Premier Value
- Product NDC
- 68016-831
- 11-digit product format
- 680160831
- Labeler code
- 68016
- Product ID
- 68016-831_81a66df0-7a28-4849-bea9-9624e409fdb5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Mineral
- Dosage form
- OIL
- Route
- ORAL
- Labeler
- Pharmacy Value Alliance LLC
- Application
- part334
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2009-05-19
- Marketing end
- 0000-00-00
- Substance
- MINERAL OIL
- Active strength
- 999 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 68016-831 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 68016-831 | 68016-831-43 | D | Discontinued by firm | 2026-10-15 |
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.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | 68016-831 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | ||
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68016-831 | 68016-831-43 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68016-831-43 | 68016083143 | 473 mL in 1 BOTTLE, PLASTIC (68016-831-43) | 473 ml | 2009-05-19 | 0000-00-00 | No | No | Current |