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 |
|---|---|---|---|---|---|---|
| MILK OF MAGNESIA MINT | MAGNESIUM HYDROXIDE | Preferred Pharmaceuticals Inc. | f8bba8cb-a111-4285-8bdb-2273a049c3bb | 2026-07-08 | Warnings | M007 |
| DOCUSATE SODIUM, EXTRA STRENGTH 250 MG | DOCUSATE SODIUM | Advanced Rx LLC | fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 | 2026-07-06 | Warnings | M007 |
| Curewell Docusate Sodium Liquid | DOCUSATE SODIUM.50MG/5ML | RMT HEALTH LLC | 55903043-2a1d-0525-e063-6394a90ae182 | 2026-07-01 | Warnings | M007 |
| Senna | SENNOSIDES 8.6 MG TABLETS | Aarkish Pharmaceuticals NJ Inc. | 564bc9a5-13b5-4cce-a349-6b2e122683ed | 2026-07-01 | Warnings | M007 |
| Senna-S | DOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MG | Aarkish Pharmaceuticals NJ Inc. | faca8f3e-d9eb-44c5-93ab-f59ed1c0f56f | 2026-07-01 | Warnings | M007 |
| ENEMEEZ | DOCUSATE SODIUM | Quest Products, LLC | 0b06445d-0839-497e-bdff-e0fe224a7738 | 2026-06-30 | Warnings | M007 |
| ENEMEEZ Plus | DOCUSATE SODIUM AND BENZOCAINE | Quest Products, LLC | 1670ca59-7275-4ac6-bef4-674a7b24c7b3 | 2026-06-30 | Warnings | M007 |
| Mineral oil | MINERAL OIL | CVS Pharmacy, Inc. | 1183bcbc-51ec-e53a-e063-6394a90af0f2 | 2026-06-26 | Warnings, Adverse reactions | M007 |
| Glycerin | GLYCERIN | Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd | 552d9018-cc7d-7e1a-e063-6294a90a3322 | 2026-06-26 | Warnings | M007 |
| Glycerin | GLYCERIN | Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd | 552e16b9-f46a-7838-e063-6394a90ab8aa | 2026-06-26 | Warnings | M007 |
| Walgreens Gentle Laxative | BISACODYL SUPPOSITORY | Walgreens | 20c43036-830b-0e1d-e063-6394a90adf5f | 2026-06-25 | Warnings | M007 |
| Docusate Sodium | DOCUSATE SODIUM | American Health Packaging | be7cab51-ce7e-465d-95db-083e69288cfd | 2026-06-25 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Vi-Jon, LLC | ba490c22-19f0-4887-9509-bd3d32e0f5b1 | 2026-06-24 | Warnings, Adverse reactions | M007 |
| MILK OF MAGNESIA | MAGNESIUM HYDROXIDE | KROGER COMPANY | a1b0c638-6c34-1b72-e053-2995a90acc85 | 2026-06-24 | Warnings | M007 |
| Womens Laxative | WOMENS LAXTIVE | Allegiant Health | 549a11d1-a096-4c22-96b4-2d4f54f46022 | 2026-06-24 | Warnings | M007 |
| Magnesium Citrate | MAGNESIUM CITRATE | Meijer Distribution Inc | f4259fda-19d4-087e-e053-2995a90a7081 | 2026-06-22 | Warnings | M007 |
| STOOL SOFTENER | DOCUSATE SODIUM | Geri-Care Pharmaceuticals, Corp | 3ec42148-6786-22f2-e054-00144ff8d46c | 2026-06-18 | Warnings | M007 |
| Glycerin | GLYCERIN SUPPOSITORY | Everpharm LLC | 546347e5-841e-15ca-e063-6294a90a0c8b | 2026-06-16 | Warnings | M007 |
| Glycerin | GLYCERIN SUPPOSITORY | Everpharm LLC | 5463f869-2b92-4551-e063-6394a90ad6f9 | 2026-06-16 | Warnings | M007 |
| MINICA-S | GLYCERIN | Sato Pharmaceutical Co., Ltd. | 687902eb-e702-4e87-a0ce-9add05e3cbc1 | 2026-06-16 | 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 |