Prime

Product NDC
58443-0495
11-digit product format
584430495
Labeler code
58443
Product ID
58443-0495_dbea19e9-4e30-3ac9-e053-2995a90a9c32
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Prime Enterprises
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-02
Marketing end
2022-07-31
Substance
ALCOHOL
Active strength
606 mg/mL
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
58443-0495-9584430495093800 mL in 1 BOTTLE (58443-0495-9) 3800 ml2020-07-020000-00-00NoNoCurrent