MiraLAX
- Product NDC
- 11523-4357
- 11-digit product format
- 115234357
- Labeler code
- 11523
- Product ID
- 11523-4357_51040c1b-71bf-bb83-e063-6294a90aca4e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polyethylene Glycol 3350
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- NDA022015
- Marketing category
- NDA
- Marketing start
- 2007-02-01
- 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
- MiraLAX
- 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, 876195 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11523-4357-1 | MiraLAX | 2 in 1 PACKAGE, COMBINATION | POWDER, FOR SOLUTION | 2 | | 24 |
| 11523-4357-1 | MiraLAX | 765 g in 1 BOTTLE, PLASTIC | POWDER, FOR SOLUTION | 765 | | 24 |
| 11523-4357-2 | MiraLAX | 20 in 1 CARTON | POWDER, FOR SOLUTION | 20 | | 24 |
| 11523-4357-2 | MiraLAX | 2 in 1 CARTON | POWDER, FOR SOLUTION | 2 | | 24 |
| 11523-4357-3 | MiraLAX | 2 in 1 PACKAGE, COMBINATION | POWDER, FOR SOLUTION | 2 | | 24 |
| 11523-4357-3 | MiraLAX | 578 g in 1 BOTTLE, PLASTIC | POWDER, FOR SOLUTION | 578 | | 24 |
| 11523-4357-5 | MiraLAX | 17 g in 1 PACKET | POWDER, FOR SOLUTION | 17 | | 24 |
| 11523-4357-5 | MiraLAX | 24 in 1 CARTON | POWDER, FOR SOLUTION | 24 | | 24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11523-4357 | MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.] | 22 | Current NDC, Legacy NDC, 8 package rows | 20241208_d69ce3d4-7ca4-4fe3-b49e-6655e48d6963.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 11523-4357-1 | 11523435701 | 2 in 1 PACKAGE, COMBINATION | | | | | | Historical |
| 11523-4357-2 | 11523435702 | 2 CARTON in 1 CARTON (11523-4357-2) / 20 PACKET in 1 CARTON / 17 g in 1 PACKET | 2 carton | 2007-02-01 | 0000-00-00 | No | No | Current |
| 11523-4357-3 | 11523435703 | 2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (11523-4357-3) / 578 g in 1 BOTTLE, PLASTIC | | 2007-02-01 | 0000-00-00 | No | No | Current |
| 11523-4357-5 | 11523435705 | 24 PACKET in 1 CARTON (11523-4357-5) / 17 g in 1 PACKET | 24 packet | 2018-05-01 | 0000-00-00 | Yes | No | Current |