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OneLAX Saline Laxative Magnesium Citrate 1.745 g/29.6mL Liquid, 296 mL — NDC 71399-0051-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

OneLAX Saline Laxative Magnesium Citrate 1.745 g/29.6mL Liquid, 296 mL — NDC 71399-0051-1 (Billing 71399-0051-01)

by AKRON PHARMA INC · 296 mL in 1 BOTTLE

This is a package of 296 mL of OneLAX Saline Laxative Magnesium Citrate 1.745 g/29.6mL Liquid from AKRON PHARMA INC, marketed since Aug 2023 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 71399-0051-01
🏷️ FDA NDC (as labeled) 71399-0051-1 billing pads the package segment with a zero
This package
Contains296 mL Medicaid pays$0.0101 / unit · 12 mo Per package$2.99 / 296 ml · Medicaid Pack sizes3 compare ↓
Main listing for product 71399-0051 · Also comes in: 12 bottles 71399-0051-2 296 ml 71399-0051-3
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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 71399-0051-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
71399 labeler · 0051 product · 1 package
Package marketed since
Aug 4, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
296 mL per package
Barcode (UPC)
0371399005113
Medicaid fills, this package
37 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026
⚠️
Other active recalls for Magnesium Citrate (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 1, 2024 — Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria (Pharma Nobis LLC) · FDA recall D-0501-2024
Class II · Dec 21, 2023 — MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. (Pharma Nobis LLC) · FDA recall D-0227-2024
Class II · Dec 21, 2023 — MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria. (Pharma Nobis LLC) · FDA recall D-0228-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71399-0051-1
Product NDC 71399-0051
11-digit billing NDC 71399005101
NCPDP billing unit ML — per mL (volume)
RxCUI 1052760
UNII RHO26O1T9V
UPC 0371399005113
Application # M007
SPL Set ID 44c87bbc-2507-4b87-a74b-02f4acb30cf4
Established class (EPC) Calculi Dissolution Agent; Osmotic Activity
Mechanism of action Magnesium Ion Exchange Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption; Inhibition Small Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-08-04
Route ORAL
Dosage form LIQUID
Substance MAGNESIUM CITRATE

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

GCN Seq No 003025
GCN 09240
HICL code 001328
Ingredient (HICL) Magnesium Citrate
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 ONELAX MAGNESIUM CITRATE SOLN
FDB brand name Onelax Magnesium Citrate
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 003025
  • GCN: 09240
  • HICL (First Databank): 001328
  • AHFS class code: 56:12.00.00
  • RxCUI (RxNorm): 1052760
Why two NDCs? The FDA registers this code as 71399-0051-1 — 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 → 71399-0051-01. 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 Osmotically acting laxatives class.

Drug family (ATC) Osmotically acting laxatives, Magnesium, Salt solutions
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 ONELAX MAGNESIUM CITRATE SOLN Ingredient Magnesium Citrate
📗 Our plain-language guide HelloPharmacist
  • It relieves occasional constipation. The labels say it generally produces a bowel movement within ½ to 6 hours, so plan to be near a bathroom.
  • Shake it well if the label says to, then drink the amount your label lists for your age. Follow it with a full 8-ounce glass of liquid. You can take it as one dose or split it, but...
  • Space them out. Take magnesium citrate at least 2 hours before or after your other drugs, because laxatives can change how other medicines work. Ask me or your doctor if you’re uns...
  • Talk to a doctor first if you have kidney disease, are on a magnesium-restricted diet, or have belly pain, nausea or vomiting. Also check in if your bowel habits suddenly changed f...
📖 Read our full Magnesium Citrate 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 $0.0101 $2.99 / 296 ml
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 Marketing startMarketing endStatus
71399-0051-03 71399-0051-3 296 mL in 1 BOTTLE 2023-08-04 — Active
71399-0051-01 You're viewing this Main listing 296 mL in 1 BOTTLE 2023-08-04 — Active
71399-0051-02 71399-0051-2 12 BOTTLE in 1 PACKAGE / 296 mL in 1 BOTTLE 2023-08-04 — Active

