COLACE EXTRA STRENGTH
- Product NDC
- 67618-201
- 11-digit product format
- 676180201
- Labeler code
- 67618
- Product ID
- 67618-201_cb4d4f5a-9ae0-4cab-9806-017c6088f77f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docusate Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Atlantis Consumer Healthcare Inc.
- Application
- M007
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-05
- Substance
- DOCUSATE SODIUM
- Active strength
- 250 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
- COLACE EXTRA STRENGTH
- Brand name suffix
- STOOL SOFTNER
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DOCUSATE SODIUM | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| F05Q2T2JA0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 34e06b05-64a5-4b3e-af38-cdcd7c1d521b | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67618-201-12 | COLACE EXTRA STRENGTHSTOOL SOFTNER | 2 in 1 PACKAGE | CAPSULE, LIQUID FILLED | 2 | 3 | |
| 67618-201-12 | COLACE EXTRA STRENGTHSTOOL SOFTNER | 60 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 60 | 3 | |
| 67618-201-60 | COLACE EXTRA STRENGTHSTOOL SOFTNER | 60 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 60 | 3 |
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 |
|---|---|---|---|---|---|---|
| Mineral Oil | MINERAL OIL | Better Living Brands, LLC | 7f2f1b30-497a-4c53-accc-8455169b17b3 | 2026-02-24 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | Family Dollar Stores, Inc | cc97cfb5-cd40-4589-942a-5bee611a2812 | 2026-02-24 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | Family Dollar Stores, Inc | 0ac1896d-7ed9-44e5-bf07-147826237273 | 2026-02-24 | Warnings, Adverse reactions | M007 |
| Castor Oil | CASTOR OIL | Chain Drug Marketing Association | 4a003bb1-425d-cd97-e063-6294a90a5dda | 2026-02-23 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | Better Living Brands, LLC | d8176ef6-cc68-4185-b5eb-e887562f6aaa | 2026-02-23 | Warnings, Adverse reactions | M007 |
| citroma | MAGNESIUM CITRATE | Better Living Brands, LLC | 07732845-c9ce-47bb-8b63-36a3d5ddf8b7 | 2026-02-23 | Warnings, Adverse reactions | M007 |
| stimulant laxative | BISACODYL | BIONPHARMA INC. | 4b1f7db3-c6a8-7f6a-e063-6394a90a5829 | 2026-02-22 | Warnings | M007 |
| Castor Oil | CASTOR OIL | Nice-Pak Products, LLC | ff6c8022-9522-4eae-b8ff-994ee37fba06 | 2026-02-19 | Warnings, Adverse reactions | M007 |
| Castor Oil | CASTOR OIL | Perrigo Direct, Inc | 09e32476-1c60-4f1e-a51c-5fab2e744b30 | 2026-02-19 | Warnings, Adverse reactions | M007 |
| citroma | MAGESIUM CITRATE | Perrigo Direct, Inc | 22991685-8228-41e1-a13e-f57961e8dd0e | 2026-02-19 | Warnings, Adverse reactions | M007 |
| citroma | MAGESIUM CITRATE | Perrigo Direct, Inc | 24478279-9a11-4e12-956d-57dc7debf941 | 2026-02-19 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | Perrigo Direct, Inc | f1656280-fad9-4922-9d5c-be774a8b1422 | 2026-02-19 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Meijer, Inc. | 3b8eae67-9e27-46bd-ab2b-02c719786bab | 2026-02-19 | Warnings, Adverse reactions | M007 |
| Castor Oil | CASTOR OIL | Meijer, Inc. | c4d03837-193b-4817-8b78-fbdfb9122f19 | 2026-02-19 | Warnings, Adverse reactions | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Meijer, Inc. | 2070a4a6-7968-49f2-84ec-53bd1cd82445 | 2026-02-19 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | Meijer, Inc. | 652d1da9-a71f-4113-9ef3-da0916724625 | 2026-02-19 | Warnings, Adverse reactions | M007 |
| SENNA-S | DOCUSATE SODIUM AND SENNOSIDES | Advanced Rx LLC | d148be81-79b4-41f7-b8d8-a0e85b661592 | 2026-02-18 | Warnings | M007 |
| citroma | MAGNESIUM CITRATE | Target Corporation | a8e52a22-7c30-40c0-8f78-523775743bfb | 2026-02-18 | Warnings, Adverse reactions | M007 |
| Mineral Oil | MINERAL OIL | Target Corporation | 526508f0-e908-4e3d-88f5-404a95f6de76 | 2026-02-18 | Warnings, Adverse reactions | M007 |
| CVS Pharmacy | SALINE LAXATIVE | CVS Pharmacy | edd58c52-18de-4ec4-aec3-44f3e17607a7 | 2026-02-17 | Warnings | M007 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2692740 | Colace 250 MG Oral Capsule | PSN | 34e06b05-64a5-4b3e-af38-cdcd7c1d521b | 3 |
| 1245468 | docusate sodium 250 MG Oral Capsule | PSN | 34e06b05-64a5-4b3e-af38-cdcd7c1d521b | 3 |
| 2692740 | docusate sodium 250 MG Oral Capsule [Colace] | SBD | 34e06b05-64a5-4b3e-af38-cdcd7c1d521b | 3 |
| 1245468 | docusate sodium 250 MG Oral Capsule | SCD | 34e06b05-64a5-4b3e-af38-cdcd7c1d521b | 3 |
| 2692740 | Colace 250 MG Oral Capsule | SY | 34e06b05-64a5-4b3e-af38-cdcd7c1d521b | 3 |
| 1245468 | DOSS Sodium 250 MG Oral Capsule | SY | 34e06b05-64a5-4b3e-af38-cdcd7c1d521b | 3 |
| 2692740 | DOSS sodium 250 MG Oral Capsule [Colace] | SY | 34e06b05-64a5-4b3e-af38-cdcd7c1d521b | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 67618-201-12 | 67618020112 | 2 BOTTLE in 1 PACKAGE (67618-201-12) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE | 2 bottle | 2025-07-01 | No | No | Current |
| 67618-201-60 | 67618020160 | 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (67618-201-60) | 2024-08-05 | No | No | Current |