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Laxomil Bisacodyl 5mg 5 mg Tablet, Coated, 24-count — NDC 55758-0504-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Laxomil Bisacodyl 5mg 5 mg Tablet, Coated, 24-count — NDC 55758-504-01 (Billing 55758-0504-01)

by Pharmadel LLC · 1 BLISTER PACK in 1 CARTON / 24 TABLET, COATED in 1 BLISTER PACK

This is a package of 24 tablets of Laxomil Bisacodyl 5mg 5 mg Tablet, Coated from Pharmadel LLC, marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 55758-0504-01
🏷️ FDA NDC (as labeled) 55758-504-01 billing pads the product segment with a zero
OTC 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55758-504-01
Product NDC 55758-504
11-digit billing NDC 55758050401
RxCUI 308753, 2719716
UNII 10X0709Y6I
Application # M007
SPL Set ID 3999935b-d8e8-52a6-e063-6294a90aa2a2
Established class (EPC) Stimulant Laxative
Physiologic effect Increased Large Intestinal Motility; Stimulation Large Intestine Fluid/Electrolyte Secretion
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-10
Route ORAL
Dosage form TABLET, COATED
Substance BISACODYL
Quick answers
  • RxCUI (RxNorm): 308753
Why two NDCs? The FDA registers this code as 55758-504-01 — 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 → 55758-0504-01. 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 Stimulant Laxative class.

Pharmacologic class Stimulant Laxative
Drug family (ATC) Contact laxatives, Enemas
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

