Australian Gold
- Product NDC
- 58443-0387
- 11-digit product format
- 584430387
- Labeler code
- 58443
- Product ID
- 58443-0387_b8a6622d-9ec1-0255-e053-2995a90ae431
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate, Octocrylene
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- Prime Enterprises, Inc.
- Application
- part352
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2020-03-02
- Marketing end
- 0000-00-00
- Substance
- HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
- Active strength
- 92 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 |
|---|---|---|---|---|---|---|---|---|
| 58443-0387-2 | 58443038702 | 15.27 mL in 1 CANISTER (58443-0387-2) | 15.27 ml | 2020-03-02 | 0000-00-00 | No | No | Current |