Pack size FAQ

What quantity is in this package?
This package contains 296 mL — 296 ml in 1 bottle.
How does this package differ from NDC 71399-0051-03?
Both are OneLAX Saline Laxative Magnesium Citrate 1.745 g/29.6mL Liquid — the drug itself is identical. This page's package is the 296 mL one, while NDC 71399-0051-03 is the 296 ml package.
What NDC number is used to bill for this package of OneLAX Saline Laxative Magnesium Citrate 1.745 g/29.6mL Liquid?
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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Magnesium Citrate 1.745 g/29.6mL 00904-7418-44 Major 296 ml $0.007 — Availability likely —
Magnesium Citrate 1.745 g/29.6mL 46122-0740-38 AMERISOURCE 296 ml $0.007 — Availability likely —
Magnesium Citrate 1.745 g/29.6mL 46122-0741-38 AMERISOURCE 296 ml $0.007 — Availability likely —
Magnesium Citrate 1.745 g/29.6mL 70000-0659-01 CARDINAL 296 ml $0.007 — Availability likely —
Magnesium Citrate 1.745 g/29.6mL 70000-0660-01 CARDINAL 296 ml $0.007 — Availability likely —
Magnesium Citrate 1.745 g/29.6mL 70000-0661-01 CARDINAL 296 ml $0.007 — Availability likely —
Magnesium Citrate 1.745 g/29.6mL 70677-1111-01 STRATEGIC 296 ml $0.007 — Availability likely —
Magnesium Citrate 1.745 g/29.6mL 70677-1112-01 STRATEGIC 296 ml $0.007 — Availability likely —
Magnesium Citrate Saline Laxative 1.745 g/29.6mL 82568-0051-01 AARNA 296 ml $0.007 — Availability likely —
Magnesium Citrate 1.745 g/29.6mL 00363-0415-98 WALGREEN 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 00363-0416-98 WALGREEN 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 00363-0427-98 WALGREEN 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 00869-0164-38 Vi-Jon, 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 11822-4303-02 Rite 296 ml — — Discontinued —
Magnesium Citrate 1.745 g/29.6mL 30142-0164-38 The 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 30142-0899-38 The 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 36800-0709-38 Topco 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 42507-0249-38 Hy-Vee, 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 50804-0164-38 Perrigo 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 50804-0166-38 Perrigo 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 51316-0880-10 CVS 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 51316-0881-10 CVS 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 51316-0882-10 CVS 296 ml — — FDA listed —
Magnesium Citrate Saline Laxative - Lemon Flavor .059 g/mL 52000-0449-10 Universal 296 ml — — FDA listed —
Magnesium Citrate Saline Laxative - Grape Flavor .059 g/mL 52000-0450-10 Universal 296 ml — — FDA listed —
Magnesium Citrate Saline Laxative - Cherry Flavor .059 g/mL 52000-0451-10 Universal 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 56062-0264-38 Publix 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 56062-0266-38 Publix 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 57896-0266-10 Geri-Care 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 63941-0162-38 Valu 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 69256-0311-10 Harris 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 69452-0389-98 Bionpharma, 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 69452-0390-98 Bionpharma, 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 69452-0391-98 Bionpharma, 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 69452-0398-98 Bionpharma, 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 69842-0763-38 CVS 296 ml — — FDA listed —
OneLAX Saline Laxative 1.745 g/29.6mLthis 71399-0051-01 AKRON 296 ml — — FDA listed —
OneLAX Saline Laxative 1.745 g/29.6mL 71399-0053-01 AKRON 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 79481-0032-09 Meijer 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 79481-0033-09 Meijer 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 79481-0034-09 Meijer 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 79903-0408-10 Walmart 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 79903-0409-10 Walmart 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 79903-0410-10 Walmart 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 82645-0310-10 Pharma 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 82645-0311-10 Pharma 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 82645-0312-10 Pharma 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 83324-0169-10 Chain 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 83324-0170-10 Chain 296 ml — — FDA listed —
Citroma 1.745 g/29.6mL 83986-0162-38 UpLift 296 ml — — FDA listed —
Citroma 1.745 g/29.6mL 83986-0164-38 UpLift 296 ml — — FDA listed —
Citroma 1.745 g/29.6mL 83986-0166-38 UpLift 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 85786-0503-10 Farmacias 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 87251-0001-01 4 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 87438-0002-00 Pinnacle 296 ml — — FDA listed —
Citroma 1.745 g/29.6mL 11344-0164-38 Nice-Pak 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 11673-0708-38 Target 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 72476-0002-38 Retail 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 41163-0709-38 United 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 72476-0001-38 Retail 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 21130-0165-38 Better 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 21130-0709-38 Better 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 55910-0183-38 Old 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 63941-0533-38 Valu 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 63868-0929-38 Chain 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 55910-0615-38 Old 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 63868-0018-38 Chain 296 ml — — FDA listed —
Citroma 1.745 g/29.6mL 11344-0162-38 Nice-Pak 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 11344-0166-38 Nice-Pak 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 41163-0769-38 United 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 55319-0164-38 Family 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 55910-0961-38 Old 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 69842-0647-38 CVS 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 69842-0983-38 CVS 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 53943-0166-38 Discount 296 ml — — FDA listed —
citroma 1.745 g/29.6mL 55319-0666-38 Family 296 ml — — FDA listed —
Magnesium Citrate 1.745 g/29.6mL 83324-0043-10 Chain 296 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where 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

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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

FlavorLemon
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.

