Sky Wellness

Product NDC
58443-0370
11-digit product format
584430370
Labeler code
58443
Product ID
58443-0370_e9a994d7-532a-ae86-e053-2995a90a9a19
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride, Menthol
Dosage form
STICK
Route
TOPICAL
Labeler
Prime Enterprises
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-05-01
Marketing end
2024-12-31
Substance
LIDOCAINE HYDROCHLORIDE; 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
58443-0370-35844303700389 mL in 1 BOTTLE (58443-0370-3) 89 ml2019-05-010000-00-00NoNoCurrent