Austalian Gold
- Product NDC
- 58443-0317
- Requested package NDC
- 58443-0317-3
- 11-digit product format
- 584430317
- Labeler code
- 58443
- Product ID
- 58443-0317_ca7950f9-0e6a-5014-e053-2995a90a5cc0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Prime Enterprises Inc.
- Application
- part352
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2020-12-01
- Marketing end
- 0000-00-00
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 44 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 |
|---|---|---|---|---|---|---|---|---|
| 58443-0317-3 | 58443031703 | 89 mL in 1 BOTTLE (58443-0317-3) | 89 ml | 2020-12-05 | 0000-00-00 | No | No | Current |