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 |
|---|---|---|---|---|---|---|
| PHILLIPS FRESH MINT MILK OF MAGNESIA | PHILLIPS FRESH MINT MILK OF MAGNESIA | Bayer HealthCare LLC. | 0a59f9c3-c14e-2824-e054-00144ff8d46c | 2025-12-04 | Warnings | M007 |
| CVS Mini Enema | DOCUSATE SODIUM W/BENZOCAINE | CVS HEALTH | ca00c520-410a-1905-e053-2995a90a56f0 | 2025-12-04 | Warnings | M007 |
| Docusate Mini Enema | DOCUSATE SODIUM | Major Pharmaceuticals | 91099e15-94d7-b684-e053-2a95a90a574e | 2025-12-04 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Geri-Care Pharmaceutical Corp | 1057c0bf-4bf6-ea17-e063-6294a90a5984 | 2025-12-04 | Warnings | M007 |
| PHILLIPS ORIGINAL MILK OF MAGNESIA | PHILLIPS ORIGINAL MILK OF MAGNESIA | Bayer HealthCare LLC. | 0a57bb45-d4f7-443b-e054-00144ff8d46c | 2025-12-04 | Warnings | M007 |
| Equalactin Laxative | CALCIUM POLYCARBOPHIL | NUMARK BRANDS, INC | 2feed33a-3b7f-11c6-6e62-c99150ecfddd | 2025-12-03 | Warnings | M007 |
| Gentle Laxative Stimulant Laxative | BISACODYL | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | bcd3c07d-bd83-4452-9736-35c85db30c15 | 2025-12-03 | Warnings | M007 |
| Quality Choice Fiber Laxative | PSYLLIUM HUSK | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 2ee637c4-c4c6-4a24-ae99-612205afd592 | 2025-12-03 | Warnings | M007 |
| Quality Choice | CALCIUM POLYCARBOPHIL | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | f1e69c65-c1b0-459f-9a12-b1a92b90036b | 2025-12-03 | Warnings | M007 |
| CDMA Fiber Therapy | METHYLCELLULOSE | CHAIN DRUG MARKETING ASSOCIATION | 62bbcaf2-1d0c-485f-9159-685700aa3418 | 2025-12-03 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Reliable 1 Laboratories LLC | 44fae161-3fc8-64c4-e063-6294a90a1d26 | 2025-12-02 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | RMT HEALTH LLC | 44fbb197-fe90-c5a8-e063-6394a90adb7d | 2025-12-02 | Warnings | M007 |
| Fiber Lax | CALCIUM POLYCARBOPHIL | Rugby Laboratories | 318d81ed-0b06-4d21-8b97-2d1f0267c781 | 2025-12-02 | Warnings | M007 |
| Magnesium Citrate | EPIC MEDICAL MAGNESIUM CITRATE ORAL SOLUTION - LEMON | 4 Visions LLC | 44fe65d0-ee46-1d95-e063-6294a90abb71 | 2025-12-02 | Warnings | M007 |
| FIBER TABS | CALCIUM POLYCARBOPHIL | Major Pharmaceuticals | bee100da-b9c9-4261-b6e6-7b3db5715625 | 2025-12-02 | Warnings | M007 |
| Quality Choice Stool Softener | DOCUSATE SODIUM | Chain Drug Marketing Association | b1440ab7-a7d5-4153-8143-cffad73120f5 | 2025-12-02 | Warnings | M007 |
| Walgreen Fiber Lax | CALCIUM POLYCARBOPHIL | WALGREENS CO. | 9cbe1798-e0dc-4a90-bd91-8696fc59b2a6 | 2025-11-25 | Warnings | M007 |
| Walgreens Fiber Therapy | METHYLCELLULOSE | WALGREENS CO. | 6401a2c3-5869-4898-81db-3cd7151ca69a | 2025-11-25 | Warnings | M007 |
| Walgreens Senna Laxative | SENNOSIDES | WALGREENS CO. | a95bd796-d85e-4599-bbb1-2170088fa937 | 2025-11-25 | Warnings | M007 |
| Walgreens Stool Softener Fruit Punch | DOCUSATE SODIUM | WALGREENS CO. | 8428c81d-227a-4b0f-9a47-71d6a6983842 | 2025-11-25 | 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 |