Stool Softener Laxative
- Product NDC
- 36800-568
- 11-digit product format
- 368000568
- Labeler code
- 36800
- Product ID
- 36800-568_e80d6e87-9467-4014-98c1-05e85559c86f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docusate Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- TOP CARE (Topco Associates LLC)
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-11-29
- Marketing end
- 2026-08-29
- Substance
- DOCUSATE SODIUM
- Active strength
- 250 mg/1
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Stool Softener Laxative
- Brand name suffix
- Extra Strength
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 |
|---|---|
| 3f81e49a-9a0c-48fd-a2a3-9e665493bace | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-568-10 | Stool Softener LaxativeExtra Strength | 100 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 100 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-568 | STOOL SOFTENER LAXATIVE EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241115_3f81e49a-9a0c-48fd-a2a3-9e665493bace.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 |
|---|---|---|---|---|---|---|
| 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 |
| MiraFAST soft chews | MAGNESIUM HYDROXIDE | Bayer HealthCare LLC. | 2cee67dd-b71f-32b8-e063-6394a90ae864 | 2026-08-05 | Warnings | M007 |
| MiraSOFT Stool Softener | DOCUSATE SODIUM | Bayer HealthCare LLC. | 5851f15f-8add-559f-e063-6394a90a7b7d | 2026-08-05 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | P & L Development, LLC | cbb0edf4-1fa7-42f5-a6f7-027e3961b50a | 2026-08-05 | Warnings | M007 |
| Metamucil Therapy for regularity | PSYLLIUM HUSK | Atlantic Biologicals Corp. | 57b112ea-f6b1-baa6-e063-6394a90a3b29 | 2026-08-04 | Warnings | M007 |
| Sennosides | SENNOSIDES | LEADER/ Cardinal Health 110, Inc. | e3c7ece8-82f3-cd0c-e053-2995a90ad800 | 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 |
| Topwin Speedy Enema | GLYCERIN | Health Chemical Pharmaceutical Co., Ltd | 3ba8c3d2-1780-42e1-bec5-8f98771d475e | 2026-07-27 | Warnings | M007 |
| Curewell Senna Syrup | SENNOSIDES | RMT HEALTH LLC | 57345324-5140-5cde-e063-6294a90ab97c | 2026-07-22 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE ORAL SOLUTION | WALGREEN COMPANY | 4ffe54ae-3126-ba58-e063-6294a90a8877 | 2026-07-20 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | Bryant Ranch Prepack | deca083b-5c72-40fa-9021-b74028426a5a | 2026-07-20 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Cardinal Health 107, LLC | fc5e82b6-e25c-4686-9781-2205819685f5 | 2026-07-20 | Warnings | M007 |
| Best Choice Fiber Therapy Orange Flavor | PSYLLIUM HUSK | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 0b25f6c0-441b-41ef-ab19-2a29705a56c6 | 2026-07-17 | Warnings | M007 |
| Best Choice Fiber Therapy original coarse | PSYLLIUM HUSK | BEST CHOICE (VALU MERCHANDISERS COMPANY) | d7eb71af-17e3-465e-b464-f77b3be7266d | 2026-07-17 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1245468 | docusate sodium 250 MG Oral Capsule | PSN | 3f81e49a-9a0c-48fd-a2a3-9e665493bace | 3 |
| 1245468 | docusate sodium 250 MG Oral Capsule | SCD | 3f81e49a-9a0c-48fd-a2a3-9e665493bace | 3 |
| 1245468 | DOSS Sodium 250 MG Oral Capsule | SY | 3f81e49a-9a0c-48fd-a2a3-9e665493bace | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 36800-568-10 | 36800056810 | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (36800-568-10) | 2019-11-29 | 2026-08-29 | No | No | Current |