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MiraLAX Polyethylene Glycol 3350 3350 17 g/17g Powder, For Solution — NDC 11523-7268-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

MiraLAX Polyethylene Glycol 3350 3350 17 g/17g Powder, For Solution — NDC 11523-7268-3 (Billing 11523-7268-03) · Product 11523-7268

by Bayer HealthCare LLC. · 10 PACKET in 1 CARTON (11523-7268-3) / 17 g in 1 PACKET

NDC 11523-7268-3 (billing 11523-7268-03) is a package of MiraLAX Polyethylene Glycol 3350 3350 17 g/17g Powder, For Solution from Bayer HealthCare LLC., marketed since Feb 2007 and currently FDA-listed. It is the main listing for product NDC 11523-7268, which comes in 5 package sizes.

NDC 11523-7268-03
🏷️ FDA NDC (as labeled) 11523-7268-3 billing pads the package segment with a zero
This package
Contains17 g in 1 packet Pack sizes5 compare ↓
Main listing for product 11523-7268 · Also comes in: 20 pouches 11523-7268-9 24 packets 11523-7268-8 765 g 11523-7268-4 850 g 11523-7268-5
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Past resolved recalls for this product (1)
Class II · Jun 29, 2022 · Terminated — CGMP Deviations: products were stored outside the drug label specifications. (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1319-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11523-7268-3
Product NDC 11523-7268
11-digit billing NDC 11523726803
NCPDP billing unit EA — each (per item)
RxCUI 876193, 876195
UNII G2M7P15E5P
UPC 0041100820716, 0041100564542
Application # NDA022015
SPL Set ID d69ce3d4-7ca4-4fe3-b49e-6655e48d6963
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Stimulation Large Intestine Fluid/Electrolyte Secretion
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-02-01
Route ORAL
Dosage form POWDER, FOR SOLUTION
Substance POLYETHYLENE GLYCOL 3350

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 46600033002910
GPI class MiraLax
GCN Seq No 034313
GCN 86211
HICL code 022819
Ingredient (HICL) Polyethylene Glycol 3350
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6S
Therapeutic class — specific (HIC3) Laxatives And Cathartics
AHFS code 56:12.00.00
AHFS class Cathartics And Laxatives
FDB label name MIRALAX POWDER PACKET
FDB brand name Miralax
Legend status O — Over-the-counter (OTC) drug or device
Quick answers for NDC 11523-7268-3
  • GSN (GCN sequence number): 034313
  • GCN: 86211
  • GPI-14 (Medi-Span): 46600033002910
  • HICL (First Databank): 022819
  • AHFS class code: 56:12.00.00
  • RxCUI (RxNorm): 876193
  • 11-digit billing NDC: 11523726803
Why two NDCs? The FDA registers this code as 11523-7268-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 11523-7268-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Osmotic Laxative class.

Pharmacologic class Osmotic Laxative
How it works Osmotic Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name MIRALAX POWDER PACKET Ingredient Polyethylene Glycol 3350
📖 What it is MedlinePlus · NLM

Polyethylene glycol 3350 is used to treat occasional constipation. Polyethylene glycol 3350 is in a class of medications called osmotic laxatives. It works by causing water to be retained with the stool. This increases the number of bowel movements and softens the stool so it is easier to pass.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • You can generally expect a bowel movement within 1 to 3 days after taking it. It's not meant to work in an hour like some other laxatives — it works gradually. If you haven't gone...
  • How long does it take for Polyethylene Glycol 3350 to work?
  • You can stir it into any 4 to 8 ounces of beverage — water, juice, coffee, tea, whatever you like, cold or hot. The key is to stir it well until it's completely dissolved. Don't dr...
  • Can I mix it into any drink, or does it have to be water?
📖 Read our full Polyethylene Glycol 3350 guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 20 pouches 24 packets 765 g 850 g
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
11523-7268-03 11523-7268-3 You're viewing this Main listing 10 PACKET in 1 CARTON (11523-7268-3) / 17 g in 1 PACKET 2007-02-01 — Active
11523-7268-04 11523-7268-4 765 g in 1 BOTTLE, PLASTIC (11523-7268-4) 2007-02-01 — Active
11523-7268-08 11523-7268-8 24 PACKET in 1 CARTON (11523-7268-8) / 17 g in 1 PACKET 2007-02-01 — Active
11523-7268-09 11523-7268-9 20 POUCH in 1 CARTON (11523-7268-9) / 17 g in 1 POUCH 2007-02-01 — Active
11523-7268-05 11523-7268-5 850 g in 1 BOTTLE, PLASTIC (11523-7268-5) 2025-05-30 — Active

