Performance Brands Steel Releaf

Product NDC
58443-0268
11-digit product format
584430268
Labeler code
58443
Product ID
58443-0268_e9b8a309-86f9-852d-e053-2a95a90add1a
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride, Menthol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Prime Enterprises, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-07-02
Marketing end
2024-10-31
Substance
LIDOCAINE; MENTHOL
Active strength
38 mg/mL; mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0268-35844302680389 mL in 1 BOTTLE (58443-0268-3) 89 ml2019-07-020000-00-00NoNoCurrent