LIDOCAINE AND PRILOCAINE

Product NDC
71335-2716
11-digit product format
713352716
Labeler code
71335
Product ID
71335-2716_9999a9e9-508d-4baf-9909-55cd4e1d0632
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
71335-2716_9999a9e9-508d-4baf-9909-55cd4e1d0632
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

Related Records

openFDA Active Ingredients

IngredientStrength
LIDOCAINE25 mg/g
PRILOCAINE25 mg/g

openFDA Harmonized Identifiers

FieldValues
Unii98PI200987, 046O35D44R
Rxcui197877
Spl Set Id5bee9fab-a493-448e-b68c-fb58156d49b6
Manufacturer NameBryant Ranch Prepack

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
98PI200987LIDOCAINE137-58-6LIDOCAINE
046O35D44RPRILOCAINE721-50-6PRILOCAINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2716-1713352716011 TUBE in 1 CARTON (71335-2716-1) / 30 g in 1 TUBE1 tube2025-07-28NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Lidocaine and Prilocaine Cream, USP 2.5%/2.5%Bryant Ranch Prepack2025-07-28HUMAN PRESCRIPTION DRUG LABEL100