Pack size FAQ

What quantity is in NDC 11523-7268-03?
NDC 11523-7268-03 is listed by the FDA — 10 packet in 1 carton / 17 g in 1 packet.
What NDC number is used to bill for this package of MiraLAX Polyethylene Glycol 3350 3350 17 g/17g Powder, For Solution?
Bill NDC 11523-7268-03 — the 11-digit billing format is 11523726803. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Polyethylene Glycol 3350 3350 17 g/17g 51672-2104-03 Sun 765 g $0.014 — Availability likely —
rugby PEG 3350 3350 17 g/17g 00536-1052-24 Rugby 238 g $0.024 — Availability likely —
good neighbor pharmacy clearlax 3350 17 g/17g 46122-0805-29 Amerisource 238 g $0.024 — Availability likely —
Polyethylene Glycol 3350 17 g/17g 68001-0505-55 BluePoint 238 g $0.024 — Availability likely —
Polyethylene Glycol 3350 3350 17 g/17g 68001-0607-55 BluePoint 238 g $0.024 — Availability likely —
Leader ClearLax 3350 17 g/17g 70000-0704-01 Cardinal 238 g $0.024 — Availability likely —
Polyethylene Glycol 3350 3350 17 g/17g 83324-0002-08 CHAIN 238 g $0.024 — Availability likely —
Polyethylene Glycol 3350, NF Powder for Solution, Laxative 3350 17 g/d 45861-0083-05 Pharmaceutica 238 ds $0.024 — Availability likely —
Clearlax 3350 17 g/17g 70677-1068-01 STRATEGIC 238 g $0.024 — Availability likely —
Good Sense Clear Lax 3350 17 g/17g 00113-0306-01 L. 119 g $0.029 — Availability likely —
Polyethylene Glycol 3350 3350 17 g/17g 45802-0868-01 Padagis 119 g $0.029 — Availability likely —
Good Neighbor Pharmacy ClearLax 3350 17 g/17g 46122-0014-31 Amerisource 119 g $0.029 — Availability likely —
leader clearlax 3350 17 g/17g 70000-0415-01 Cardinal 119 g $0.029 — Availability likely —
foster and thrive clearlax 3350 17 g/17g 70677-1109-01 Strategic 119 g $0.029 — Availability likely —
Polyethylene Glycol 3350 3350 17 g/17g 63739-0760-02 SKY 14 packets $1.127 — Discontinued —
Polyethylene glycol 3350 3350 17 g/17g 00904-6931-26 Major 14 packets $1.224 — Availability likely —
Polyethylene Glycol (3350) 3500 17 g/17g 51079-0306-30 Mylan 30 pouches $1.224 — Availability likely —
Polyethylene Glycol 3350 3350 17 g/17g 62559-0157-10 ANI 100 packets $1.224 — Availability likely —
Polyethylene Glycol 3350 3350 17 g/17g 72603-0302-02 NorthStar 14 packets $1.224 — Availability likely —
Polyethylene Glycol 3350 3350 17 g/17g 81033-0762-01 Kesin 100 packets $1.224 — Availability likely —
Polyethylene Glycol 3350 3350 17 g/17g 60687-0431-92 American 100 pouches $1.224 — Availability likely —
good sense clearlax 3350 17 g/17g 00113-1023-03 L. 510 g — — FDA listed —
injoy constipation relief 3350 17 g/17g 00113-6900-02 L. 1 bottle — — FDA listed —
smooth lax 3350 17 g/17g 00363-0306-00 Walgreen 17 g — — FDA listed —
smoothlax 3350 17 g/17g 00363-1323-03 Walgreen 510 g — — FDA listed —
Walgreens 3350 17 g/17g 00363-5260-07 WALGREEN 119 g — — FDA listed —
MiraLAX Orange Flavor 3350 17 g/17g 11523-0122-01 Bayer 238 g — — FDA listed —
MiraLAX 3350 17 g/17g 11523-4357-02 Bayer 20 packets — — FDA listed —
MiraLAX 3350 17 g/17g 11523-7234-01 Bayer 17 g — — Discontinued —
MiraLAX 3350 17 g/17gthis 11523-7268-03 Bayer 10 packets — — FDA listed —
