DOCUSATE SODIUM 100mg Two-Tone
- Product NDC
- 53345-018
- 11-digit product format
- 533450018
- Labeler code
- 53345
- Product ID
- 53345-018_2767f5d0-11e2-5dbb-e063-6394a90a364c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DOCUSATE SODIUM
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-12-23
- Substance
- DOCUSATE SODIUM
- Active strength
- 100 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 100mg Two-Tone
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOCUSATE SODIUM | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F05Q2T2JA0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1115005 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 85c64624-428d-46fa-8071-f42b8feec049 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53345-018-01 | DOCUSATE SODIUM 100mg Two-Tone | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 5 | |
| 53345-018-01 | DOCUSATE SODIUM 100mg Two-Tone | 20000 in 1 BAG | CAPSULE, LIQUID FILLED | 20000 | 5 | |
| 53345-018-02 | DOCUSATE SODIUM 100mg Two-Tone | 15000 in 1 BAG | CAPSULE, LIQUID FILLED | 15000 | 5 | |
| 53345-018-02 | DOCUSATE SODIUM 100mg Two-Tone | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53345-018 | DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20241122_85c64624-428d-46fa-8071-f42b8feec049.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 |
|---|---|---|---|---|---|---|
| Mineral Oil | MINERAL OIL | United Natural Foods, Inc. dba UNFI | cb7bc571-295f-47c2-ae93-18cba194752c | 2026-02-17 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | Strategic Sourcing Services LLC | e4965086-dcc0-4b34-bb30-81facf7139f3 | 2026-02-17 | Warnings, Adverse reactions | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Valu Merchandisers Company | cd3e5836-b2f0-41f3-8623-3105c4642491 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| citroma | MAGESIUM CITRATE | Valu Merchandisers Company | a693f6b0-0679-4609-9ca0-dddfa4158c02 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | Valu Merchandisers Company | fb358bc3-e479-42e7-8aea-a6a3676f2430 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Valu Merchandisers Company | ff539c1c-9ed3-49be-9b30-1858f12e1e90 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| Castor Oil | CASTOR OIL | United Natural Foods, Inc. dba UNFI | bd19bea3-5ac9-4f8d-b1a0-478fd9c8a01f | 2026-02-16 | Warnings, Adverse reactions | M007 |
| Walgreens SmoothLAX Soft Chews | MAGNESIUM HYDROXIDE | Walgreens | 424e27ce-0b11-9cd2-e063-6294a90a3c21 | 2026-02-16 | Warnings | M007 |
| citroma | MAGNESIUM CITRATE | United Natural Foods, Inc. dba UNFI | da013c15-3531-4dc5-b122-bfc99bc494ae | 2026-02-16 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | United Natural Foods, Inc. dba UNFI | db1bc651-1a35-4f92-a917-c6a19f421594 | 2026-02-16 | Warnings, Adverse reactions | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | The Kroger Co. | e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b | 2026-02-13 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Topco Associates LLC | b2ec06b3-647d-49ab-a392-6db63d96d1e3 | 2026-02-13 | Warnings, Adverse reactions | M007 |
| Castor Oil | CASTOR OIL | Topco Associates LLC | 5643f2e0-93e2-4c2e-90a0-fd152150d18a | 2026-02-13 | Warnings, Adverse reactions | M007 |
| citroma | MAGESIUM CITRATE | Topco Associates LLC | d3cc7cb6-098e-413c-b1ad-7ebf5fa35269 | 2026-02-13 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | Topco Associates LLC | bc89c4bc-5207-479d-9a3b-e570b412a7ba | 2026-02-13 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Topco Associates LLC | 72f69aa0-381a-4e5c-975d-3a73fdc1b377 | 2026-02-13 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | Topco Associates LLC | e9b1fd61-c229-4529-82c2-d6ac5b076082 | 2026-02-13 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Pinnacle RX LLC | 4abbb0e4-e005-bc4e-e063-6394a90a126a | 2026-02-13 | Warnings, Adverse reactions | M007 |
| 365 Whole Foods Market Epsom Salt | MAGNESIUM SULFATE | Whole Foods Market, Inc. | 4147cdd0-57f6-3857-e063-6394a90afecb | 2026-02-12 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Your Military Exchanges | 27cff497-123c-424a-9c43-57740c00168b | 2026-02-12 | Warnings, Adverse reactions | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1115005 | docusate sodium 100 MG Oral Capsule | PSN | 85c64624-428d-46fa-8071-f42b8feec049 | 5 |
| 1115005 | docusate sodium 100 MG Oral Capsule | SCD | 85c64624-428d-46fa-8071-f42b8feec049 | 5 |
| 1115005 | DOSS Sodium 100 MG Oral Capsule | SY | 85c64624-428d-46fa-8071-f42b8feec049 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53345-018-01 | 53345001801 | 1 BAG in 1 BOX (53345-018-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2013-12-23 | 0000-00-00 | No | No | Current |
| 53345-018-02 | 53345001802 | 1 BAG in 1 BOX (53345-018-02) / 15000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2013-12-23 | 0000-00-00 | No | No | Current |