Polyethylene Glycol 3350, NF Powder for Solution, Laxative 3350 17 g/d Powder, For Solution — NDC 45861-0083-06 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Polyethylene Glycol 3350, NF Powder for Solution, Laxative 3350 17 g/d Powder, For Solution — NDC 45861-083-06 (Billing 45861-0083-06)

by Pharmaceutica North America, Inc. · 2 BOTTLE in 1 BOX / 476 d in 1 BOTTLE

This is a package of Polyethylene Glycol 3350, NF Powder for Solution, Laxative 3350 17 g/d Powder, For Solution from Pharmaceutica North America, Inc., marketed since Feb 2025 and currently FDA-listed.

NDC 45861-0083-06
🏷️ FDA NDC (as labeled) 45861-083-06 billing pads the product segment with a zero
This package
Contains476 d in 1 bottle Medicaid pays$0.0957 / unit · 12 mo Pack sizes2 compare ↓
OTC Generic 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 →

NDC database record

One package, one record: these facts belong to NDC 45861-083-06 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
45861 labeler · 083 product · 06 package
Package marketed since
Feb 10, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4586108306 0
Medicaid fills, this package
5,734 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45861-083-06
Product NDC 45861-083
11-digit billing NDC 45861008306
NCPDP billing unit GM — per gram (weight)
RxCUI 876193
UNII G2M7P15E5P
Application # ANDA090812
SPL Set ID d048111f-8144-4d51-a0c2-a967b2bce455
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Stimulation Large Intestine Fluid/Electrolyte Secretion
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-10
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
GCN Seq No 041843
GCN 86212
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 POLYETHYLENE GLYCOL 3350 POWD
FDB brand name Polyethylene Glycol 3350
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 041843
  • GCN: 86212
  • GPI-14 (Medi-Span): 46600033002910
  • HICL (First Databank): 022819
  • AHFS class code: 56:12.00.00
  • RxCUI (RxNorm): 876193
Why two NDCs? The FDA registers this code as 45861-083-06 — a 5-3-2 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 product segment → 45861-0083-06. 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 POLYETHYLENE GLYCOL 3350 POWD 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 $0.0957 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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 Per unit Per pack Marketing startMarketing endStatus
45861-0083-05 45861-083-05 Main listing 238 d in 1 BOTTLE $0.0245 / g — 2025-02-10 — Active
45861-0083-06 You're viewing this 2 BOTTLE in 1 BOX / 476 d in 1 BOTTLE — — 2025-02-10 — Active

In Medicaid, this is the most-dispensed pack of this product — about 91% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 bottle in 1 box / 476 d in 1 bottle.
What NDC number is used to bill for this package of Polyethylene Glycol 3350, NF Powder for Solution, Laxative 3350 17 g/d Powder, For Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

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 —
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 —
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/17g 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 —
Polyethylene Glycol 3350, NF Powder for Solution, Laxative 3350 17 g/dthis 45861-0083-06 Pharmaceutica 2 bottles — — 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2025
On the market since
Feb 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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

LabelerPharmaceutica North America, Inc.
Application holderPOINTVIEW HOLDINGS LLC
FDA applicationANDA090812 (ANDA)
Labeler code45861
First marketedFeb 2025
Product typeHuman Otc Drug
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 15 words ▾

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

⏱️ Dosage and Administration 130 words ▾

Directions d o 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 the top of white section in cap which is marked to indicate the correct dose (17g) 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 more than 7 days children 16 years of age or under: ask a doctor

⚠️ Warnings 157 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 or 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 your nausea, bloating, 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 reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

🧪 Active Ingredient 16 words ▾

Active I ngredient (in each dose) Polyethylene Glycol 3350, 17 g (cap filled to the top)

🧪 Inactive Ingredients 3 words ▾

Inactive ingredients none

🎯 Purpose 3 words ▾

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 or 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 43 words ▾

Stop use and ask a doctor if: you have rectal bleeding, or your nausea, bloating, 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 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

📄 Questions or Comments 15 words ▾

Questions or c omments? 1-888-788-6472 Manufactured for : Pharmaceutica North America, Inc,, Glendale, CA 912050.

📄 Package Label / Principal Display Panel 6 words ▾

Product label image description image description

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q2 2025 – Q4 2025 · 3 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5.7K
Units reimbursed last 4 qtrs
2.3M
Gross reimbursed last 4 qtrs
$217.8K
Avg / prescription
$37.98
Avg / unit
$0.0957
Latest quarter Q4 2025
74Rx
Fee-for-service vs managed care ⓘ
99% FFS
Fee-for-service · 5,660 Rx Managed care · 74 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 33,320 units · 332 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 2,242,178 units · 5,754 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3325,754
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 5,754 /100k
2 Michigan 332 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
2 bottles this page45861-0083-06 5,734 Rx · $217,770
238 ds45861-0083-05 568 Rx · $10,890
Drug total (last 4 qtrs): 6,302 Rx · 2,440,207 units · $228,660 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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) ✓ Available
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Pharmaceutica North America, Inc.. 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 1 other package presentation of this same product, including 238 ds (45861-0083-05). 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?
Pharmaceutica North America, Inc. 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.
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.