Anti-Diarrheal/Anti-Gas Loperamide Hydrochloride, Simethicone 2 mg; 125 mg Tablet, 24-count — NDC 53943-0263-33 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Anti-Diarrheal/Anti-Gas Loperamide Hydrochloride, Simethicone 2 mg; 125 mg Tablet, 24-count — NDC 53943-263-33 (Billing 53943-0263-33)

by Discount Drug Mart, Inc · 4 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK

This is a package of 24 tablets of Anti-Diarrheal/Anti-Gas Loperamide Hydrochloride, Simethicone 2 mg; 125 mg Tablet from Discount Drug Mart, Inc, marketed since Feb 2025 and currently FDA-listed. It is this product's only package size.

NDC 53943-0263-33
🏷️ FDA NDC (as labeled) 53943-263-33 billing pads the product segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 53943-263-33
Product NDC 53943-263
11-digit billing NDC 53943026333
RxCUI 978001
UNII 77TI35393C, 92RU3N3Y1O
UPC 0093351033209
Application # ANDA214541
SPL Set ID 2e0b3aec-f436-c0fb-e063-6394a90abb51
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-02-26
Route ORAL
Dosage form TABLET
Substance LOPERAMIDE HYDROCHLORIDE; DIMETHICONE
Quick answers
  • RxCUI (RxNorm): 978001
Why two NDCs? The FDA registers this code as 53943-263-33 — 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 → 53943-0263-33. 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 Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Antipropulsives
How it works Opioid Agonists
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

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
53943-0263-33 You're viewing this Main listing 4 BLISTER PACK in 1 CARTON / 6 TABLET in 1 BLISTER PACK 2025-02-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense anti diarrheal anti gas 2 mg/1; 125 mg 00113-0087-53 L. 12 tablets $0.286 — Availability likely —
good neighbor pharmacy anti diarrheal anti gas 2 mg/1; 125 mg 46122-0620-62 Amerisource 24 tablets $0.286 — Availability likely —
foster and thrive anti diarrheal anti gas 2 mg/1; 125 mg 70677-1105-01 Strategic 12 tablets $0.286 — Availability likely —
Good Sense Anti Diarrheal Anti Gas 2 mg/1; 125 mg 00113-1087-89 L. 18 tablets — — FDA listed —
anti diarrheal and anti gas 2 mg/1; 125 mg 00363-1830-53 Walgreen 12 tablets — — FDA listed —
Loperamide Hydrochloride and Simethicone 2 mg/1; 125 mg 00363-9606-75 WALGREEN 12 tablets — — FDA listed —
up and up anti diarrheal anti gas 2 mg/1; 125 mg 11673-0646-62 Target 24 tablets — — FDA listed —
signature care anti diarrheal anti gas 2 mg/1; 125 mg 21130-0183-62 Safeway 24 tablets — — FDA listed —
Loperamide Hydrochloride and Simethicone 2 mg/1; 125 mg 21130-0222-24 Better 24 tablets — — FDA listed —
Anti Diarrheal Anti Gas 2 mg/1; 125 mg 30142-0581-53 Kroger 12 tablets — — FDA listed —
anti diarrheal anti gas 2 mg/1; 125 mg 37808-0714-53 H 12 tablets — — FDA listed —
equaline anti diarrheal plus anti gas 2 mg/1; 125 mg 41163-0553-89 United 18 tablets — — FDA listed —
anti diarrheal plus anti gas 2 mg/1; 125 mg 41250-0375-55 Meijer 42 tablets — — Discontinued —
CareOne Diarrhea and Gas Control 2 mg/1; 125 mg 41520-0772-53 American 12 tablets — — FDA listed —
anti diarrheal anti gas 2 mg/1; 125 mg 42507-0699-53 HyVee 12 tablets — — FDA listed —
IMODIUM Multi-Symptom Relief 2 mg/1; 125 mg 50580-0338-12 Kenvue 12 tablets — — FDA listed —
Loperamide HCl and Simethicone 2 mg/1; 125 mg 51660-0069-06 Ohm 6 tablets — — FDA listed —
Loperamide Hydrochloride, Simethicone 2 mg/1; 125 mg 53041-0263-50 Guardian 6 tablets — — FDA listed —
Anti-Diarrheal/Anti-Gas 2 mg/1; 125 mgthis 53943-0263-33 Discount 24 tablets — — FDA listed —
Loperamide Hydrochloride and Simethicone 2 mg/1; 125 mg 55319-0052-75 Family 12 tablets — — FDA listed —
dg health anti diarrheal anti gas 2 mg/1; 125 mg 55910-0383-53 Dolgencorp, 12 tablets — — FDA listed —
antidiarrheal multi symptom relief 125 mg/1; 2 mg 56062-0511-62 Publix 24 tablets — — Discontinued —
Loperamide Hydrochloride and Simethicone 2 mg/1; 125 mg 58602-0815-74 Aurohealth 6 tablets — — FDA listed —
Loperamide Hydrochloride and Simethicone 2 mg/1; 125 mg 58602-0868-76 Aurohealth 24 tablets — — FDA listed —
Loperamide Hydrochloride and Simethicone 2 mg/1; 125 mg 58602-0869-76 Aurohealth 24 tablets — — FDA listed —
Loperamide Hydrochloride and Simethicone 2 mg/1; 125 mg 62207-0739-69 Granules 12 tablets — — FDA listed —
Loperamide Hydrochloride and Simethicone 2 mg/1; 125 mg 69230-0325-04 Camber 4 tablets — — FDA listed —
Anti-Diarrheal/Anti-Gas 2 mg/1; 125 mg 69256-0265-31 Harris 12 tablets — — FDA listed —
Loperamide hydrochloride and Simethicone 2 mg/1; 125 mg 69452-0210-04 Bionpharma 6 tablets — — FDA listed —
Loperamide hydrochloride and Simethicone 2 mg/1; 125 mg 69452-0531-12 Bionpharma 24 tablets — — FDA listed —
anti diarrheal and anti gas 2 mg/1; 125 mg 69842-0644-53 CVS 12 tablets — — FDA listed —
Basic Care Loperamide Hydrochloride and Simethicone 2 mg/1; 125 mg 72288-0001-62 Amazon.com 24 tablets — — FDA listed —
Anti-Diarrheal/Anti-Gas Caplets 2 mg/1; 125 mg 73581-0178-24 YYBA 24 tablets — — FDA listed —
Anti-Diarrheal/Anti-Gas Multi-Symptom Relief 2 mg/1; 125 mg 79903-0116-33 Wal-Mart 24 tablets — — FDA listed —
Loperamide Hydrochloride and Simethicone 2 mg/1; 125 mg 79903-0223-12 WALMART 12 tablets — — FDA listed —
Equate Anti Diarrheal Anti Gas Multi-Symptom Relief 2 mg/1; 125 mg 79903-0302-12 WALMART 12 tablets — — FDA listed —
Loperamide Hydrochloride and Simethicone 2 mg/1; 125 mg 80136-0384-24 NORTHEAST 24 tablets — — FDA listed —
Loperamide Hydrochloride and Simethicone 2 mg/1; 125 mg 81522-0325-24 FSA 24 tablets — — FDA listed —
Loperamide Hydrochloride and Simethicone 125 mg/1; 2 mg 84441-0713-10 IMO-GEN 100 tablets — — FDA listed —
anti diarrheal anti gas 2 mg/1; 125 mg 11822-1003-01 Rite 42 tablets — — Discontinued —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

