MiraLAX Orange Flavor
- Product NDC
- 11523-0122
- 11-digit product format
- 115230122
- Labeler code
- 11523
- Product ID
- 11523-0122_4526ca58-f032-31ad-e063-6394a90a7bae
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polyethylene Glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- ANDA090685
- Marketing category
- ANDA
- Marketing start
- 2023-09-15
- 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
- MiraLAX Orange Flavor
- 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, 876195 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11523-0122-1 | MiraLAX Orange Flavor | 238 g in 1 BOTTLE | POWDER, FOR SOLUTION | 238 | | 3 |
| 11523-0122-2 | MiraLAX Orange Flavor | 119 g in 1 BOTTLE | POWDER, FOR SOLUTION | 119 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11523-0122 | MIRALAX ORANGE FLAVOR (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.] | 2 | Current NDC, 2 package rows | 20241208_0a5b2121-928f-8f49-e063-6394a90a8aaf.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 |
|---|
| 11523-0122-1 | 11523012201 | 238 g in 1 BOTTLE (11523-0122-1) | 238 g | 2023-09-15 | No | No | Current |
| 11523-0122-2 | 11523012202 | 119 g in 1 BOTTLE (11523-0122-2) | 119 g | 2023-09-15 | No | No | Current |