, USP 2.5%/2.5%	Bryant Ranch Prepack	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	100