COMFORTLAX
- Product NDC
- 55319-056
- 11-digit product format
- 553190056
- Labeler code
- 55319
- Product ID
- 55319-056_92049a0c-1ad7-4741-b82f-93995f3b96a3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polyethylene Glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Family Dollar Stores, LLC
- Application
- ANDA209017
- Marketing category
- ANDA
- Marketing start
- 2024-09-04
- Substance
- POLYETHYLENE GLYCOL 3350
- Active strength
- 17 g/17g
- Pharmacologic classes
- Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- COMFORTLAX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POLYETHYLENE GLYCOL 3350 | 17 g/17g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G2M7P15E5P |
| Rxcui | 876193, 2695451 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55319-056-24 | COMFORTLAX | 119 g in 1 BOTTLE, PLASTIC | POWDER, FOR SOLUTION | 119 | | 4 |
| 55319-056-27 | COMFORTLAX | 510 g in 1 BOTTLE, PLASTIC | POWDER, FOR SOLUTION | 510 | | 4 |
| 55319-056-33 | COMFORTLAX | 238 g in 1 BOTTLE, PLASTIC | POWDER, FOR SOLUTION | 238 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55319-056 | COMFORTLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [FAMILY DOLLAR STORES, LLC] | 3 | Current NDC, 3 package rows | 20250327_02a44a41-0039-f6ec-e063-6394a90ae6f1.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 |
|---|
| 55319-056-24 | 55319005624 | 119 g in 1 BOTTLE, PLASTIC (55319-056-24) | 119 g | 2024-09-04 | No | No | Current |
| 55319-056-27 | 55319005627 | 510 g in 1 BOTTLE, PLASTIC (55319-056-27) | 510 g | 2024-09-04 | No | No | Current |
| 55319-056-33 | 55319005633 | 238 g in 1 BOTTLE, PLASTIC (55319-056-33) | 238 g | 2024-09-04 | No | No | Current |