Australian Gold
- Product NDC
- 58443-0570
- 11-digit product format
- 584430570
- Labeler code
- 58443
- Product ID
- 58443-0570_e819b343-e88f-6161-e053-2a95a90a42b7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Octisalate, Avobenzone, Octocrylene, Homosalate
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- Prime Enterprises Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2021-07-26
- Marketing end
- 0000-00-00
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 30 mg/mL; mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58443-0570-4 | 58443057004 | 237 mL in 1 BOTTLE, SPRAY (58443-0570-4) | 237 ml | 2021-07-26 | 0000-00-00 | No | No | Current |