📖 What it is MedlinePlus · NLM

Bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It relieves occasional constipation and irregularity. The Fleet enema is also used for fecal impaction and to clear residue after a barium test. It is meant for short-term use.
  • It depends on the form. Tablets usually work in 6 to 12 hours. Suppositories usually work in 15 minutes to 1 hour. The Fleet enema usually works in 5 to 20 minutes.
  • Not right away. Wait at least 1 hour after an antacid or milk before taking tablets. Swallow tablets whole with water and do not chew or crush them.
  • Can I take the tablets with an antacid or milk?
📖 Read our full Bisacodyl guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 eachPer 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.
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
55758-0504-01 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 24 TABLET, COATED in 1 BLISTER PACK 2025-07-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bisacodyl 5 mg 00904-6407-61 Major 10 tablets $0.044 — Availability likely —
Bisacodyl 5 mg 00904-6748-17 Major 25 tablets $0.044 — Availability likely —
Womens Gentle Laxative 5 mg 46122-0429-63 Amerisource 25 tablets $0.044 — Availability likely —
Gentle Laxative 5 mg 46122-0529-63 Amerisource 25 tablets $0.044 — Availability likely —
Gentle Laxative 5 mg 46122-0767-11 Amerisource 25 tablets $0.044 — Availability likely —
Gentle Laxative 5 mg 70000-0221-01 Cardinal 10 tablets $0.044 — Availability likely —
Gentle Laxative 5 mg 70000-0538-01 CARDINAL 100 tablets $0.044 — Availability likely —
Laxative 5 mg 70677-1086-01 Strategic 10 tablets $0.044 — Availability likely —
Gentle Laxative 5 mg 83324-0033-30 Chain 15 tablets $0.044 — Availability likely —
Laxative 5 mg 83324-0061-30 Chain 25 tablets $0.044 — Availability likely —
Fleet 5 mg 00132-0401-25 C.B. 25 tablets — — FDA listed —
Gentle Laxative 5 mg 00363-0327-03 Walgreen 10 tablets — — FDA listed —
Laxative 5 mg 00363-6760-01 Walgreen 15 tablets — — FDA listed —
up and up gentle laxative 5 mg 11673-0116-25 Target 25 tablets — — FDA listed —
Womens Gentle Laxative 5 mg 11673-0151-52 TARGET 25 tablets — — FDA listed —
Bisacodyl 5 mg 11673-0182-52 TARGET 25 tablets — — FDA listed —
laxative for women 5 mg 11822-0676-05 Rite 15 tablets — — FDA listed —
Laxative 5 mg 11822-0790-01 Rite 25 tablets — — FDA listed —
Gentle Laxative 5 mg 21130-0410-20 BETTER 200 tablets — — FDA listed —
Womens Gentle Laxative 5 mg 21130-0555-30 BETTER 30 tablets — — FDA listed —
Gentle Overnight Laxative 5 mg 21130-0827-06 Better 200 tablets — — Discontinued —
Laxative Gentle 5 mg 30142-0827-12 Kroger 25 tablets — — FDA listed —
Gentle Laxative 5 mg 36800-0327-03 Topco 10 tablets — — FDA listed —
Gentle Laxative 5 mg 37808-0327-15 H 25 tablets — — FDA listed —
Womens Laxative 5 mg 37808-0676-11 H 15 tablets — — Discontinued —
Gentle Laxative 5 mg 37808-0680-11 H 15 tablets — — FDA listed —
Laxative 5 mg 37835-0241-01 Bi-Mart 100 tablets — — FDA listed —
Gentle Laxative 5 mg 37835-0244-30 Bi-Mart 15 tablets — — FDA listed —
Gentle Laxative 5 mg 41163-0607-52 United 18 tablets — — FDA listed —
Dulcolax Simulant Laxative 5 mg 41167-0101-00 Chattem, 8 tablets — — FDA listed —
Dulcolax Stimulant Laxative 5 mg 41167-0200-01 Chattem, 10 tablets — — FDA listed —
Dulcolax Pink Stimulant Laxative 5 mg 41167-0290-05 Chattem, 25 tablets — — FDA listed —
Dulcolax Stimulant Laxative 5 mg 41167-0400-01 Chattem, 10 tablets — — FDA listed —
Bisacodyl 5 mg 41226-0003-52 KROGER 25 tablets — — FDA listed —
Womens Laxative 5 mg 41226-0151-52 KROGER 25 tablets — — FDA listed —
gentle laxative 5 mg 41250-0339-56 Meijer 25 tablets — — FDA listed —
Womens gentle laxative 5 mg 41250-0676-11 Meijer 15 tablets — — FDA listed —
Publix Stimulant Laxative 5 mg 41415-0116-25 PUBLIX 25 tablets — — FDA listed —
Publix Women Laxative 5 mg 41415-0121-30 PUBLIX 30 tablets — — FDA listed —
Gentle Laxative 5 mg 49035-0327-12 Wal-Mart 100 tablets — — FDA listed —
Gentle Laxative 5 mg 49035-0706-12 Wal-Mart 100 tablets — — FDA listed —
Stimulant Laxative 5 mg 49483-0003-00 TIME 100000 tablets — — FDA listed —
Bisacodyl Laxative 5 mg 50804-0327-56 Geiss, 25 tablets — — FDA listed —
Gentle Laxative 5 mg 50844-0327-15 L.N.K. 25 tablets — — FDA listed —
Womens Gentle Laxative 5 mg 53943-0676-01 Discount 15 tablets — — FDA listed —
Gentle Laxative 5 mg 53943-0677-01 Discount 15 tablets — — FDA listed —
Bisacodyl 5 mg 55154-6897-00 Cardinal 1 tablet — — FDA listed —
Laxative 5 mg 55319-0327-15 Family 25 tablets — — FDA listed —
Gentle Laxative 5 mg 55319-0697-56 Family 25 tablets — — FDA listed —
Laxomil 5 mgthis 55758-0504-01 Pharmadel 24 tablets — — FDA listed —
Gentle Laxative 5 mg 55910-0327-62 DOLGENCORP, 15 tablets — — FDA listed —
Laxative Gentle 5 mg 55910-0723-62 DOLGENCORP, 15 tablets — — FDA listed —
Laxative 5 mg 55910-0792-56 DOLGENCORP, 25 tablets — — FDA listed —
Extra Gentle Laxative 5 mg 55910-0954-52 DOLGENCORP 25 tablets — — FDA listed —
laxative 5 mg 56062-0327-56 Publix 25 tablets — — FDA listed —
Laxative 5 mg 56062-0976-01 Publix 15 tablets — — FDA listed —
stimulant laxative enteric coated 5 mg 57896-0441-01 Geri-Care 100 tablets — — FDA listed —
Gentle Laxative 5 mg 59779-0327-03 CVS 10 tablets — — FDA listed —
C-Lax Laxative 5 mg 59779-0676-13 CVS 250 tablets — — FDA listed —
Womens Gentle Laxative 5 mg 63868-0573-30 CHAIN 15 tablets — — FDA listed —
Gentle Laxative Stimulant Laxative 5 mg 63868-0908-25 QUALITY 25 tablets — — FDA listed —
Stimulant Laxative Enteric Coated 5 mg 66424-0002-01 SDA 100 tablets — — FDA listed —
Laxative Gentle 5 mg 67091-0215-25 WinCo 25 tablets — — FDA listed —
Laxative Women 5 mg 67091-0286-30 WinCo 15 tablets — — Discontinued —
Laxative 5 mg 67091-0452-24 WinCo 15 tablets — — FDA listed —
Bisacodyl 5 mg 68016-0688-10 Chain 100 tablets — — FDA listed —
Bisacodyl Stimulant Laxative 5 mg 68163-0116-25 Raritan 25 tablets — — FDA listed —
Womens Laxative 5 mg 68998-0398-85 Marc 25 tablets — — FDA listed —
Laxative Enteric Coated 5 mg 68998-0404-92 Marc 25 tablets — — FDA listed —
Bisacodyl 5mg 5 mg 69168-0398-92 Allegiant 25 tablets — — FDA listed —
Laxative Enteric Coated 5 mg 69168-0404-03 Allegiant 250 tablets — — FDA listed —
stimulant laxative 5 mg 69452-0541-83 BIONPHARMA 300 tablets — — FDA listed —
Womens Gentle Laxative 5 mg 69842-0089-52 CVS 25 tablets — — FDA listed —
Womens Laxative Enteric Coated 5 mg 70000-0570-01 CARDINAL 25 tablets — — FDA listed —
GOOD REMEDIES GENTLE Laxative 5 mg 70692-0167-52 Strive 25 tablets — — FDA listed —
RIGHT REMEDIES OVERNIGHT Laxative 5 mg 70692-0761-31 Strive 300 tablets — — FDA listed —
stimulant laxative enteric coated 5 mg 71335-1531-00 Bryant 25 tablets — — FDA listed —
Bisacodyl 5 mg 71335-2010-00 Bryant 25 tablets — — FDA listed —
stimulant laxative enteric coated 5 mg 71610-0453-02 Aphena 2 tablets — — FDA listed —
Bisacodyl 5 mg 71610-0700-02 Aphena 2 tablets — — FDA listed —
Bisacodyl 5 mg 72090-0131-01 Pioneer 300 tablets — — FDA listed —
Laxative 5 mg 76162-0676-01 TOPCO 15 tablets — — FDA listed —
SIMPEX Bisacodyl laxative 5 mg 76457-0003-00 Simpex 100 tablets — — FDA listed —
Gentle Laxative 5 mg 79903-0178-08 Wal-Mart 8 tablets — — FDA listed —
Laxative 5 mg 80513-0409-20 Advanced 200 tablets — — FDA listed —
Laxative 5 mg 83586-0116-01 HHH 100 tablets — — FDA listed —
Bisacodyl 5 mg 84324-0132-01 NUVICARE 100 tablets — — FDA listed —
stimulant laxative enteric coated 5 mg 85766-0148-00 Sportpharm 1000 tablets — — FDA listed —
Laxative Enteric Coated 5 mg 85828-0404-92 Grocery 25 tablets — — 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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

