DOCUSATE SODIUM, EXTRA STRENGTH
- Product NDC
- 80513-101
- 11-digit product format
- 805130101
- Labeler code
- 80513
- Product ID
- 80513-101_55fe1154-f793-7cb6-e063-6294a90aad06
- 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
- 2023-05-25
- Marketing end
- 2028-12-31
- Substance
- DOCUSATE SODIUM
- Active strength
- 250 mg/1
- NDC exclude flag
- No
- 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
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 |
|---|---|
| fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80513-101-01 | DOCUSATE SODIUM, EXTRA STRENGTH250 MG | 100 in 1 BOTTLE | CAPSULE, GELATIN COATED | 100 | 2 |
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 | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | f4671579-aed0-4f93-ab83-248e0d72b5b0 | 2026-08-10 | Warnings | M007 |
| Docusate Sodium Liquid | DOCUSATE SODIUM.50MG/5ML | Aldama Pharmaceuticals, Inc | 492b6d37-47cf-3a28-e063-6294a90a2a18 | 2026-08-10 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Safeway Inc | 0b757160-f9eb-4413-9b43-97544c49c72f | 2026-08-10 | Warnings, Adverse reactions | M007 |
| Bisacodyl Laxative | BISACODYL | InvaDerm Corporation | 58ba9a9f-98d8-c380-e063-6294a90a774c | 2026-08-10 | Warnings | M007 |
| Sennosides | SENNOSIDES | Cardinal Health 107, LLC | 4a9e1cbe-ffe4-462f-a86d-078a357dcf49 | 2026-08-07 | Warnings | M007 |
| Senna S | DOCUSATE SODIUM, SENNOSIDES | Shield Pharmaceuticals Corp | 0be906d8-3db5-4218-bbdf-f1d126007990 | 2026-08-07 | Warnings | M007 |
| MiraFAST KIDS soft chews | MAGNESIUM HYDROXIDE | Bayer HealthCare LLC. | 58636827-239d-cc63-e063-6294a90a6180 | 2026-08-06 | Warnings | M007 |
| Stool Softener Extra Strength | DOCUSATE SODIUM | P & L Development, LLC | 4e97dd60-96e3-4b51-b614-c62480af1919 | 2026-08-06 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | P & L Development, LLC | 098d2377-0019-45fe-b995-700b1b1241c4 | 2026-08-05 | Warnings | M007 |
| Docusate Sodium softgels 50mg (Dye Free) | DOCUSATE SODIUM | CVS Pharmacy | 273ea95f-3c9c-98e8-e063-6294a90a2135 | 2026-08-05 | Warnings | M007 |
| Mineral Oil | MINERAL OIL | Old East Main Co. | 4bae831d-caba-40c9-bdb5-2611eac35dd5 | 2026-08-05 | Warnings, Adverse reactions | M007 |
| Metamucil Therapy for regularity | PSYLLIUM HUSK | Atlantic Biologicals Corp. | 57b112ea-f6b1-baa6-e063-6394a90a3b29 | 2026-08-05 | Warnings | M007 |
| MiraSOFT Stool Softener | DOCUSATE SODIUM | Bayer HealthCare LLC. | 5851f15f-8add-559f-e063-6394a90a7b7d | 2026-08-05 | Warnings | M007 |
| WinCo Pure 5lb | PURE 5LB EPSOM SALT | WinCo Foods, LLC | 58529382-a192-cda2-e063-6394a90adb69 | 2026-08-05 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | P & L Development, LLC | cbb0edf4-1fa7-42f5-a6f7-027e3961b50a | 2026-08-05 | Warnings | M007 |
| Sennosides | SENNOSIDES | LEADER/ Cardinal Health 110, Inc. | e3c7ece8-82f3-cd0c-e053-2995a90ad800 | 2026-08-04 | Warnings | M007 |
| CVS Glycerin | GLYCERIN SUPPOISITORY | CVS Pharmacy, Inc | ca6d13db-60e8-4fcc-b7b3-3eb280b8c435 | 2026-08-04 | Warnings | M007 |
| Colace | DOCUSATE SODIUM | Atlantis Consumer Healthcare, Inc. | 7793fced-e8ee-44e2-b212-dd2a59a5f462 | 2026-08-04 | Warnings | M007 |
| Dual Action Senna Stool Softener | DOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MG | Shield Pharmaceuticals Corp | a04435df-aace-497f-a3a8-d8e8489db661 | 2026-08-03 | Warnings | M007 |
| Docusate Sodium - Stool Softener Laxative | DOCUSATE SODIUM | Cardinal Health 107, LLC | b5e4b14d-bf11-4309-bf6d-65ee9d877a24 | 2026-07-28 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1245468 | docusate sodium 250 MG Oral Capsule | PSN | fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 | 2 |
| 1245468 | docusate sodium 250 MG Oral Capsule | SCD | fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 | 2 |
| 1245468 | DOSS Sodium 250 MG Oral Capsule | SY | fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80513-101-01 | 80513010101 | 100 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-101-01) | 2023-05-25 | 2028-12-31 | No | No | Historical |