DOCUSATE SODIUM, EXTRA STRENGTH
- Product NDC
- 80513-100
- 11-digit product format
- 805130100
- Labeler code
- 80513
- Product ID
- 80513-100_220d2464-6ee6-10d6-e063-6394a90a4f39
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DOCUSATE SODIUM
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Advanced Rx LLC
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-09-15
- Substance
- DOCUSATE SODIUM
- Active strength
- 250 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
- DOCUSATE SODIUM, EXTRA STRENGTH
- Brand name suffix
- 250 MG
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOCUSATE SODIUM | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F05Q2T2JA0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1245468 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e8be12c5-c591-eadd-e053-2a95a90a431b | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80513-100-01 | DOCUSATE SODIUM, EXTRA STRENGTH250 MG | 100 in 1 BOTTLE | CAPSULE, GELATIN COATED | 100 | 4 |
DailyMed Dashboard NDC Coverage#
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 | Sam's West, Inc | b14d2495-1092-4063-869f-73a7e8c28708 | 2024-05-21 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Safeway, Inc. | 6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d | 2024-05-15 | Warnings | M007 |
| Stool Softener Plus Stimulant Laxative | DOCUSATE SODIUM AND SENNOSIDES | Safeway, Inc. | c0898583-4bbb-41d5-9e84-00cca823024f | 2024-05-15 | Warnings | M007 |
| Senna S | DOCUSATE SODIUM SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 9c986ca8-d540-49c1-b092-94c1bf837c07 | 2024-05-09 | Warnings | M007 |
| Fleet | GLYCERIN | C.B. Fleet Company, Inc. | 381f4179-0c3b-41f8-927c-c88534ebe06d | 2024-05-06 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | NuCare Pharmaceuticals,Inc. | ed20d198-e935-200e-e053-2a95a90a309b | 2024-05-02 | Warnings | M007 |
| Sennosides, Docusate Sodium | SENNOSIDES, DOCUSATE SODIUM | Major Pharmaceuticals | 1768b470-2808-fa46-e063-6394a90ac8d9 | 2024-05-01 | Warnings | M007 |
| Stool Softener Stimulant laxative | DOCUSATE SODIUM AND SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 9467e1f7-19bb-4fb3-853b-75c4d28bb9a9 | 2024-05-01 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | QUALITY CHOICE (Chain Drug Marketing Association) | 72f8e8d7-ee38-4bd3-8711-f11fded0cede | 2024-05-01 | Warnings | M007 |
| Stool Softener Laxative Extra Strength | DOCUSATE SODIUM | P & L Development, LLC | c1e9863a-c229-4694-b450-6b0e0ad37503 | 2024-04-30 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | QUALITY CHOICE (Chain Drug Marketing Association) | 96c7f8bc-be95-40d1-9977-44b7cc6582df | 2024-04-22 | Warnings | M007 |
| Pedia-Lax | MAGNESIUM HYDROXIDE | C.B. Fleet Company, Inc. | 975f24d8-218c-40f4-84a5-558acf34329d | 2024-04-11 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM AND SENNOSIDES | H E B | 2f9e2723-53a7-47a8-8c41-87bffc4e50dd | 2024-04-09 | Warnings | M007 |
| Senna | SENNOSIDES | H E B | d047e4e9-b8ac-498e-9fde-8af5d415edaa | 2024-04-09 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | H E B | 5b8bcc6c-de03-4d73-a76f-6f4c371cf250 | 2024-04-09 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | H E B | 1dd2be7e-bdca-4e43-b853-3ed10b636632 | 2024-04-08 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Bryant Ranch Prepack | 1f11cf85-b094-4ca4-8b48-2d3a9093304b | 2024-04-04 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | TARGET Corporation | 89106733-69f1-469b-9d07-f06ac09b2fb6 | 2024-04-02 | Warnings | M007 |
| Stool Softener Laxative Plus Stimulant | DOCUSATE SODIUM AND SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 89dc2063-6744-4412-89be-90990090b57c | 2024-03-19 | Warnings | M007 |
| Senna Laxative | SENNOSIDES | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 2322765d-6f08-48d4-a500-818a8a558f6f | 2024-03-19 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1245468 | docusate sodium 250 MG Oral Capsule | PSN | e8be12c5-c591-eadd-e053-2a95a90a431b | 4 |
| 1245468 | docusate sodium 250 MG Oral Capsule | SCD | e8be12c5-c591-eadd-e053-2a95a90a431b | 4 |
| 1245468 | DOSS Sodium 250 MG Oral Capsule | SY | e8be12c5-c591-eadd-e053-2a95a90a431b | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80513-100-01 | 80513010001 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-100-01) | 2022-09-15 | 0000-00-00 | No | No | Current |