Home NDC 11523-7268 MiraLAX
Product NDC 11523-7268
11-digit product format 115237268
Labeler code 11523
Product ID 11523-7268_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 NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded package package 11523-7268 11523-7268-7 D Discontinued by firm 2026-07-31
Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022015-001 MIRALAX POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL RLD, RS 2006-10-06 N022015-002 MIRALAX POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL RLD, RS 2006-10-06
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MiraLAX POLYETHYLENE GLYCOL 3350 Bayer HealthCare LLC. d69ce3d4-7ca4-4fe3-b49e-6655e48d6963 2026-05-04 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Allergy alert Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have nausea, vomiting or abdominal pain a sudden change in bowel habits that lasts over 2 weeks irritable bowel syndrome Ask a doctor of pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if you have rectal bleeding or you nausea, bloating or cramping or abdominal pain gets worse. These may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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 11523-7268-3 MiraLAX 10 in 1 CARTON POWDER, FOR SOLUTION 10 24 11523-7268-3 MiraLAX 17 g in 1 PACKET POWDER, FOR SOLUTION 17 24 11523-7268-4 MiraLAX 765 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 765 24 11523-7268-5 MiraLAX 850 g in 1 BOTTLE, PLASTIC POWDER, FOR SOLUTION 850 24 11523-7268-7 MiraLAX 5 in 1 CARTON POWDER, FOR SOLUTION 5 24 11523-7268-7 MiraLAX 17 g in 1 PACKET POWDER, FOR SOLUTION 17 24 11523-7268-8 MiraLAX 17 g in 1 PACKET POWDER, FOR SOLUTION 17 24 11523-7268-8 MiraLAX 24 in 1 CARTON POWDER, FOR SOLUTION 24 24 11523-7268-9 MiraLAX 20 in 1 CARTON POWDER, FOR SOLUTION 20 24 11523-7268-9 MiraLAX 17 g in 1 POUCH POWDER, FOR SOLUTION 17 24
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-7268 MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.] 22 Current NDC, Legacy NDC, 10 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 11523-7268-3 11523726803 10 PACKET in 1 CARTON (11523-7268-3) / 17 g in 1 PACKET 10 packet 2007-02-01 0000-00-00 No No Current 11523-7268-4 11523726804 765 g in 1 BOTTLE, PLASTIC (11523-7268-4) 765 g 2007-02-01 0000-00-00 No No Current 11523-7268-5 11523726805 850 g in 1 BOTTLE, PLASTIC (11523-7268-5) 850 g 2025-05-30 No No Current 11523-7268-7 11523726807 5 in 1 CARTON Historical 11523-7268-8 11523726808 24 PACKET in 1 CARTON (11523-7268-8) / 17 g in 1 PACKET 24 packet 2007-02-01 0000-00-00 No No Current 11523-7268-9 11523726809 20 POUCH in 1 CARTON (11523-7268-9) / 17 g in 1 POUCH 20 pouch 2007-02-01 0000-00-00 No No Current