Stool Softener
- Product NDC
- 85111-401
- 11-digit product format
- 851110401
- Labeler code
- 85111
- Product ID
- 85111-401_44fbb054-2c67-2bdd-e063-6294a90ad938
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docusate Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- RMT HEALTH LLC
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-09-01
- Substance
- DOCUSATE SODIUM
- Active strength
- 100 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Stool Softener
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOCUSATE SODIUM | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F05Q2T2JA0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1115005 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 44fbb197-fe90-c5a8-e063-6394a90adb7d | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85111-401-10 | Stool Softener | 1000 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 1000 | 1 | |
| 85111-401-50 | Stool Softener | 500 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 500 | 1 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NuValu Epsom Salt | MAGNESIUM SULFATE (HEPTAHYDRATE) | J C SALES | 5a503d8d-7899-4b1e-be6f-8e2a759af265 | 2024-12-04 | Warnings | M007 |
| SENNOSIDES | SENNOSIDES | CVS Pharmacy, Inc. | 6dffc3f5-bae0-c436-e053-2991aa0a0f8b | 2024-12-02 | Warnings | M007 |
| Pure and Gentle | MINERAL OIL | Medline Industries, LP | 96d4cad5-0602-4c31-94ed-3117b4fd4a94 | 2024-11-26 | Warnings | M007 |
| Pure and Gentle Laxative | SODIUM PHOSPHATE | Medline Industries, LP | e3165538-75dd-4f0f-adc8-d4075de10f1e | 2024-11-26 | Warnings | M007 |
| DOCUSATE SODIUM 50 MG | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | af7533e6-8b06-48a4-940e-7ecb57b24b59 | 2024-11-25 | Warnings | M007 |
| DOCUSATE SODIUM 100mg Two-Tone | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | a923e5ca-86fd-4bf9-9931-180ddfdeae66 | 2024-11-25 | Warnings | M007 |
| DOCUSATE SODIUM 100mg Two-Tone | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | 7cf1df18-d658-4bff-8a62-365fc5656942 | 2024-11-25 | Warnings | M007 |
| DOCUSATE SODIUM 100mg | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. | c5bdfbfc-d24a-4088-9b60-ecea8120ff43 | 2024-11-25 | Warnings | M007 |
| DOCUSATE SODIUM | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | b10fdf50-289e-41f3-9b83-a4e4dd892f88 | 2024-11-21 | Warnings | M007 |
| DOCUSATE SODIUM 100mg Two-Tone | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 85c64624-428d-46fa-8071-f42b8feec049 | 2024-11-21 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 33251cb7-b7b1-4f6c-9e10-4fa64cbf03a0 | 2024-11-21 | Warnings | M007 |
| STOOL SOFTENER | DOCUSATE SODIUM | Walgreen Co. | d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab5 | 2024-11-21 | Warnings | M007 |
| 4718 Enema, Mineral Oil | 4718 ENEMA, MINERAL OIL | Dynarex | 9e51c852-9477-5cf5-e053-2a95a90a97db | 2024-11-20 | Warnings | M007 |
| Relief | SODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE | Leosons Overseas Corp | 5b301d5b-1e2c-47ed-a05f-d6be0fdfc940 | 2024-11-19 | Warnings | M007 |
| REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Leosons Overseas Corp | 90e7c2b4-35e1-4a27-afea-9257c480e190 | 2024-11-19 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM 100MG | PuraCap Pharmaceutical LLC | 272c86f1-f229-2ebf-e063-6394a90a3471 | 2024-11-18 | Warnings | M007 |
| Milk of Magnesia Concentrate | MAGNESIUM HYDROXIDE | PAI Holdings, LLC dba PAI Pharma | 2a99a1a8-a830-429f-9cfd-3f29c3d3547c | 2024-11-12 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | A-S Medication Solutions | 122486e9-74dd-4181-97d1-0b07688280f4 | 2024-11-06 | Warnings | M007 |
| Stratuscare Adult Glycerin | GLYCERIN | Stratus Pharmaceuticals | 3e1935da-5c1f-4942-98dd-320fade82321 | 2024-11-04 | Warnings | M007 |
| DOCUSATE SODIUM | DOCUSATE SODIUM | NuCare Pharmaceuticals,Inc. | fdf3c8e1-d554-4cdb-e053-6394a90a542e | 2024-11-01 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1115005 | docusate sodium 100 MG Oral Capsule | PSN | 44fbb197-fe90-c5a8-e063-6394a90adb7d | 1 |
| 1115005 | docusate sodium 100 MG Oral Capsule | SCD | 44fbb197-fe90-c5a8-e063-6394a90adb7d | 1 |
| 1115005 | DOSS Sodium 100 MG Oral Capsule | SY | 44fbb197-fe90-c5a8-e063-6394a90adb7d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 85111-401-10 | 85111040110 | 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (85111-401-10) | 2025-09-01 | No | No | Current |
| 85111-401-50 | 85111040150 | 500 CAPSULE, LIQUID FILLED in 1 BOTTLE (85111-401-50) | 2025-09-01 | No | No | Current |