MiraLAX 3350 17 g/17g 11523-7341-01 Bayer 612 g — — Discontinued —
Polyethylene Glycol 3350 Nf 3350 17 g/17g 11534-0180-19 SUNRISE 119 g — — FDA listed —
up and up powderlax 3350 17 g/17g 11673-0306-01 Target 119 g — — FDA listed —
Laxative 3350 17 g/17g 11822-0306-03 Rite 119 g — — FDA listed —
laxative 3350 17 g/17g 11822-1199-00 Rite 238 g — — FDA listed —
Gavilax 3350 17 g/17g 17856-0310-01 Atlantic 50 cups — — FDA listed —
Gavilax 3350 17 g/17g 17856-0312-01 ATLANTIC 17 g — — FDA listed —
Clearlax 3350 17 g/17g 21130-0637-02 Safeway 238 g — — FDA listed —
signature care clearlax 3350 17 g/17g 21130-0847-01 Safeway 119 g — — FDA listed —
gentle lax 3350 17 g/17g 30142-0306-01 Kroger 119 g — — FDA listed —
Gentlelax 3350 17 g/17g 30142-0504-02 Kroger 238 g — — FDA listed —
Kroger 3350 17 g/17g 30142-0526-07 KROGER 119 g — — FDA listed —
Topcare ClearLax 3350 17 g/17g 36800-0306-01 Topco 119 g — — FDA listed —
clear lax 3350 17 g/17g 37808-0306-01 H 119 g — — FDA listed —
equaline clearlax 3350 17 g/17g 41163-0306-01 United 119 g — — FDA listed —
Dulcolax 3350 17 g/17g 41167-0223-00 Chattem, 765 g — — FDA listed —
clear lax 3350 17 g/17g 41250-0306-01 Meijer 119 g — — FDA listed —
care one clearlax 3350 17 g/17g 41520-0306-01 American 119 g — — FDA listed —
clear lax 3350 17 g/17g 42507-0306-01 HyVee 119 g — — FDA listed —
365 WHOLE FOODS MARKET Polyethylene Glycol 3350 3350 17 g/17g 42681-0059-01 Whole 119 g — — FDA listed —
Gavilax 3350 17 g/17g 43386-0312-07 Lupin 119 g — — FDA listed —
equate clear lax 3350 17 g/17g 49035-0306-01 Wal-Mart 119 g — — FDA listed —
Mix-In Laxative Packets 3350 17 g/17g 49035-0906-03 Wal-Mart 10 packets — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 50090-2430-00 A-S 238 g — — FDA listed —
Gavilax 3350 17 g/17g 50090-5310-00 A-S 238 g — — FDA listed —
Discount Drug Mart 3350 17 g/17g 53943-0652-14 DISCOUNT 238 g — — FDA listed —
Polyethylene glycol 3350 3350 17 g/17g 55154-2328-05 Cardinal 7 packets — — FDA listed —
MiraLAX 3350 17 g/17g 55154-5035-06 Cardinal 6 packets — — FDA listed —
Polyethylene glycol 3350 3350 17 g/17g 55154-8090-05 Cardinal 5 pouches — — FDA listed —
Polyethylene glycol 3350 3350 17 g/17g 55154-8091-05 Cardinal 5 pouches — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 55154-8184-05 Cardinal 7 pouches — — FDA listed —
Exchange Select ClearLax 3350 17 g/17g 55301-0306-03 Army 510 g — — FDA listed —
Comfortlax 3350 17 g/17g 55319-0056-24 Family 119 g — — FDA listed —
dg health clearlax 3350 17 g/17g 55910-0306-01 Dolgencorp, 119 g — — FDA listed —
dg health clearlax 3350 17 g/17g 55910-0846-02 Dolgencorp 238 g — — FDA listed —
clearlax 3350 17 g/17g 56062-0306-02 Publix 238 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 57896-0489-14 Geri-Care 238 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 57896-0490-03 Gericare 30 packets — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 58602-0805-01 Aurohealth 119 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 59556-0762-01 Strides 10 packets — — Discontinued —
clearlax 3350 17 g/17g 59640-0797-02 H 238 g — — FDA listed —
