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 |
|---|---|---|---|---|---|---|
| Stratuscare Glycerin Laxative Pediatric | GLYCERIN | Stratus Pharmaceuticals | 6ae6d3c4-bb3b-4436-b76d-8654bf871e66 | 2024-11-01 | Warnings | M007 |
| Rite Aid Fiber Therapy | METHYLCELLULOSE | RITE AID CORPORATION | e50cea80-c020-4b85-b61f-d053f11f479b | 2024-10-30 | Warnings | M007 |
| Rite Aid Fiber Caplets | CALCIUM POLYCARBOPHIL | RITE AID CORPORATION | 06e46cb0-2928-479e-984d-2305fff995e0 | 2024-10-30 | Warnings | M007 |
| Premier Value Orange Flavor | PSYLLIUM HUSK | PHARMACY VALUE ALLIANCE, LLC | 2d580965-2bef-46ee-8532-fbe34330a4b4 | 2024-10-28 | Warnings | M007 |
| Premier Value Fiber Therapy | METHYLCELLULOSE | PHARMACY VALUE ALLIANCE, LLC | b875d5f8-02f3-4474-9fda-83091bc7de04 | 2024-10-28 | Warnings | M007 |
| Premier Value Fiber Therapy Original Coarse | PSYLLIUM HUSK | PHARMACY VALUE ALLIANCE, LLC | 8c85a13d-ae99-4599-9a28-c3965caa6376 | 2024-10-28 | Warnings | M007 |
| Premier Value | CALCIUM POLYCARBOPHIL | PHARMACY VALUE ALLIANCE, LLC | 4d766548-00d0-41bd-bb58-b69e037c77e2 | 2024-10-28 | Warnings | M007 |
| Premier Value Fiber | PSYLLIUM HUSK | Chain Drug Consortium, LLC | c507fe4a-1f8e-4780-a2f5-9da6e5922bef | 2024-10-28 | Warnings | M007 |
| Premier Value Fiber Therapy Orange Flavor | PSYLLIUM HUSK | PHARMACY VALUE ALLIANCE, LLC | 85651bd7-e959-4455-a5ed-bd0223ce0563 | 2024-10-28 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM AND SENNOSIDES | BETTER LIVING BRANDS LLC. | f2c61c71-9a23-4bd3-e053-2a95a90ad460 | 2024-10-26 | Warnings | M007 |
| Pedia-Lax | GLYCERIN | C.B. Fleet Company, Inc. | ae367381-7146-4307-823d-2bb44c1d4200 | 2024-10-25 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Target Corporation | f7309f4a-f1f5-420e-bfc7-fb4495a5afba | 2024-10-24 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Target Corporation | 2540ae39-2218-0f6a-e063-6294a90a5efc | 2024-10-24 | Warnings | M007 |
| DOCUSATE SODIUM | DOCUSATE SODIUM | Sam's West Inc | b0e99ebb-41fc-459f-86d2-f0e3527f97b0 | 2024-10-24 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | A-S Medication Solutions | ef05ad45-7082-43e6-9533-a79c5aa0f373 | 2024-10-22 | Warnings | M007 |
| Bliss GVS Children | GLYCERIN | Bliss GVS Pharma Limited | 03237ed2-265f-4acd-b504-d82b9263287c | 2024-10-17 | Warnings | M007 |
| NATURAL Epsom Salt | MAGNESIUM SULFATE | Universal Distribution Center LLC | b2682e51-ffa4-4556-b2a6-b0dbd543fd4f | 2024-10-16 | Warnings | M007 |
| Bliss GVS | GLYCERIN | Bliss GVS Pharma Limited | 1a3982a1-9ce9-4a1a-ba73-ebe2d8647109 | 2024-10-10 | Warnings | M007 |
| Bisacodyl | BISACODYL | Padagis US LLC | 7eada0fc-5f83-43da-a56f-b0f537298208 | 2024-10-10 | Warnings | M007 |
| exchange select stool softener | DOCUSATE SODIUM | Army & Air Force Exchange Service | 14985848-d791-42b9-ad7e-810a85bb1ee1 | 2024-10-07 | 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 |