GENTLELAX
- Product NDC
- 30142-504
- 11-digit product format
- 301420504
- Labeler code
- 30142
- Product ID
- 30142-504_e1f2a9bc-4f0c-4bf3-847f-e8a806c6856f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polyethylene Glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Kroger Company
- Application
- ANDA090685
- Marketing category
- ANDA
- Marketing start
- 2024-06-20
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- GENTLELAX
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POLYETHYLENE GLYCOL 3350 | 17 g/17g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G2M7P15E5P |
| Rxcui | 876193, 1049423 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 30142-504-02 | GENTLELAX | 238 g in 1 CONTAINER | POWDER, FOR SOLUTION | 238 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 30142-504 | GENTLELAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [KROGER COMPANY] | 2 | Current NDC, 1 package rows | 20240707_2390b507-93d5-43a0-aa51-31ca4edd6b7f.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 |
|---|
| 30142-504-02 | 30142050402 | 238 g in 1 CONTAINER (30142-504-02) | 238 g | 2024-06-20 | No | No | Historical |