Stool Softener
- Product NDC
- 68016-257
- 11-digit product format
- 680160257
- Labeler code
- 68016
- Product ID
- 68016-257_f06e527b-159b-29d9-e053-2a95a90aab35
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docusate Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- PHARMACY VALUE ALLIANCE, LLC
- Application
- part334
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2022-10-01
- Marketing end
- 0000-00-00
- Substance
- DOCUSATE SODIUM
- Active strength
- 100 mg/1
- 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 | 68016-257 | D | Discontinued by firm | 2026-10-15 | ||
| excluded package | package | 68016-257 | 68016-257-01 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 68016-257 | 68016-257-25 | 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68016-257-25 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68016-257-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68016-257-25 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68016-257-01 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68016-257-01 | 68016025701 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (68016-257-01) | 2022-10-01 | 0000-00-00 | No | No | Current |
| 68016-257-25 | 68016025725 | 250 CAPSULE, LIQUID FILLED in 1 BOTTLE (68016-257-25) | 2022-10-01 | 0000-00-00 | No | No | Current |