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 |
|---|---|---|---|---|---|---|
| Stool Softener | DOCUSATE SODIUM | Bryant Ranch Prepack | 2c9a1fe7-b77b-436b-8701-9f95f642d001 | 2024-07-05 | Warnings | M007 |
| SENNA | SENNA | Precision Dose, Inc. | e637777e-a39d-4e2f-a95c-4f524aa122f7 | 2024-07-05 | Warnings | M007 |
| Gentle Laxative | MAGNESIUM HYDROXIDE | GERI-CARE PHARMACEUTICALS, CORP | 1c462af8-af1a-391c-e063-6394a90a8b49 | 2024-07-02 | Warnings | M007 |
| Good Neighbor Pharmacy Fiber-Caps Fiber Laxative Stimulant Free | CALCIUM POLYCARBOPHIL | Amerisourcebergen Drug Corporation | 4911fb44-e070-46c1-8f90-b78ceb10e51e | 2024-06-28 | Warnings | M007 |
| Fleet | DOCUSATE SODIUM | C.B. Fleet Company, Inc. | 56a7b6c5-d674-4eed-91c2-77f7d18fff32 | 2024-06-27 | Warnings | M007 |
| Stool Softener Laxative Extra Strength | DOCUSATE SODIUM | WALMART INC. (see also Equate) | 2cf6c9bf-c318-445d-9306-5675b1d424b0 | 2024-06-26 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | WALMART INC. (see also Equate) | d9db24b5-e3b5-47f9-b86b-bc8d70896a11 | 2024-06-26 | Warnings | M007 |
| Stool Softener | DOCUSATE CALCIUM | Walgreens | 2791223a-7ac0-47e5-9a6a-4d9a02cfeb63 | 2024-06-25 | Warnings | M007 |
| Fleet | BISACODYL | C.B. Fleet Company, Inc. | 4e0d973f-e6dc-48d9-8df3-1d47c87840f1 | 2024-06-21 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | TOP CARE (Topco Associates LLC) | 3b184800-649b-45d0-9586-8055d6d7fe08 | 2024-06-20 | Warnings | M007 |
| Senna Laxative | SENNA LAXATIVE | Good Sense | 9393032e-4343-4ac5-8e91-36013e5ca089 | 2024-06-18 | Warnings | M007 |
| Stool Softener | STOOL SOFTENER | Good Sense | 64266195-1b07-42c2-98a7-d76c12f74776 | 2024-06-18 | Warnings | M007 |
| Stool Softener Plus Stimulant | DOCUSATE SODIUM AND SENNOSIDES | United Natural Foods, Inc. dba UNFI | 6c8c7c46-3ded-4e89-8e16-30eeb72aa08b | 2024-06-14 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | United Natural Foods, Inc. dba UNFI | 50ca1ce2-885f-4b71-a5fb-90c2cf508ce6 | 2024-06-14 | Warnings | M007 |
| basic care stool softener | DOCUSATE SODIUM | Amazon.com Services LLC | 356a889f-ec23-4eb2-a25c-bbe609475155 | 2024-06-14 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | United Natural Foods, Inc. dba UNFI | 88cc2575-27a1-4514-bc41-bd1eac283814 | 2024-06-13 | Warnings | M007 |
| Senna laxative | SENNOSIDES | United Natural Foods, Inc. dba UNFI | 2b5e1f03-0182-4d1c-8ba0-b1008b1335ad | 2024-06-12 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | TARGET Corporation | 1b7edd67-7b14-4fdd-9821-637f4b3c3a2c | 2024-06-06 | Warnings | M007 |
| Senna | SENNOSIDES | Patrin Pharma, Inc. | a9f1ef8d-8700-481f-a709-972bb9d27153 | 2024-05-30 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | WALGREEN COMPANY | 5f9cd233-6c46-5b52-e053-2991aa0ab729 | 2024-05-23 | 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 |