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 |
|---|---|---|---|---|---|---|
| Bisacodyl | BISACODYL SUPPOSITORIES | Oncor Pharmaceuticals | 6f0aefc9-cd5f-4bdd-89c2-b6a80558987c | 2025-01-24 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | NuCare Pharmaceuticals, Inc. | 2c65319f-6cf5-aa90-e063-6394a90ad662 | 2025-01-23 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Cardinal Health (Leader) 70000 | cde87f95-73c0-46f5-9349-37e04096048c | 2025-01-22 | Warnings | M007 |
| Senna-Tabs | SENNA 8.6MG | Ulai Health LLC | 485129a0-8340-4f61-be51-5abff5032b8d | 2025-01-20 | Warnings | M007 |
| Fiber Laxative | CALCIUM POLYCARBOPHIL | Topco Associates, LLC | 0609468d-ee66-49af-be40-e51965b88f6f | 2025-01-20 | Warnings | M007 |
| Soluble Fiber | METHYLCELLULOSE | United Natural Foods, Inc. dba UNFI | 6decd5ef-e8e1-44ae-8465-6266cf18e81e | 2025-01-20 | Warnings | M007 |
| Perdiem | SENNOSIDES, STIMULANT LAXATIVE | Haleon US Holdings LLC | 6b256c8f-3953-4c69-9a16-ffa0511bdbcd | 2025-01-16 | Warnings | M007 |
| Senna Syrup | SENNOSIDES | Everpharm LLC | 0ea9f2b5-4533-4b71-b019-10ecb3c06459 | 2025-01-16 | Warnings | M007 |
| Anecream 5 | LIDOCAINE 5% | Focus Health Group | 1810edc3-093e-402f-bcb0-9c731da283a7 | 2025-01-15 | Warnings | M007 |
| Senna | SENNOSIDES | Reliable 1 Laboratories LLC | ae46a611-20f2-74c8-e053-2995a90a32ce | 2025-01-15 | Warnings | M007 |
| Sennosides and Docusate Sodium | SENNOSIDES, DOCUSATE SODIUM | Reliable-1 Laboratories LLC | a97a1829-f62f-2014-e053-2a95a90a8cc5 | 2025-01-15 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | NCS HealthCare of KY, LLC dba Vangard Labs | 4d678da0-9ada-4d00-9db9-33b45c776107 | 2025-01-15 | Warnings | M007 |
| Goodsense Fiber laxative 147 | CALCIUM POLYCARBOPHIL | GoodSense | 17f5570b-be85-9dce-e063-6294a90abeaf | 2025-01-14 | Warnings | M007 |
| Sunmark Mineral Oil Laxative | MINERAL OIL | Strategic Sourcing Services | c54f7df2-3845-425f-b13e-3dc000123f3c | 2025-01-14 | Warnings | M007 |
| Senna-S | SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG | Ulai Health LLC | c0e27b02-8ef2-4239-8f8c-790f7d978dc0 | 2025-01-12 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Major Pharmaceuticals | 1541ff5b-11f8-444b-a2a0-8e3086ae650a | 2025-01-10 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | AvPAK | f31a4349-7826-45c0-9388-6b938d167b7a | 2025-01-09 | Warnings | M007 |
| Docusate sodium | DOCUSATE SODIUM | APNAR PHARMA LP | 05b0732b-012f-78ee-e063-6294a90a839a | 2025-01-09 | Warnings | M007 |
| Foster and Thrive Ready to Use Saline Laxative | SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | McKesson | e5fdfcfd-5340-4929-9f68-2696110cca8e | 2025-01-07 | Warnings | M007 |
| Calcium Polycarbophil | CALCIUM POLYCARBOPHIL | SHANDONG XINHUA PHARMACEUTICAL CO., LTD. | ee06868b-f741-8da2-e053-2a95a90a9772 | 2025-01-02 | 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 |