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 |
|---|---|---|---|---|---|---|
| Docusate Sodium Oral Liquid | DOCUSATE SODIUM ORAL LIQUID | Kesin Pharma Corporation | 331277b8-8304-d082-e063-6394a90a4dd3 | 2025-04-18 | Warnings | M007 |
| Mineral Oil | MINERAL OIL | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 581f81a0-7488-4c90-b33e-06c6301a4fd2 | 2025-04-17 | Warnings | M007 |
| Vegetable Laxative | SENNOSIDES | Walmart Inc. | 26dc60e7-5a05-64c3-e063-6394a90a55ce | 2025-04-14 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Strategic Sourcing Services LLC | 99aa30ed-9659-4f60-a31d-6aaf09909b51 | 2025-04-14 | Warnings | M007 |
| Fiber Laxative | CALCIUM POLYCARBOPHIL | Geri-Care Pharmaceutical Corp | 616b4399-7626-5e59-e053-2a91aa0a0f75 | 2025-04-07 | Warnings | M007 |
| Calcium Polycarbophil | CALCIUM POLYCARBOPHIL | CITRAGEN PHARMACEUTICALS, INC. | b23dd90f-ba5a-80fc-e053-2995a90a2286 | 2025-04-03 | Warnings | M007 |
| Phillips Milk Of Magnesia Wild Cherry | PHILLIPS MILK OF MAGNESIA WILD CHERRY | Bayer HealthCare LLC. | 0a6d824a-3d9a-07f9-e054-00144ff8d46c | 2025-04-01 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | CVS PHARMACY | 30ce5cbd-cc7a-0b2d-e063-6394a90a8520 | 2025-03-20 | Warnings | M007 |
| Senna | SENNOSIDES | AARNA USA INC. | 7ad21fb7-20eb-48d6-be15-450aa2ec97d3 | 2025-03-20 | Warnings | M007 |
| CVS Health Stool Softener Plus stimulant laxative Softgel | DOCUSATE SODIUM, SENNOSIDES | CVS Pharmacy, Inc | 2881d83d-9929-677a-e063-6394a90a0424 | 2025-03-19 | Warnings | M007 |
| Mineral Oil | MINERAL OIL | Kesin Pharma Corporation | 30a11cc9-e407-23b7-e063-6294a90a7d6e | 2025-03-18 | Warnings | M007 |
| CVS Magnesium Hydroxide Laxative Chew | MAGNESIUM HYDROXIDE | CVS | 30126c74-6f5c-72f3-e063-6394a90ad81f | 2025-03-11 | Warnings | M007 |
| Epsom Salt | EPSOM SALT | Good Sense (Geiss, Destin & Dunn, Inc.) | c7a9f180-9c73-4317-adbe-f95702fb4802 | 2025-03-03 | Warnings | M007 |
| Magnesium Citrate Saline Laxative | MAGNESIUM CITRATE | AARNA USA INC. | e7550220-df26-4a7a-a254-bebb225d9e5e | 2025-03-01 | Warnings | M007 |
| Fiber laxative | CALCIUM POLYCARBOPHIL | Discount Drug Mart, Inc | 2e0c4736-3d27-e088-e063-6294a90aeca8 | 2025-02-27 | Warnings | M007 |
| Mineral oil | MINERAL OIL | P & L Development, LLC | 68e88119-1468-4ab7-a5fa-242d960d25df | 2025-02-21 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Whole Foods Market | 5a88048e-5417-4d8e-a149-f51610a5d420 | 2025-02-19 | Warnings | M007 |
| Sennosides | SENNOSIDES | PD-Rx Pharmaceuticals, Inc. | 829d24b7-a46a-4a29-88fe-180f35a2b6cd | 2025-02-18 | Warnings | M007 |
| Stool Softener and Stimulant Laxative | DOCUSATE SODIUM, SENNOSIDES | H-E-B | c19280c2-f968-b582-e053-2995a90a9bd3 | 2025-02-14 | Warnings | M007 |
| STOOL SOFTENER-STIMULANT LAXATIVE | STOOL SOFTENER-STIMULANT LAXATIVE | Kroger Company | a22c9f95-e3a9-bfd3-e053-2995a90a3c66 | 2025-02-13 | 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 |