Home › NDC Lookup › Ingredients › Loperamide Hydrochloride › 41226-0797-22
Anti-Diarrheal Loperamide Hydrochloride 2 mg Tablet, Film Coated — NDC 41226-0797-22 package photo

Anti-Diarrheal Loperamide Hydrochloride 2 mg Tablet, Film Coated

by Kroger · 2 BLISTER PACK in 1 CARTON (41226-797-22) / 6 TABLET, FILM COATED in 1 BLISTER PACK
NDC 41226-0797-22
🏷️ FDA NDC (as labeled) 41226-797-22 billing pads the product segment with a zero
This package
Contains6 tablet, film coated in 1 blister pack Pack sizes2 compare ↓
Also comes in: 6 tablets 41226-0797-24
OTC Generic On market Non-controlled
🗂️ Data synced Sep 25, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 41226-797-22
Product NDC 41226-797
11-digit billing NDC 41226079722
Application # ANDA220153
SPL Set ID 5159e18e-042f-0625-e063-6394a90a5bdb
Established class (EPC) Opioid Agonist
Mechanism of action Opioid Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-18
Route ORAL
Dosage form TABLET, FILM COATED
Substance LOPERAMIDE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 41226-797-22 — 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 → 41226-0797-22. 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.

🏭 Manufacturer & labeler

LabelerKroger
Application holderMARKSANS PHARMA LTD
FDA applicationANDA220153 (ANDA)
Labeler code41226
First marketedSep 2026
Product typeHuman Otc Drug
Portfolio39 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Loperamide works by binding to the same type of receptors in your gut that opioids do, but it stays mostly in the intestines and very little gets into your bloodstream at the recom...
  • What exactly does loperamide do — and is it like taking an opioid?
  • For acute diarrhea, stop and call your doctor if symptoms don't improve within 2 days, or if they get worse. You should also stop right away if you develop bloating or a swollen be...
  • How long can I take loperamide before I should see a doctor?
📖 Read our full Loperamide 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.

💊 What it looks like

Color white
ShapeCapsule
ImprintL;2
Size1 mm
ScoringScored — splits in 2
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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • 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 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 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 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.

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

The official label also statescarnauba wax, colloidal silicon dioxide, croscarmellose sodium, hydroxy propyl methyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

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.

💲 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
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
anti diarrheal 2 mg 00904-7725-12 Major 1 tablet $0.130 — Availability likely —
Loperamide Hydrochloride 2 mg 46122-0738-53 Amerisource 12 tablets $0.130 — Availability likely —
Good Sense anti diarrheal 2 mg 00113-0224-53 L. 1 tablet $0.130 — Availability likely —
Loperamide Hydrochloride 2 mg 58602-0870-76 Aurohealth 24 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 63187-0462-12 Proficient 12 tablets — — FDA listed —
Good Sense anti diarrheal 2 mg 71205-0079-12 Proficient 1 tablet — — FDA listed —
WELMATE Anti Diarrheal Loperamide HCl 2 mg 73581-0101-24 YYBA 24 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 35418-0123-12 Zee 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 51660-0123-06 Ohm 6 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 53943-0123-12 Discount 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 55315-0123-06 Fred's 6 tablets — — FDA listed —
anti diarrheal 2 mg 59779-0700-53 CVS 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 63868-0338-12 Chain 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 63941-0123-12 Valu 12 tablets — — FDA listed —
Handy Solutions Anti-Diarrheal 2 mg 67751-0162-01 Navajo 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 68016-0123-06 Chain 6 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 68998-0123-24 Marc 24 tablets — — FDA listed —
Up and Up anti diarrheal 2 mg 11673-0224-02 Target 24 tablets — — Discontinued —
anti diarrheal 2 mg 41250-0224-53 Meijer 1 tablet — — FDA listed —
MEDIQUE Diamode 2 mg 71205-0316-01 Proficient 1 tablet — — FDA listed —
Good Sense anti diarrheal 2 mg 51655-0663-54 Northwind 15 tablets — — FDA listed —
anti diarrheal 2 mg 67296-1472-07 Redpharm 24 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 68788-8393-02 Preferred 24 tablets — — FDA listed —
anti diarrheal 2 mg 42507-0224-53 HyVee 1 tablet — — FDA listed —
MEDIQUE Diamode 2 mg 47682-0200-33 Unifirst 100 tablets — — Discontinued —
Imodium A-D 2 mg 50580-0317-01 Kenvue 6 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 58602-0701-01 Aurohealth 6 tablets — — FDA listed —
Amazon Basic Care Loperamide Hydrochloride 2 mg 72288-0225-76 Amazon.com 24 tablets — — FDA listed —
MEDIQUE Diamode 2 mg 47682-0400-46 Unifirst 1 tablet — — FDA listed —
Anti-Diarrheal 2 mg 66424-0725-24 SDA 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 80513-0401-24 Advanced 24 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 84386-0117-24 Aurobindo 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 84441-0711-02 IMO-GEN 200 tablets — — FDA listed —
Amazon Basic Care Loperamide Hydrochloride 2 mg 82804-0295-06 Proficient 6 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 53329-0664-57 Medline 12 tablets — — FDA listed —
Good Sense anti diarrheal 2 mg 68788-8750-02 Preferred 1 tablet — — FDA listed —
Lil Drug Store Anti-Diarrheal 2 mg 66715-9859-02 Lil' 2 tablets — — FDA listed —
MEDIQUE Diamode 2 mg 85766-0120-01 Sportpharm 1 tablet — — FDA listed —
topcare anti diarrheal 2 mg 36800-0224-53 Topco 1 tablet — — FDA listed —
anti diarrheal 2 mg 56062-0224-53 Publix 1 tablet — — FDA listed —
berkley and jensen anti diarrheal 2 mg 68391-0224-01 BJWC 96 tablets — — Discontinued —
Loperamide Hydrochloride 2 mg 85766-0154-06 Sportpharm 6 tablets — — FDA listed —
dg health anti diarrheal 2 mg 55910-0224-23 Dolgencorp, 72 tablets — — