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 |
|---|---|---|---|---|---|---|
| Magnesium Citrate | FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPE | Pharma Nobis, LLC | f0488c86-6c74-3987-e053-2a95a90a31b4 | 2023-12-22 | Warnings | M007 |
| Mineral Oil Heavy | MINERAL OIL | Pharma Nobis, LLC | e42f6c6d-c4de-02c6-e053-2995a90a3ace | 2023-12-22 | Warnings | M007 |
| Quality Choice Castor Oil | CASTOR OIL | Chain Drug Market Asociation | 18d7124f-7745-45b2-adc4-cb1103add5d6 | 2023-12-20 | Warnings | M007 |
| Premiere Value Castor Oil | CASTOR OIL | Chain Drug Consortium | 5c8c1564-fcff-894b-e053-2991aa0a9c0b | 2023-12-20 | Warnings | M007 |
| Magnesium Citrate | BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRY | Bionpharma, Inc. | f0fa4b72-50a5-5c42-e053-2995a90a159a | 2023-12-20 | Warnings | M007 |
| Harris Teeter Castor Oil | CASTOR OIL | Harris Teeter, LLC | 5cca6b4b-d88f-1c7d-e053-2991aa0a051f | 2023-12-20 | Warnings | M007 |
| Magnesium Citrate | BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMON | Bionpharma, Inc. | f0f9c36e-c43b-05d2-e053-2995a90a6d65 | 2023-12-20 | Warnings | M007 |
| Magnesium Citrate | BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPE | Bionpharma, Inc. | f0f9ff19-ae08-0af0-e053-2a95a90ab842 | 2023-12-20 | Warnings | M007 |
| CVS Mineral Oil | MINERAL OIL | CVS | 9d7402e1-524b-1084-e053-2a95a90ae3af | 2023-12-20 | Warnings | M007 |
| Top Care Castor Oil | CASTOR OIL | TOPCO ASSOCIATES LLC | 8dce1a1f-e765-9c75-e053-2995a90abf9f | 2023-12-18 | Warnings | M007 |
| Humco Epson Salt | MAGNESIUM SULFATE | Humco Holding Group, Inc. | 7a9d1b77-6c39-46f1-86f2-4059dde20f85 | 2023-12-15 | Warnings | M007 |
| Humco Mineral Oil Heavy | MINERAL OIL | Humco Holding Group, Inc. | 9f943fdf-5058-4e18-ba96-6be112bf72ca | 2023-12-15 | Warnings | M007 |
| Rite Aid Castor Oil | CASTOR OIL | Rite Aid Corporation. | 5e0d3664-b01b-ba28-e053-2991aa0a8a4c | 2023-12-15 | Warnings | M007 |
| GNP Castor Oil | CASTOR OIL | Amerisource Bergen | 5d06bec6-f1e7-4f0c-e053-2991aa0a8ad8 | 2023-12-14 | Warnings | M007 |
| Sankaijo | DOCUSATE SODIUM, SENNOSIDES | Sato Pharmaceutical Co., Ltd. | 83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b | 2023-11-29 | Warnings | M007 |
| SIMPEX Bisacodyl laxative | BISACODYL | Simpex Pharma Pvt. Ltd | 5114ed64-4fec-401b-8a91-8df3e42b10b1 | 2023-11-29 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Geri-Care Pharmaceutical Corp | b595063a-5fee-18c2-e053-2a95a90a5b99 | 2023-11-15 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Publix | cbf7dcef-7623-b333-e053-2a95a90a0f1a | 2023-11-08 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | Meijer, Inc. | bb8b51e9-ba4a-270d-e053-2a95a90a318b | 2023-11-08 | Warnings | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | STRATEGIC SOURCING SERVICES LLC | ff0d4b9f-7ce8-dd98-e053-6394a90ab614 | 2023-11-08 | 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 |