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SIMPEX Bisacodyl laxative 5 mg Tablet, Coated, 100-count — NDC 76457-0003-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SIMPEX Bisacodyl laxative 5 mg Tablet, Coated, 100-count — NDC 76457-003-00 (Billing 76457-0003-00)

by Simpex Pharma Pvt. Ltd · 100 TABLET, COATED in 1 CARTON

This is a package of 100 tablets of SIMPEX Bisacodyl laxative 5 mg Tablet, Coated from Simpex Pharma Pvt. Ltd, marketed since Feb 2018 and currently FDA-listed. It is this product's only package size.

NDC 76457-0003-00
🏷️ FDA NDC (as labeled) 76457-003-00 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

NDC database record

One package, one record: these facts belong to NDC 76457-003-00 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
76457 labeler · 003 product · 00 package
Package marketed since
Feb 9, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
8901252955389
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76457-003-00
Product NDC 76457-003
11-digit billing NDC 76457000300
RxCUI 308753
UNII 10X0709Y6I
UPC 8901252955389
Application # M007
SPL Set ID 5114ed64-4fec-401b-8a91-8df3e42b10b1
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 2018-02-09
Route ORAL
Dosage form TABLET, COATED
Substance BISACODYL
Quick answers
  • RxCUI (RxNorm): 308753
Why two NDCs? The FDA registers this code as 76457-003-00 — 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 → 76457-0003-00. 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 →
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
76457-0003-00 You're viewing this Main listing 100 TABLET, COATED in 1 CARTON 2018-02-09 — 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 mg 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 mgthis 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 —
HyVee Stimulant Laxative 5 mg 42507-0167-10 HyVee 10 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

🏛️
2018
On the market since
Feb 2018
📍
2026
Currently FDA-listed
8 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

Color white
ShapeCapsule
Imprint;
Size16 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.

🧪 Avoiding an ingredient? See Bisacodyl 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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII Z78RG6M2N2
    Hypromellose 2208 is a plant-derived thickening agent used as a binder and film-coating material in tablets and capsules. It helps hold ingredients together and creates a protective coating that controls how quickly the medicine dissolves.
  • 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 NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII NL4J9F21N9
    Polyethylene glycol 600 is a synthetic liquid polymer used as a solvent and humectant in medicines. It helps dissolve active ingredients and keeps products from drying out.
  • 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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.

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

The official label also statesanhydrous lactose, colloidal anhydrous silica, hypermellose, iron oxide red, iron oxide yellow, macrogol, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, povidone, sodium bicarbonate, sodiumlauryl sulfate, sodium starch glycolate type A, talc, titanium dioxide,triethyle citrate

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

LabelerSimpex Pharma Pvt. Ltd
FDA applicationM007 (OTC MONOGRAPH DRUG)
Labeler code76457
First marketedFeb 2018
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from Simpex Pharma Pvt. Ltd labeler code 76457

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

Uses relives occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours

⏱️ Dosage and Administration 47 words ▾

Directions take with a glass of water. Adults and children 12 years and over take 1 to 3 tablets in a single daily dose Children 6 to under 12 years of age take 1 tablet in a single daily dose Children under 6 years ask a doctor

⚠️ Warnings 137 words ▾

Warnings Do not use if you can not swallow without chewing. ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than weeks When using this product do not chew or crush tablet (s) do not use within 1 hour after taking an antacid or milk you may have stomach discomfort, faintness or cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use a laxative. these could be signs of a serious condition. you need to use a laxative for more than 1 week if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children.

In case or overdose, get medical help orcontact a poison control center right away.

🧪 Active Ingredient 11 words ▾

Active ingredient (in each tablet) Bisacodyl 5 mg Purpose Stimulant Laxative

🧪 Inactive Ingredients 44 words ▾

Inactive ingredients anhydrous lactose, colloidal anhydrous silica, hypermellose, iron oxide red, iron oxide yellow, macrogol, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, povidone, sodium bicarbonate, sodiumlauryl sulfate, sodium starch glycolate type A, talc, titanium dioxide,triethyle citrate

🎯 Purpose 3 words ▾

Purpose Stimulant Laxative

📄 Do Not Use 34 words ▾

Do not use if you can not swallow without chewing. ask a doctor before use if you have stomach pain, nausea or vomiting a sudden change in bowel habits that lasts more than weeks

📄 When Using This Product 31 words ▾

When using this product do not chew or crush tablet (s) do not use within 1 hour after taking an antacid or milk you may have stomach discomfort, faintness or cramps

📄 Stop Use and Ask a Doctor If 51 words ▾

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use a laxative. these could be signs of a serious condition. you need to use a laxative for more than 1 week if pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

keep out of reach of children. In case or overdose, get medical help orcontact a poison control center right away.

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label3

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 SIMPEX Bisacodyl laxative (this brand).

Top reported reactions

Constipation1,456
Nausea1,344
Pain1,088
Vomiting976
Fall825
Dyspnoea822
Pneumonia798

Age at onset

Neonate2
Child47
Adolescent30
Adult931
Elderly1,240

Reporter sex

12,862 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Death2,299
Life-threatening1,053
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1,337 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 Simpex Pharma Pvt. Ltd. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Simpex Pharma Pvt. Ltd 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.
← 76457-0002-00 · Simpex 76457-0004-00 · Simpex →
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.