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

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

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • 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 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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

The official label also statesacesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

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

LabelerDiscount Drug Mart, Inc
Application holderGUARDIAN DRUG CO
FDA applicationANDA214541 (ANDA)
Labeler code53943
First marketedFeb 2025
Product typeHuman Otc Drug
Portfolio42 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 15 words ▾

USE(S) relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

⏱️ Dosage and Administration 159 words ▾

DIRECTIONS drink plenty of clear fluids to help prevent dehydration caused by diarrhea take only on an empty stomach (1 hour before or 2 hours after a meal) take with a full (8 oz.) glass of water find right dose on chart below. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use

⚠️ Warnings 33 words ▾

WARNINGS Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Heart alert: Taking more than directed can cause serious heart problems or death

📦 Storage and Handling 28 words ▾

OTHER INFORMATION each caplet contains: calcium 180 mg, sodium 3 mg store between 20-25°C (68-77°F). Protect from light. do not use if blister unit is torn or broken

🧪 Active Ingredient 12 words ▾

ACTIVE INGREDIENTS (in each caplet) Loperamide HCl 2 mg Simethicone 125 mg

🧪 Inactive Ingredients 17 words ▾

INACTIVE INGREDIENTS acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

🎯 Purpose 3 words ▾

PURPOSE Anti-diarrheal Anti-gas

📄 Do Not Use 15 words ▾

DO NOT USE if you have bloody or black stool if you have difficulty swallowing

📄 Ask a Doctor Before Use If 25 words ▾

ASK A DOCTOR BEFORE USE IF THE CHILD HAS fever mucus in the stool a history of liver disease a history of abnormal heart rhythm

📄 Ask a Doctor or Pharmacist Before Use If 21 words ▾

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking a prescription drug. Loperamide may interact with certain prescription drugs.

📄 When Using This Product 17 words ▾

WHEN USING THIS PRODUCT tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

📄 Stop Use and Ask a Doctor If 36 words ▾

STOP USE AND ASK DOCTOR IF symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition. you have difficulty swallowing the caplet

🤰 If Pregnant or Breast-Feeding 11 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 right away. (1-800-222-1222)

📄 Package Label / Principal Display Panel 85 words ▾

PRINCIPAL DISPLAY PANEL *Compare to the Active Ingredients in IMODIUM ® Multi-symptom Relief Caplet. DISCOUNT drug mart FOOD FAIR Anti-diarrheal/Anti-gas Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg Multi-symptom Relief Caplet Relieves Symptoms of Diarrhea Plus Cramps & Pressure Bloating Gas 24 Caplets** **Capsule-Shaped Tablets Harris Teeter™ NDC 69256-265-73 MULTI-SYMPTOM RELIEF ANTI-DIARRHEAL/ANTI-GAS Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg Relieves Symptoms of Diarrhea Plus Cramps & Pressure Bloating, Gas Compare to the active ingredients in Imodium® Multi-Symptom Relief Caplet* 24 Caplets** **Capsule-Shaped Tablets 263-24-ddm.jpg

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

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

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 Discount Drug Mart, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Discount Drug Mart, 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.