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 |
|---|---|---|---|---|---|---|
| Well at Walgreens Castor Oil | CASTOR OIL | Walgreen Co. | e41f8553-3812-4d0b-95f8-20b261279299 | 2026-02-12 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Walgreen Co. | b5a02809-6e01-4e01-b1c3-2b10c5091a4e | 2026-02-12 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | Walgreen Co. | 822fd02a-92b0-4010-8bfb-737dba331d54 | 2026-02-12 | Warnings, Adverse reactions | M007 |
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | Rugby Laboratories | 5fd89979-903e-4b31-872d-3b8974af3a6b | 2026-02-09 | Warnings | M007 |
| Epsom Salt | EPSOM SALT | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 1845ea0c-0cb6-482b-abe6-fa17785c5b90 | 2026-02-09 | Warnings | M007 |
| Colace Fast-Acting Saline Laxative | MAGNESIUM HYDROXIDE | Atlantis Consumer Healthcare, Inc. | 572adfaf-6e26-42e5-b65d-6d356a0bdfa9 | 2026-02-06 | Warnings | M007 |
| Castor Oil | CASTOR OIL | Retail Business Services, LLC | 4e9c41fa-f240-4986-bb13-541bfeb0e50b | 2026-02-06 | Warnings | M007 |
| citroma | MAGNESIUM CITRATE | Retail Business Services, LLC | f3661952-ef4f-4f29-93e6-ec09b8464365 | 2026-02-06 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | Retail Business Services, LLC | 2f6e9f87-4bff-482b-a54f-f51ca99aac8c | 2026-02-06 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Retail Business Services, LLC | 1a8b540c-b66e-4dca-b7af-23705ae247b6 | 2026-02-06 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | Retail Business Services, LLC | b0abcdf9-c226-424f-8970-c2135708c6c8 | 2026-02-06 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Publix Super Markets, Inc. | e985e071-5541-456e-ae4d-dba85287fe75 | 2026-02-05 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | Discount Drug Mart | a82a4aa9-c8af-4383-9d92-ba6c596f0095 | 2026-02-04 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Discount Drug Mart | b05a94d2-5cc6-4989-9fb8-096e54fa7852 | 2026-02-04 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Grocery Outlet, Inc. | 3dff4b00-e71a-1dc0-e063-6394a90a715f | 2026-02-04 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | HARRIS TEETER | 73065a04-b7cd-437d-9624-f845f5ec93bf | 2026-02-04 | Warnings, Adverse reactions | M007 |
| Harris Teeter | MINERAL | Harris Teeter | 401e3a7e-54be-47cc-88c3-a343f5cbbd10 | 2026-02-04 | Warnings, Adverse reactions | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Hy-Vee, Inc. | 45374a86-80a4-481c-e063-6294a90a381a | 2026-02-04 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Hy-Vee, Inc. | 44592ee0-13dd-57b1-e063-6394a90ab402 | 2026-02-04 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | CVS Pharmacy, Inc. | a78d991a-ba21-4bc4-b8f9-f8dafbddc28f | 2026-02-03 | 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 |