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
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 |
|---|---|---|---|---|---|---|
| CVS Health Childrens Saline Laxative | MAGNESIUM HYDROXIDE | CVS PHARMACY,INC. | e57e5529-2190-4c66-8397-bc2848739e59 | 2026-08-14 | Warnings | M007 |
| Docusate Sodium and Sennosides | DOCUSATE SODIUM AND SENNOSIDES | Morepen Bio Inc | 562d1b9a-09d8-92fc-e063-6394a90a1993 | 2026-08-14 | Warnings | M007 |
| CVS Health | NATURAL FIBER SUPPLEMENT | CVS Pharmacy,Inc. | 04dbe9aa-ed18-4d76-a840-d010445a8643 | 2026-08-14 | Warnings | M007 |
| CVS Fiber Therapy | METHYLCELLULOSE | CVS PHARMACY | e066f5bd-5f34-4e04-beec-3c7d6db49381 | 2026-08-13 | Warnings | M007 |
| Mineral oil | MINERAL OIL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 92f2147d-b52d-4282-b217-28f6095dca0e | 2026-08-12 | Warnings | M007 |
| CAREONE Orange Flavored | PSYLLIUM HUSK | FOODHOLD USA | 4b1cccd2-e941-4d51-9924-4ca35e3a4429 | 2026-08-11 | Warnings | M007 |
| CAREONE | PSYLLIUM HUSK | FOODHOLD USA | 3ec3ead0-382e-4765-bbe8-b21e7c7b42a6 | 2026-08-11 | Warnings | M007 |
| Stool Softener | DOCUSATE SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | f4671579-aed0-4f93-ab83-248e0d72b5b0 | 2026-08-10 | Warnings | M007 |
| Docusate Sodium Liquid | DOCUSATE SODIUM.50MG/5ML | Aldama Pharmaceuticals, Inc | 492b6d37-47cf-3a28-e063-6294a90a2a18 | 2026-08-10 | Warnings | M007 |
| Epsom Salt | MAGNESIUM SULFATE | Safeway Inc | 0b757160-f9eb-4413-9b43-97544c49c72f | 2026-08-10 | Warnings, Adverse reactions | M007 |
| Senna S | DOCUSATE SODIUM, SENNOSIDES | Shield Pharmaceuticals Corp | 0be906d8-3db5-4218-bbdf-f1d126007990 | 2026-08-07 | Warnings | M007 |
| MiraFAST KIDS soft chews | MAGNESIUM HYDROXIDE | Bayer HealthCare LLC. | 58636827-239d-cc63-e063-6294a90a6180 | 2026-08-06 | Warnings | M007 |
| Stool Softener Extra Strength | DOCUSATE SODIUM | P & L Development, LLC | 4e97dd60-96e3-4b51-b614-c62480af1919 | 2026-08-06 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | P & L Development, LLC | 098d2377-0019-45fe-b995-700b1b1241c4 | 2026-08-05 | Warnings | M007 |
| Docusate Sodium softgels 50mg (Dye Free) | DOCUSATE SODIUM | CVS Pharmacy | 273ea95f-3c9c-98e8-e063-6294a90a2135 | 2026-08-05 | Warnings | M007 |
| Mineral Oil | MINERAL OIL | Old East Main Co. | 4bae831d-caba-40c9-bdb5-2611eac35dd5 | 2026-08-05 | Warnings, Adverse reactions | M007 |
| Metamucil Therapy for regularity | PSYLLIUM HUSK | Atlantic Biologicals Corp. | 57b112ea-f6b1-baa6-e063-6394a90a3b29 | 2026-08-05 | Warnings | M007 |
| MiraFAST soft chews | MAGNESIUM HYDROXIDE | Bayer HealthCare LLC. | 2cee67dd-b71f-32b8-e063-6394a90ae864 | 2026-08-05 | Warnings | M007 |
| MiraSOFT Stool Softener | DOCUSATE SODIUM | Bayer HealthCare LLC. | 5851f15f-8add-559f-e063-6394a90a7b7d | 2026-08-05 | Warnings | M007 |
| Stool Softener Laxative | DOCUSATE SODIUM | P & L Development, LLC | cbb0edf4-1fa7-42f5-a6f7-027e3961b50a | 2026-08-05 | 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 |