Australian Gold

Product NDC
58443-0075
11-digit product format
584430075
Labeler code
58443
Product ID
58443-0075_e1e8458d-4524-0d14-e053-2995a90a3c2b
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octocrylene and Oxybenzone
Dosage form
GEL
Route
TOPICAL
Labeler
Prime Enterprises, Inc.
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-11-11
Marketing end
2022-06-30
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
8 mg/mL; mg/mL; mg/mL; 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
58443-0075-458443007504237 mL in 1 BOTTLE (58443-0075-4) 237 ml2013-11-110000-00-00NoNoCurrent