Australian Gold

Product NDC
58443-0279
11-digit product format
584430279
Labeler code
58443
Product ID
58443-0279_b8b8fb0c-75d7-2a5b-e053-2995a90af9c4
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
2019-10-31
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength
9 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
58443-0279-458443027904237 mL in 1 BOTTLE (58443-0279-4) 237 ml2019-10-310000-00-00NoNoCurrent