purelax 3350 17 g/17g 59779-0306-01 CVS 119 g — — FDA listed —
Gavilax 3350 17 g/17g 63187-0368-23 Proficient 238 g — — FDA listed —
EasyLAX 3350 17 g/17g 63941-0489-14 VALU 238 g — — FDA listed —
kirkland signature laxaclear original prescription strength 3350 17 g/17g 63981-0306-04 Costco 850 g — — FDA listed —
Welby ClearLax 3350 17 g/17g 64024-0306-02 Aldi, 238 g — — FDA listed —
Winco 3350 17 g/17g 67091-0447-08 WINCO 238 g — — FDA listed —
Members Mark clearlax 3350 17 g/17g 68196-0306-07 Sam's 3 bottles — — FDA listed —
berkley and jensen clearlax 3350 17 g/17g 68391-0306-02 BJWC 765 g — — FDA listed —
Gavilax 3350 17 g/17g 68788-7508-02 Preferred 238 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 68788-8601-02 Preferred 238 g — — FDA listed —
Good Sense Clear Lax 3350 17 g/17g 68788-8795-02 Preferred 238 g — — FDA listed —
Polyethylene Gycol 3350 3350 17 g/g 69168-0473-55 Allegiant 510 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 69230-0324-32 Camber 7 packets — — FDA listed —
purelax 3350 17 g/17g 69842-0458-01 CVS 119 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 70000-0699-02 CARDINAL 10 packets — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 72090-0036-01 PIONEER 30 packets — — FDA listed —
rugby PEG 3350 3350 17 g/17g 72162-2155-02 Bryant 238 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 72162-2172-02 Bryant 238 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 72162-2180-02 Bryant 238 g — — FDA listed —
basic care clearlax 3350 17 g/17g 72288-0020-02 Amazon.com 238 g — — FDA listed —
basic care clearlax 3350 17 g/17g 72288-0499-02 Amazon.com 238 g — — FDA listed —
careone clearlax 3350 17 g/17g 72476-0723-03 Retail 510 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 72657-0196-16 GLENMARK 765 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g 73581-0913-40 YYBA 40 packets — — FDA listed —
Topcare ClearLax 3350 17 g/17g 76162-0119-02 Topco 238 g — — FDA listed —
MiraLAX 3350 17 g/17g 76420-0489-10 ASCLEMED 10 packets — — FDA listed —
ez2go Polyethylene Glycol 3350 3350 17 g/17g 76470-0050-50 Valley 119 g — — FDA listed —
Polyethylene Glycol 3350 Powder for Solution 3350 17 g/17g 76470-0069-69 VALLEY 238 g — — FDA listed —
clearlax 3350 17 g/17g 79481-0090-03 Meijer, 510 g — — FDA listed —
Polyethylene Glycol 3350, NF Powder for Solution, Laxative 3350 17 g/d 79739-7116-01 LGM 7 ds — — FDA listed —
Equate ClearLAX 3350 17 g/17g 79903-0114-14 WALMART 238 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 84386-0125-08 Aurobindo 119 g — — FDA listed —
Good Sense Clear Lax 3350 17 g/17g 71205-0447-38 Proficient 238 g — — FDA listed —
Clearlax 3350 17 g/17g 72288-0033-03 Amazon.com 510 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 87362-0119-01 The 119 g — — FDA listed —
Peg3350 3350 17 g/17g 00904-7534-26 Major 15 packets — — FDA listed —
Clearlax 3350 17 g/17g 72288-0471-09 Amazon.com 765 g — — FDA listed —
Polyethylene Glycol 3350 3350 17 g/17g 50844-0772-01 L.N.K. 30 packets — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2007
On the market since
Feb 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

