Australian Gold
- Product NDC
- 58443-0270
- 11-digit product format
- 584430270
- Labeler code
- 58443
- Product ID
- 58443-0270_b8b6216d-f913-1893-e053-2a95a90a73a5
- 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
- 2019-10-31
- Marketing end
- 0000-00-00
- Substance
- OCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE
- Active strength
- 51 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 |
|---|---|---|---|---|---|---|---|---|
| 58443-0270-4 | 58443027004 | 237 mL in 1 TUBE (58443-0270-4) | 237 ml | 2019-10-31 | 0000-00-00 | No | No | Current |