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Dulcolax Stimulant Laxative Bisacodyl 5 mg Tablet, Coated — NDC 41167-0400-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dulcolax Stimulant Laxative Bisacodyl 5 mg Tablet, Coated — NDC 41167-0400-3 (Billing 41167-0400-03)

by Chattem, Inc. · 2 BLISTER PACK in 1 CARTON / 25 TABLET, COATED in 1 BLISTER PACK

This is a package of Dulcolax Stimulant Laxative Bisacodyl 5 mg Tablet, Coated from Chattem, Inc., marketed since Apr 2019 and currently FDA-listed.

NDC 41167-0400-03
🏷️ FDA NDC (as labeled) 41167-0400-3 billing pads the package segment with a zero
This package
Contains25 tablet, coated in 1 blister pack Pack sizes8 compare ↓
Product page 41167-0400-01 Also comes in: 6 tablets 41167-0400-9 8 tablets 41167-0400-5 10 tablets 41167-0400-1 10 tablets 41167-0400-8 25 tablets 41167-0400-2 25 tablets 41167-0400-4 25 tablets 41167-0400-6
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 41167-0400-3 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
41167 labeler · 0400 product · 3 package
Package marketed since
Apr 14, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4116704003 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 41167-0400-3
Product NDC 41167-0400
11-digit billing NDC 41167040003
RxCUI 209613, 308753
UNII 10X0709Y6I
Application # 505G(a)(3)
SPL Set ID f1e4b28a-ed74-4eff-bd10-b2bfaf7483b0
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 2019-04-14
Route ORAL
Dosage form TABLET, COATED
Substance BISACODYL

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

GPI-14 47300010001805
GPI class Kaopectate
GCN Seq No 002858
GCN 26970
HICL code 001246
Ingredient (HICL) Bismuth Subsalicylate
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 D6D
Therapeutic class — specific (HIC3) Antidiarrheals
AHFS code 56:04.00.00
AHFS class Antacids And Adsorbents
FDB label name KAOPECTATE 262 MG/15 ML SUSP
FDB brand name Kaopectate
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 002858
  • GCN: 26970
  • GPI-14 (Medi-Span): 47300010001805
  • HICL (First Databank): 001246
  • AHFS class code: 56:04.00.00
  • RxCUI (RxNorm): 209613
Why two NDCs? The FDA registers this code as 41167-0400-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 41167-0400-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the 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

Label name KAOPECTATE 262 MG/15 ML SUSP Ingredient Bismuth Subsalicylate
📖 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.
Try another pack size: 6 tablets 8 tablets 10 tablets 10 tablets 25 tablets 25 tablets 25 tablets
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
41167-0400-01 41167-0400-1 Main listing 1 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK 2019-04-14 — Active
41167-0400-02 41167-0400-2 1 BLISTER PACK in 1 CARTON / 25 TABLET, COATED in 1 BLISTER PACK 2019-04-14 — Active
41167-0400-03 You're viewing this 2 BLISTER PACK in 1 CARTON / 25 TABLET, COATED in 1 BLISTER PACK 2019-04-14 — Active
41167-0400-04 41167-0400-4 4 BLISTER PACK in 1 CARTON / 25 TABLET, COATED in 1 BLISTER PACK 2019-06-03 — Active
41167-0400-05 41167-0400-5 1 BLISTER PACK in 1 CARTON / 8 TABLET, COATED in 1 BLISTER PACK 2019-04-14 — Active
41167-0400-06 41167-0400-6 8 BLISTER PACK in 1 CARTON / 25 TABLET, COATED in 1 BLISTER PACK 2019-04-14 — Active
41167-0400-08 41167-0400-8 3 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK 2019-05-01 — Active
41167-0400-09 41167-0400-9 1 BLISTER PACK in 1 CARTON / 6 TABLET, COATED in 1 BLISTER PACK 2022-06-01 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 blister pack in 1 carton / 25 tablet, coated in 1 blister pack.
What NDC number is used to bill for this package of Dulcolax Stimulant Laxative Bisacodyl 5 mg Tablet, Coated?
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
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 mgthis 41167-0400-03 Chattem, 25 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 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 —
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

