Australian Gold

Product NDC
58443-0042
11-digit product format
584430042
Labeler code
58443
Product ID
58443-0042_9c58b452-ae88-55c6-e053-2995a90afec2
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Prime Enterprises, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-12-15
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
31 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58443-0042-458443004204237 mL in 1 BOTTLE (58443-0042-4) 237 ml2013-12-150000-00-00NoNoCurrent