- Product NDC
- 58443-0189
- 11-digit product format
- 584430189
- Labeler code
- 58443
- Product ID
- 58443-0189_9c5ae6c8-2f98-858b-e053-2995a90a53f5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- avobenzone, homosalate, octisalate, octocrylene, oxybenzone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Prime Enterprises Inc.
- Application
- part352
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2010-08-04
- Marketing end
- 0000-00-00
- Substance
- OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 19 mg/mL; 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
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 58443-0189 | | I | Inactivated by FDA | | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 58443-0189 | 58443-0189-3 | I | Inactivated by FDA | | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… |