Stool Softener Laxative
- Product NDC
- 63868-946
- 11-digit product format
- 638680946
- Labeler code
- 63868
- Product ID
- 63868-946_866fb276-b4fd-4634-b66e-38a6b29bb980
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- docusate sodium and sennosides
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- QUALITY CHOICE (Chain Drug Marketing Association)
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-03-31
- Substance
- DOCUSATE SODIUM; SENNOSIDES
- Active strength
- 50; 8.6 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- Stool Softener Laxative
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOCUSATE SODIUM | 50 mg/1 |
| SENNOSIDES | 8.6 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F05Q2T2JA0 | Internal UNII lookup |
| 3FYP5M0IJX | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 998740 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 72f8e8d7-ee38-4bd3-8711-f11fded0cede | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63868-946-01 | Stool Softener Laxative | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63868-946 | STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240502_72f8e8d7-ee38-4bd3-8711-f11fded0cede.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 |
|---|---|---|---|---|---|---|
| Freskaro Castor Oil | CASTOR OIL | Pharma Nobis, LLC | fbd6bdd5-a7a1-3f28-e053-6294a90aab87 | 2023-12-28 | Warnings | M007 |
| Humco Castor Oil | CASTOR OIL | Pharma Nobis, LLC | e42f9d37-1b07-177a-e053-2a95a90a9b06 | 2023-12-26 | Warnings | M007 |
| Magnesium Citrate | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Pharma Nobis, LLC | f0477328-eca1-9043-e053-2995a90aaa3d | 2023-12-22 | Warnings | M007 |
| Magnesium Citrate | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY | Pharma Nobis, LLC | f0489f6f-9e60-7d69-e053-2a95a90a9dfb | 2023-12-22 | Warnings | M007 |
| Magnesium Citrate | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPE | Pharma Nobis, LLC | f0488c86-6c74-3987-e053-2a95a90a31b4 | 2023-12-22 | Warnings | M007 |
| Mineral Oil Heavy | MINERAL OIL | Pharma Nobis, LLC | e42f6c6d-c4de-02c6-e053-2995a90a3ace | 2023-12-22 | Warnings | M007 |
| Quality Choice Castor Oil | CASTOR OIL | Chain Drug Market Asociation | 18d7124f-7745-45b2-adc4-cb1103add5d6 | 2023-12-20 | Warnings | M007 |
| Premiere Value Castor Oil | CASTOR OIL | Chain Drug Consortium | 5c8c1564-fcff-894b-e053-2991aa0a9c0b | 2023-12-20 | Warnings | M007 |
| Magnesium Citrate | BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRY | Bionpharma, Inc. | f0fa4b72-50a5-5c42-e053-2995a90a159a | 2023-12-20 | Warnings | M007 |
| Harris Teeter Castor Oil | CASTOR OIL | Harris Teeter, LLC | 5cca6b4b-d88f-1c7d-e053-2991aa0a051f | 2023-12-20 | Warnings | M007 |
| Magnesium Citrate | BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Bionpharma, Inc. | f0f9c36e-c43b-05d2-e053-2995a90a6d65 | 2023-12-20 | Warnings | M007 |
| Magnesium Citrate | BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPE | Bionpharma, Inc. | f0f9ff19-ae08-0af0-e053-2a95a90ab842 | 2023-12-20 | Warnings | M007 |
| CVS Mineral Oil | MINERAL OIL | CVS | 9d7402e1-524b-1084-e053-2a95a90ae3af | 2023-12-20 | Warnings | M007 |
| Top Care Castor Oil | CASTOR OIL | TOPCO ASSOCIATES LLC | 8dce1a1f-e765-9c75-e053-2995a90abf9f | 2023-12-18 | Warnings | M007 |
| Humco Epson Salt | MAGNESIUM SULFATE | Humco Holding Group, Inc. | 7a9d1b77-6c39-46f1-86f2-4059dde20f85 | 2023-12-15 | Warnings | M007 |
| Humco Mineral Oil Heavy | MINERAL OIL | Humco Holding Group, Inc. | 9f943fdf-5058-4e18-ba96-6be112bf72ca | 2023-12-15 | Warnings | M007 |
| Rite Aid Castor Oil | CASTOR OIL | Rite Aid Corporation. | 5e0d3664-b01b-ba28-e053-2991aa0a8a4c | 2023-12-15 | Warnings | M007 |
| GNP Castor Oil | CASTOR OIL | Amerisource Bergen | 5d06bec6-f1e7-4f0c-e053-2991aa0a8ad8 | 2023-12-14 | Warnings | M007 |
| Sankaijo | DOCUSATE SODIUM, SENNOSIDES | Sato Pharmaceutical Co., Ltd. | 83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b | 2023-11-29 | Warnings | M007 |
| SIMPEX Bisacodyl laxative | BISACODYL | Simpex Pharma Pvt. Ltd | 5114ed64-4fec-401b-8a91-8df3e42b10b1 | 2023-11-29 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 998740 | sennosides 8.6 MG / docusate sodium 50 MG Oral Tablet | PSN | 72f8e8d7-ee38-4bd3-8711-f11fded0cede | 5 |
| 998740 | docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet | SCD | 72f8e8d7-ee38-4bd3-8711-f11fded0cede | 5 |
| 998740 | DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet | SY | 72f8e8d7-ee38-4bd3-8711-f11fded0cede | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63868-946-01 | 63868094601 | 100 TABLET in 1 BOTTLE, PLASTIC (63868-946-01) | 100 tablet | 2021-03-31 | 0000-00-00 | No | No | Current |