Australian Gold
- Product NDC
- 58443-0377
- 11-digit product format
- 584430377
- Labeler code
- 58443
- Product ID
- 58443-0377_b594757c-7855-f918-e053-2995a90a1277
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate, Octocrylene
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Prime Enterprises, Inc.
- Application
- part352
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2020-12-17
- Marketing end
- 0000-00-00
- Substance
- OCTISALATE; OCTOCRYLENE; AVOBENZONE; HOMOSALATE
- Active strength
- 49 mg/mL; 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58443-0377-3 | 58443037703 | 88 mL in 1 TUBE (58443-0377-3) | 88 ml | 2020-12-17 | 0000-00-00 | No | No | Current |