Stool Softener Laxative
- Product NDC
- 49035-584
- Requested package NDC
- 49035-584-25
- 11-digit product format
- 490350584
- Labeler code
- 49035
- Product ID
- 49035-584_786ad1ac-0c46-4f74-afad-3d3958c34440
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docusate Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
- Application
- part334
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2018-01-31
- Marketing end
- 2025-01-31
- Substance
- DOCUSATE SODIUM
- Active strength
- 100 mg/1
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 package | package | 49035-584 | 49035-584-25 | D | Discontinued by firm | 2026-10-16 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
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 |
|---|---|---|---|---|---|---|---|
| 49035-584-25 | 49035058425 | 1 BOTTLE, PLASTIC in 1 BOX (49035-584-25) > 25 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2018-01-31 | 2025-01-31 | No | No | Current |