Austalian Gold

Product NDC
58443-0311
11-digit product format
584430311
Labeler code
58443
Product ID
58443-0311_a5019be3-5206-7c8e-e053-2995a90a131f
Type
HUMAN OTC DRUG
Nonproprietary name
Octisalate, Avobenzone, 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; AVOBENZONE; OCTISALATE
Active strength
19 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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
58443-0311-458443031104237 mL in 1 BOTTLE, SPRAY (58443-0311-4) 237 ml2019-10-080000-00-00NoNoCurrent