DOCUSATE SODIUM 50 MG
- Product NDC
- 53345-015
- 11-digit product format
- 533450015
- Labeler code
- 53345
- Product ID
- 53345-015_27c70a38-225f-2753-e063-6394a90a9560
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DOCUSATE SODIUM
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-11-12
- Substance
- DOCUSATE SODIUM
- Active strength
- 50 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
- DOCUSATE SODIUM 50 MG
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOCUSATE SODIUM | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F05Q2T2JA0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1247759 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| af7533e6-8b06-48a4-940e-7ecb57b24b59 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53345-015-01 | DOCUSATE SODIUM 50 MG | 20000 in 1 BAG | CAPSULE, LIQUID FILLED | 20000 | 3 | |
| 53345-015-01 | DOCUSATE SODIUM 50 MG | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53345-015 | DOCUSATE SODIUM 50 MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241127_af7533e6-8b06-48a4-940e-7ecb57b24b59.zip |
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 |
|---|---|---|---|---|---|---|
| Epsom Salt | MAGNESIUM SULFATE | Sam's West, Inc | 6edb7688-0a64-4a7e-a0c0-9f75c96682fe | 2026-02-03 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | cb2698b1-6c58-417f-ae86-74fbe3814626 | 2026-02-03 | Warnings | M007 |
| Castor Oil | CASTOR OIL | CVS Pharmacy, Inc. | f20de8f2-3637-4485-8b80-0a12fd5e651c | 2026-02-02 | Warnings, Adverse reactions | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | CVS Pharmacy, Inc. | 1dca8f4a-f544-4ae5-bb0a-8b671d4a488a | 2026-02-02 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | CVS Pharmacy, Inc. | 15a9996d-7391-41f8-ab15-27ee2a6a60e4 | 2026-02-02 | Warnings, Adverse reactions | M007 |
| citroma | MAGESIUM CITRATE | Rite Aid Corporation | e562bf42-b9e1-4ea8-b880-7bec4dd620b4 | 2026-01-30 | Warnings, Adverse reactions | M007 |
| SENNA-S | DOCUSATE SODIUM AND SENNOSIDES | Strategic Sourcing Services, LLC | 905bd658-a0af-4f20-be3d-00c54868a26c | 2026-01-29 | Warnings | M007 |
| Senna Laxative | SENNOSIDES | Strategic Sourcing Services LLC | 9248a907-a8bd-47d5-98a2-48534d6023d4 | 2026-01-29 | Warnings | M007 |
| Leader Castor Oil | CASTOR OIL | Cardinal Health, 110 dba Leader | 49e3a40a-b717-43f6-abed-473d7ed03c2e | 2026-01-29 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | CARDINAL HEALTH 110, LLC. DBA LEADER | 803f444f-d136-4f06-9842-24a71a3d7d6b | 2026-01-29 | Warnings, Adverse reactions | M007 |
| Equate Ready-to-Use Enema Laxative | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | WalMart | 04c7440e-5b25-4b63-9604-321298d51021 | 2026-01-29 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Meijer Distribution Inc. | 81edf0d8-b6f3-4b3a-85db-0108160756b1 | 2026-01-28 | Warnings | M007 |
| Quality Choice Laxative | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | Chain Drug Marketing Association | 1cac3b6b-155b-47bb-bb79-17c55d345736 | 2026-01-28 | Warnings | M007 |
| Docusate Sodium and Sennosides | DOCUSATE SODIUM AND SENNOSIDES | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1ad73079-ebb3-dae7-e063-6294a90a0558 | 2026-01-28 | Warnings | M007 |
| DOCUSATE SODIUM 100MG | DOCUSATE SODIUM 100MG | Farmacias De Similares TX LLC | 44269b79-a5ad-f443-e063-6294a90a8473 | 2026-01-28 | Warnings | M007 |
| Docusate Sodium and Sennosides | DOCUSATE SODIUM AND SENNOSIDES | SOFTGEL HEALTHCARE PRIVATE LIMITED | 19830f9a-27b1-910d-e063-6294a90adace | 2026-01-27 | Warnings | M007 |
| Sennosides | SENNOSIDES | SOFTGEL HEALTHCARE PRIVATE LIMITED | 94936bd4-8bbf-6211-e053-2995a90a2138 | 2026-01-27 | M007 | |
| Sennosides | SENNOSIDES | Softgel Healthcare Pvt Ltd | 16582306-7321-6c7c-e063-6394a90a509e | 2026-01-27 | Warnings | M007 |
| Vegetable Laxative | SENNOSIDES | Wal-Mart Stores Inc | 97695092-1ded-4723-a015-fdadd7c28c81 | 2026-01-27 | Warnings | M007 |
| Calcium Polycarbophil | CALCIUM POLYCARBOPHIL | CVS Pharmacy, Inc | c3de1c1b-5042-aec3-e053-2a95a90ad134 | 2026-01-27 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1247759 | docusate sodium 50 MG Oral Capsule | PSN | af7533e6-8b06-48a4-940e-7ecb57b24b59 | 3 |
| 1247759 | docusate sodium 50 MG Oral Capsule | SCD | af7533e6-8b06-48a4-940e-7ecb57b24b59 | 3 |
| 1247759 | DOSS Sodium 50 MG Oral Capsule | SY | af7533e6-8b06-48a4-940e-7ecb57b24b59 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53345-015-01 | 53345001501 | 1 BAG in 1 BOX (53345-015-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2013-11-12 | 0000-00-00 | No | No | Current |