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 |
|---|---|---|---|---|---|---|
| Topwin Speedy Enema | GLYCERIN | Health Chemical Pharmaceutical Co., Ltd | 3ba8c3d2-1780-42e1-bec5-8f98771d475e | 2026-07-27 | Warnings | M007 |
| Curewell Senna Syrup | SENNOSIDES | RMT HEALTH LLC | 57345324-5140-5cde-e063-6294a90ab97c | 2026-07-22 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE ORAL SOLUTION | WALGREEN COMPANY | 4ffe54ae-3126-ba58-e063-6294a90a8877 | 2026-07-20 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Bryant Ranch Prepack | deca083b-5c72-40fa-9021-b74028426a5a | 2026-07-20 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Cardinal Health 107, LLC | fc5e82b6-e25c-4686-9781-2205819685f5 | 2026-07-20 | Warnings | M007 |
| Best Choice Fiber Therapy Orange Flavor | PSYLLIUM HUSK | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 0b25f6c0-441b-41ef-ab19-2a29705a56c6 | 2026-07-17 | Warnings | M007 |
| Best Choice Fiber Therapy original coarse | PSYLLIUM HUSK | BEST CHOICE (VALU MERCHANDISERS COMPANY) | d7eb71af-17e3-465e-b464-f77b3be7266d | 2026-07-17 | Warnings | M007 |
| Best Choice | CALCIUM POLYCARBOPHIL | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 24eb538f-abcb-4a91-b691-a8aac01c952a | 2026-07-17 | Warnings | M007 |
| Best Choice Fiber Laxative | PSYLLIUM HUSK | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 92b46689-b5fc-41f4-91ac-535699900b39 | 2026-07-17 | Warnings | M007 |
| citroma | MAGNESIUM CITRATE | CVS Pharmacy, Inc. | 498acb19-b2f4-4af0-8996-390115c17fe0 | 2026-07-17 | Warnings, Adverse reactions | M007 |
| Best Choice Fiber Therapy | METHYLCELLULOSE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | fab6567f-d988-43f2-a6cf-44e5b24af279 | 2026-07-17 | Warnings | M007 |
| stool softener | DOCUSATE SODIUM | Amazon.com Services LLC | 4f83953e-3779-43b7-a5c6-7442a0675d9b | 2026-07-16 | Warnings | M007 |
| Stool Softener Extra Strength | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 183576bd-c252-471b-8797-32cac5b0329c | 2026-07-16 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Walgreens | 3f9d54d9-a9d5-40ff-a8a2-431997b58999 | 2026-07-16 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Walgreens | 7174021b-bdc0-4fd3-90e7-3904980033c4 | 2026-07-16 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | STRATEGIC SOURCING SERVICES LLC | ff2179bd-cc76-9ee9-e053-6294a90a01c9 | 2026-07-15 | Warnings | M007 |
| FEVIA Constipation Control | DOCUSATE SODIUM | VIVUNT PHARMA LLC | 4b21ca11-b81f-402c-e063-6394a90a3acb | 2026-07-15 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | STRATEGIC SOURCING SERVICES LLC | 56957a51-7366-f7ed-e063-6294a90abfc5 | 2026-07-14 | Warnings | M007 |
| Laxative | SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 6103fded-622c-4551-9f32-ca1da44683ac | 2026-07-10 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | The Kroger Co. | 800fa966-077d-4624-9e36-75fe8863dad0 | 2026-07-10 | 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 |