🧪 Avoiding an ingredient? See Magnesium Citrate inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII X045WJ989B
    Sorbic acid is a preservative derived from berries that prevents mold, yeast, and bacterial growth in medicines. It keeps the product stable and safe during storage.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescitric acid, disodium edetate, lemon flavor, purified water, saccharin sodium, sorbic acid, sodium benzoate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerAKRON PHARMA INC
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code71399
First marketedAug 2023
Product typeHuman Otc Drug
Portfolio15 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 14 words ▾

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours

⏱️ Dosage and Administration 62 words ▾

Directions drink a full glass (8 ounces) of liquid with each dose. may be taken as a single daily dose or in divided doses. adults and children 12 years of age and over 1/2 bottle to 1 bottle (10 fl oz) children 6 to 11 years of age 1/3 bottle to 1/2 bottle children under 6 years of age consult a doctor

⚠️ Warnings 141 words ▾

Warnings Do not use laxative products for longer than 1 week unless directed by a doctor. Ask a doctor before use if you have kidney disease a magnesium restricted diet a sodium restricted diet stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more than 1 week Ask a doctor or pharmacist before use if you are presently taking a prescription drug. When using this product do not exceed the maximum recommended daily dosage in a 24 hour period.

Stop use and ask a doctor if you have rectal bleeding or no bowel movement after use. These could be signs of a serious condition. 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 (1-800-222-1222) right away.

🧪 Active Ingredient 10 words ▾

Active ingredient (30ml (approx. 1 Fl. oz)) Magnesium citrate 1.745g

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients citric acid, disodium edetate, lemon flavor, purified water, saccharin sodium, sorbic acid, sodium benzoate

🎯 Purpose 3 words ▾

Purpose Saline laxative

📄 Do Not Use 15 words ▾

Do not use laxative products for longer than 1 week unless directed by a doctor.

📄 Ask a Doctor Before Use If 36 words ▾

Ask a doctor before use if you have kidney disease a magnesium restricted diet a sodium restricted diet stomach pain, nausea or vomiting noticed a sudden change in bowel habits that lasts more than 1 week

📄 Ask a Doctor or Pharmacist Before Use If 15 words ▾

Ask a doctor or pharmacist before use if you are presently taking a prescription drug.

📄 When Using This Product 17 words ▾

When using this product do not exceed the maximum recommended daily dosage in a 24 hour period.

📄 Stop Use and Ask a Doctor If 25 words ▾

Stop use and ask a doctor if you have rectal bleeding or no bowel movement after use. These could be signs of a serious condition.

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

📄 Questions or Comments 14 words ▾

Questions or comments? Call toll-free 1-877-225-6999. Manufactured for: Akron Pharma Inc., Fairfield, NJ-07004 www.akronpharma.com

📄 Package Label / Principal Display Panel 6 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL 1

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.
📅 Q1 2025 – Q4 2025 · 2 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
37
Units reimbursed last 4 qtrs
13.6K
Gross reimbursed last 4 qtrs
$138.11
Avg / prescription
$3.73
Avg / unit
$0.0101
Latest quarter Q4 2025
18Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 37 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: 13,616 units · 237 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported 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: no data reported 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
237237
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 Minnesota 237 /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.
296 ml71399-0051-03 No Medicaid data
12 bottles71399-0051-02 No Medicaid data
Drug total (last 4 qtrs): 37 Rx · 13,616 units · $138 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 OneLAX Saline Laxative (this brand).

Top reported reactions

Fatigue820
Nausea813
Pain754
Diarrhoea731
Headache670
Asthenia579
Dizziness574

Age at onset

Neonate31
Infant4
Child18
Adolescent15
Adult593
Elderly458

Reporter sex

5,984 reports
Male · 28%
Female · 72%
Unknown · 0%

Serious outcomes

Hospitalization2,243
Disabling1,023
Death1,020
Life-threatening971
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 682 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) ✓ 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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 AKRON PHARMA 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 2 other package presentations of this same product, including 12 bottles (71399-0051-02), 296 ml (71399-0051-03). 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?
AKRON PHARMA 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.