Austalian Gold
- Product NDC
- 58443-0312
- 11-digit product format
- 584430312
- Labeler code
- 58443
- Product ID
- 58443-0312_a5107610-4caf-261c-e053-2a95a90a937f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Octisalate, Avobenzone, Octocrylene, Homosalate
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- Prime Enterprises Inc.
- Application
- part352
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2019-10-30
- Marketing end
- 0000-00-00
- Substance
- OCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE
- Active strength
- 49 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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58443-0312-4 | 58443031204 | 237 mL in 1 BOTTLE, SPRAY (58443-0312-4) | 237 ml | 2019-10-30 | 0000-00-00 | No | No | Current |