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 |
|---|---|---|---|---|---|---|
| Senna-S | SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG | Proficient Rx LP | 8678a3ee-0e2c-4c95-ad2e-83aa601f3238 | 2024-10-01 | Warnings | M007 |
| Pedia-Lax | DOCUSATE SODIUM | C.B. Fleet Company, Inc. | 0e908bea-ebab-44e7-919c-90002e6f5d42 | 2024-10-01 | Warnings | M007 |
| Natural Vegetable Laxative and Stool Softener | DOCUSATE SODIUM AND SENNOSIDES | BETTER LIVING BRANDS LLC. | f2c562e1-4080-44cb-e053-2a95a90a4222 | 2024-09-25 | Warnings | M007 |
| SENNA-S LAXATIVE WITH STOOL SOFTENER | SENNOSIDES | Basic Drugs, Inc. | d32b9956-fc04-8d64-e053-2a95a90a17b3 | 2024-09-14 | Warnings | M007 |
| DOCUSATE SODIUM, EXTRA STRENGTH 250 MG | DOCUSATE SODIUM | Advanced Rx LLC | e8be12c5-c591-eadd-e053-2a95a90a431b | 2024-09-13 | Warnings | M007 |
| Senna | SENNOSIDES | Proficient Rx LP | 5f7f0df4-dabe-4c8f-a2b5-766f20af2f46 | 2024-09-01 | Warnings | M007 |
| Fiber caplets 147 | CALCIUM POLYCARBOPHIL | Chain Drug Marketing Association Inc. | 17e2a50d-1867-49fe-e063-6394a90a56df | 2024-08-27 | Warnings | M007 |
| MAXIMUM STRENGTH LAXATIVE PILLS | SENNOSIDES | TARGET CORPORATION | 7cae52ae-931c-3e7c-e053-2991aa0a8396 | 2024-08-22 | Warnings | M007 |
| STOOL SOFTENER AND STIMULANT LAXATIVE | DOCUSATE SODIUM AND SENNOSIDES | TARGET CORPORATION | 7cac99da-8d89-0aee-e053-2991aa0a0fd9 | 2024-08-22 | Warnings | M007 |
| SENNA LAXATIVE | SENNOSIDES 8.6 MG | TARGET CORPORATION | 7cab058f-3647-7124-e053-2a91aa0a41bd | 2024-08-22 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Padagis Israel Pharmaceuticals Ltd | bce3b245-ec47-4e62-9cad-bb12d0812c18 | 2024-08-15 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | NuCare Pharmaceuticals,Inc. | 56f7966a-c95e-3ce3-e054-00144ff88e88 | 2024-08-14 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Proficient Rx LP | ccfa095c-77f0-41ff-84f8-e02d983c7c74 | 2024-08-01 | Warnings | M007 |
| Magnesium Citrate | HARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Harris Teeter, LLC | 1e8e01fc-2c89-9722-e063-6394a90a6acf | 2024-07-31 | Warnings | M007 |
| Senna laxative | SENNOSIDES | Best Choice (Valu Merchandisers Company) | d5f90aa1-78e5-491f-b09d-399d54f3def1 | 2024-07-31 | Warnings | M007 |
| Stool Softener Laxative Plus Stimulant | DOCUSATE SODIUM AND SENNOSIDES | Walgreens | db528659-768a-46e0-a340-9fbcdb25ea5e | 2024-07-25 | Warnings | M007 |
| Senna laxative | SENNOSIDES | Walgreens | bfa089a6-4767-45e0-b663-ee7e8949d9a4 | 2024-07-25 | Warnings | M007 |
| Dr. Fibra | PSYLLIUM HUSK | Pharmadel LLC | 1a6151c9-e1c4-f0c1-e063-6394a90aad24 | 2024-07-22 | Warnings | M007 |
| BISACODYL | BISCODYL | TARGET CORPORATION | 8ed281d5-b17e-e3bb-e053-2995a90a2590 | 2024-07-15 | Warnings | M007 |
| Stool Softener | DOCUSATE CALCIUM | Walgreens | b6f0770e-671d-4965-9275-b1c224d7f06a | 2024-07-10 | 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 |