Australian Gold

Product NDC
58443-0381
11-digit product format
584430381
Labeler code
58443
Product ID
58443-0381_b83f36ea-4103-2883-e053-2995a90a644f
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Prime Enterprises, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2019-10-08
Marketing end
0000-00-00
Substance
OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
19 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0381-358443038103100 mL in 1 BOTTLE, SPRAY (58443-0381-3) 100 ml2019-10-080000-00-00NoNoCurrent