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 table| Ingredient | Strength |
|---|
| DOCUSATE SODIUM | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F05Q2T2JA0 |
| Rxcui | 1245468, 2692740 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67618-201 | COLACE EXTRA STRENGTH STOOL SOFTNER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [ATLANTIS CONSUMER HEALTHCARE INC.] | 3 | Current NDC, 3 package rows | 20250507_34e06b05-64a5-4b3e-af38-cdcd7c1d521b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 |