From the label’s inactive-ingredient sectionnone

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBayer HealthCare LLC.
Application holderBAYER HEALTHCARE LLC
FDA applicationNDA022015 (NDA)
Labeler code11523
First marketedFeb 2007
Product typeHuman Otc Drug
Portfolio240 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

Use relieves occasional constipation (irregularity) generally produces a bowel movement in 1 to 3 days

⏱️ Dosage and Administration ~1 min read ▾

Directions (Bottle Only) do not take more than directed unless advised by your doctor the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap) adults and children 17 years of age and older: use once a day fill to top of white section in cap which is marked to indicate the correct dose (17 g) stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink do not combine with starch-based thickeners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do not drink if there are any clumps do not use no more than 7 days children 16 years of age or under: ask a doctor

Directions (Packet Only) do not take more than directed unless advised by your doctor adults and children 17 years of age and older: use once a day stir and dissolve one packet of powder (17 g) in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink do not combine with starch-based thickeners used for difficulty swallowing ensure that the powder is fully dissolved before drinking do not drink if there are any clumps do not use more than 7 days children 16 years of age or under: ask a doctor

⚠️ Warnings 159 words ▾

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.

📦 Storage and Handling 26 words ▾

Other information store at 20°-25°C (68°-77°F) tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken

🧪 Active Ingredient 28 words ▾

Active ingredient (in each dose) (Bottle Only) Polyethylene Glycol 3350, 17 g (cap filled to line)

Active ingredient (in each dose) (Packet Only) Polyethylene Glycol 3350, 17 g

🧪 Inactive Ingredients 3 words ▾

Inactive ingredients none

🎯 Purpose 6 words ▾

Purpose Osmotic Laxative

Purpose Osmotic Laxative

📄 Do Not Use 17 words ▾

Do not use if you have kidney disease, except under the advice and supervision of a doctor

📄 Ask a Doctor Before Use If 27 words ▾

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 or Pharmacist Before Use If 14 words ▾

Ask a doctor of pharmacist before use if you are taking a prescription drug

📄 When Using This Product 12 words ▾

When using this product you may have loose, watery, more frequent stools

📄 Stop Use and Ask a Doctor If 44 words ▾

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 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 5 words ▾

Questions or comments? 1-800-MiraLAX (1-800-647-2529)

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 17 g × 20 Packet Carton 20 Single Doses #1 DOCTOR RECOMMENDED BRAND MiraLAX ® Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative Mix-In Pax ® Relieves Occasional Constipation/Irregularity Softens Stool 20 ONCE-DAILY DOSES Bayer Unflavored Powder Dissolves in ANY Beverage! UNFLAVORED POWDER GRIT FREE 20 PACKETS NET WT

0.5 OZ (17g) EACH 20ct Carton

PRINCIPAL DISPLAY PANEL - 17 g × 10 Packet Carton 10 Single Doses #1 DOCTOR RECOMMENDED BRAND MiraLAX ® Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative Mix-In Pax ® Relieves Occasional Constipation/Irregularity Softens Stool 10 ONCE-DAILY DOSES Bayer Unflavored Powder Dissolves in ANY Beverage! UNFLAVORED POWDER GRIT FREE 10 PACKETS NET WT

0.5 OZ (17g) EACH 10ct Carton

PRINCIPAL DISPLAY PANEL - 30 Dose (510 g) Bottle Label Easy to Pour Bottle #1 DOCTOR RECOMMENDED BRAND MiraLAX ® Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative UNFLAVORED POWDER GRIT FREE Relieves Occasional Constipation/Irregularity Softens Stool Bayer 30 ONCE-DAILY DOSES NET WT

17.9 OZ (510 g) 30 Front 30 Dose - Back

PRINCIPAL DISPLAY PANEL - Twinpack 2x34 Dose (578 g) Bottle Label Twin Pack! 2 x 34 Doses Easy to Pour Bottle MiraLAX ® Polyethylene Glycol 3350, Powder for Solution, Osmotic Laxative #1 DOCTOR RECOMMENDED BRAND Relieves Occasional Constipation/Irregularity Softens Stool UNFLAVORED POWDER GRIT FREE Bayer 34 ONCE-DAILY DOSES NET WT

20.4 OZ (578 g) 34 Dose Front 34 Dose Back

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for MiraLAX (this brand).

Top reported reactions

Diarrhoea6,780
Nausea5,095
Constipation4,916
Fatigue4,412
Vomiting3,089
Incorrect Drug Administration Duration2,828
Pain2,743

Age at onset

Neonate17
Infant171
Child1,369
Adolescent441
Adult9,881
Elderly14,774

Reporter sex

90,014 reports
Male · 39%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization19,541
Death5,666
Life-threatening1,785
Disabling1,480
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,756 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 11523-7268-3, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 11523-7268-03, written without dashes as 11523726803. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 11523-7268-03, the first segment (11523) is the labeler code FDA assigned to Bayer HealthCare LLC.; the middle segment (7268) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Bayer HealthCare LLC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 20 pouches (11523-7268-09), 24 packets (11523-7268-08), 765 g (11523-7268-04). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Bayer HealthCare LLC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 11523-7237-01 · Bayer 11523-7333-01 · Bayer →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.