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 |
|---|---|---|---|---|---|---|
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Wal-Mart Stores, Inc. | 750e0355-369e-b679-e053-2a91aa0a66ca | 2023-11-01 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Wal-Mart Stores, Inc. | 750efd58-5845-fbc4-e053-2a91aa0a86d1 | 2023-11-01 | Warnings | M007 |
| Gentle Laxative | MAGNESIUM HYDROXIDE | WALGREEN COMPANY | ba4a29b3-2ddc-b906-e053-2995a90a2ab7 | 2023-11-01 | Warnings | M007 |
| DOCUZEN | SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG | Proficient Rx LP | 92879e62-f60a-4ab4-9532-610cdd2628ee | 2023-11-01 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | A-S Medication Solutions | 5999904a-6ac8-4d9e-951c-6e64e8cd93eb | 2023-11-01 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | VALU MERCHANDISERS COMPANY | 5e98f9d9-679c-63a2-e053-2991aa0a4b8d | 2023-10-31 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | VALU MERCHANDISERS COMPANY | 5e957b01-4f44-0a2a-e053-2991aa0a37a0 | 2023-10-31 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | VALU MERCHANDISERS COMPANY | 5e993b13-8dc8-6653-e053-2a91aa0a4c2a | 2023-10-31 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | CVS | 3c8e4144-6702-2678-e054-00144ff88e88 | 2023-10-31 | Warnings | M007 |
| Fiber Laxative | CALCIUM POLYCARBOPHIL | Magno-Humphries, Inc. | 9d22c208-d089-8b6a-e053-2995a90ab90a | 2023-10-27 | Warnings | M007 |
| Stool Softener Docusate Sodium | DOCUSATE SODIUM | Magno-Humphries, Inc. | a0e6ab9b-fd31-45fd-93d5-b51d705c180a | 2023-10-27 | Warnings | M007 |
| Sennosides Natural Laxative | SENNOSIDES | Magno-Humphries, Inc. | 9d22bedb-9fca-8421-e053-2a95a90acf4a | 2023-10-27 | Warnings | M007 |
| Stool Softener Docusate Sodium | DOCUSATE SODIUM | Magno-Humphries, Inc. | 9d22d642-8aed-d17e-e053-2995a90ae182 | 2023-10-27 | Warnings | M007 |
| Senna S | DOCUSATE SODIUM, SENNOSIDES | Magno-Humphries, Inc. | 9deaf264-6af0-40ba-e053-2a95a90ada0e | 2023-10-27 | Warnings | M007 |
| FLEET | MINERAL OIL | C.B. Fleet Company, Inc. | 2528cb5e-437e-41f0-9c34-e9ce57404d8b | 2023-10-26 | Warnings | M007 |
| Magnesium Citrate | MAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Major Pharmaceuticals | 088e5543-c947-af78-e063-6294a90a8bc4 | 2023-10-25 | Warnings | M007 |
| DOK | DOCUSATE SODIUM | MAJOR PHARMACEUTICALS | 7a92070d-98cc-662f-e053-2991aa0aa1b2 | 2023-10-23 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | KROGER COMPANY | a1afaa71-7e8c-5a49-e053-2a95a90a4db0 | 2023-10-23 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Geri-Care Pharmaceutical Corp | 644d81ec-d38f-4172-a087-727b94e2fefe | 2023-10-19 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | Asclemed USA, Inc. | 30fc8c07-c26b-4bcc-a727-6e193f5727fd | 2023-10-16 | 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 |