Color orange
ShapeRound
ImprintB5
Size6 mm
ScoringNot scored
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.

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

  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII 1CS02G8656
    Methacrylic acid is a synthetic polymer used as a coating material and binder in tablets and capsules. It helps control how and where the medication releases in the digestive system.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • 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.

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

The official label also statesD&C yellow #10, FD&C yellow #6, hypromellose, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium starch glycolate type A, talc, titanium dioxide,triethyl citrate, water

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

LabelerPharmadel LLC
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code55758
First marketedJul 2025
Product typeHuman Otc Drug
Portfolio67 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Use For relief of occasional constipation (irregularity). This product generally produces bowel movement in 6 to 12 hours.

⏱️ Dosage and Administration 52 words ▾

Directions take with plenty of water do not chew or crush tablet(s) Age Dose adults and children 12 years and older take 1 to 3 tablets in a single dose, once a day children 6 to undee 12 years take 1 tablet once a day children under 6 years consult a doctor

⚠️ Warnings 145 words ▾

Warnings Do not use if you cannot swallow without chewing. These tablets should not be chewed because gastric irritation may occur. Ask a doctor before use if you have abdominal pain, nausea, or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks When using this product take this product 2 hours before or after other drugs do not take this product within 1 hour after taking an antacid or milk Stop use and ask a doctor if you need to use for more than 7 days rectal bleeding occurs you fail to have a bowel movement after use of a laxative.

This may indicate 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 right away.

🧪 Active Ingredient 16 words ▾

Active ingredients and Purposes Active ingredientes (in each tablet) Purpose Bisacodyl 5 mg ......... Stimulant laxative

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients D&C yellow #10, FD&C yellow #6, hypromellose, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium starch glycolate type A, talc, titanium dioxide,triethyl citrate, water

🎯 Purpose 12 words ▾

Active ingredientes (in each tablet) Purpose Bisacodyl 5 mg ......... Stimulant laxative

📄 Do Not Use 20 words ▾

Do not use if you cannot swallow without chewing. These tablets should not be chewed because gastric irritation may occur.

📄 Ask a Doctor Before Use If 28 words ▾

Ask a doctor before use if you have abdominal pain, nausea, or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks

📄 When Using This Product 28 words ▾

When using this product take this product 2 hours before or after other drugs do not take this product within 1 hour after taking an antacid or milk

📄 Stop Use and Ask a Doctor If 37 words ▾

Stop use and ask a doctor if you need to use for more than 7 days rectal bleeding occurs you fail to have a bowel movement after use of a laxative. This may indicate 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 21 words ▾

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

📄 Other Information 18 words ▾

Other information store between 68-77°F (20-25°C) do not use if seal under cap is torn, broken or missing

📄 Questions or Comments 11 words ▾

Questions? +1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com

📄 Package Label / Principal Display Panel 2 words ▾

PDP LAXOMIL

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 Laxomil (this brand).

Top reported reactions

Disorientation2
Hypernatraemia2
Hypokalaemia2
Hyponatraemia2
Subileus2
Vomiting2
Abdominal Pain Upper1

Age at onset

Elderly2

Reporter sex

9 reports
Male · 56%
Female · 44%

Serious outcomes

Hospitalization4
Life-threatening1
Death1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3 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

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 Pharmadel LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharmadel 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.
← 55758-0503-24 · Pharmadel 55758-0505-01 · Pharmadel →
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.