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 |
|---|---|---|---|---|---|---|
| Stool Softener | DOCUSATE SODIUM 100MG | PuraCap Pharmaceutical LLC | 272c86f1-f229-2ebf-e063-6394a90a3471 | 2024-11-18 | Warnings | M007 |
| Milk of Magnesia Concentrate | MAGNESIUM HYDROXIDE | PAI Holdings, LLC dba PAI Pharma | 2a99a1a8-a830-429f-9cfd-3f29c3d3547c | 2024-11-12 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | A-S Medication Solutions | 122486e9-74dd-4181-97d1-0b07688280f4 | 2024-11-06 | Warnings | M007 |
| Stratuscare Adult Glycerin | GLYCERIN | Stratus Pharmaceuticals | 3e1935da-5c1f-4942-98dd-320fade82321 | 2024-11-04 | Warnings | M007 |
| DOCUSATE SODIUM | DOCUSATE SODIUM | NuCare Pharmaceuticals,Inc. | fdf3c8e1-d554-4cdb-e053-6394a90a542e | 2024-11-01 | Warnings | M007 |
| 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 |
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 |