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 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 orange
ShapeRound
ImprintDL
Size5 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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

LabelerChattem, Inc.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code41167
First marketedApr 2019
Product typeHuman Otc Drug
Portfolio157 products on file

More NDCs from Chattem, Inc. labeler code 41167

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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 42 words ▾

Use ● for relief of occasional constipation and irregularity ● this product generally produces bowel movement in 6 to 12 hours

Use ● for relief of occasional constipation and irregularity ● this product generally produces bowel movement in 6 to 12 hours

⏱️ Dosage and Administration 98 words ▾

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

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

⚠️ Warnings ~1 min read ▾

Warnings Do not use ● if you cannot swallow without chewing Ask a doctor before use if you have ● stomach pain, nausea or vomiting ● noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product ● it may cause stomach discomfort, faintness and cramps ● do not chew or crush tablet(s) ● do not use within 1 hour after taking an antacid or milk Stop use and ask a doctor if ● you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. ● you need to use a laxative for more than 1 week If pregnant or b reast-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.

Warnings Do not use ● if you cannot swallow without chewing Ask a doctor before use if you have ● stomach pain, nausea or vomiting ● noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product ● it may cause stomach discomfort, faintness and cramps ● do not chew or crush tablet(s) ● do not use within 1 hour after taking an antacid or milk Stop use and ask a doctor if ● you have rectal bleeding or fail to have a bowel movement after using this product. 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 of overdose, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 18 words ▾

Active ingredient (in each tablet) Bisacodyl (USP) 5 mg

Active ingredient (in each tablet) Bisacodyl (USP) 5 mg

🧪 Inactive Ingredients 120 words ▾

Inactive ingredients acacia senegal gum, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxides, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Inactive ingredients acacia senegal gum, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxides, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

🎯 Purpose 6 words ▾

Purpose Stimulant laxative

Purpose Stimulant laxative

📄 Do Not Use 20 words ▾

Do not use ● if you cannot swallow without chewing

Do not use ● if you cannot swallow without chewing

📄 Ask a Doctor Before Use If 56 words ▾

Ask a doctor before use if you have ● stomach pain, nausea or vomiting ● noticed a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor before use if you have ● stomach pain, nausea or vomiting ● noticed a sudden change in bowel habits that lasts more than 2 weeks

📄 When Using This Product 66 words ▾

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

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

📄 Stop Use and Ask a Doctor If 86 words ▾

Stop use and ask a doctor if ● you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. ● you need to use a laxative for more than 1 week

Stop use and ask a doctor if ● you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition. ● you need to use a laxative for more than 1 week

🤰 If Pregnant or Breast-Feeding 21 words ▾

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

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

📄 Keep Out of Reach of Children 42 words ▾

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

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

📄 Questions or Comments 44 words ▾

Questions? Call 1- 866 - 844 - 2798 or visit www.Dulcolax.com Keep carton as it contains important product information. Dulcolax Stimulant Laxative Tablets Drug Facts

Questions? Call 1- 866 - 844 - 2798 or visit www.Dulcolax.com Keep carton as it contains important product information.

📄 Package Label / Principal Display Panel 30 words ▾

PRINCIPAL DISPLAY PANEL Dulcolax LAXATIVE 200 TABLETS PRINCIPAL DISPLAY PANEL Dulcolax LAXATIVE 200 TABLETS

PRIN CI PAL DISPLAY PANEL Dulcolax LAXATIVE 50 TABLETS PRINICPAL DISPLAY PANEL Dulcolax LAXATIVE 50 TABLETS

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 Dulcolax Stimulant Laxative (this brand).

Top reported reactions

Constipation1,460
Nausea1,352
Pain1,094
Vomiting985
Fall827
Dyspnoea823
Pneumonia798

Reporter sex

12,925 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization6,865
Death2,302
Life-threatening1,059
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,143 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Chattem, 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 7 other package presentations of this same product, including 6 tablets (41167-0400-09), 8 tablets (41167-0400-05), 10 tablets (41167-0400-01). 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?
Chattem, 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.
← 41167-0364-01 · Chattem, 41167-0410-04 · Chattem, →
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.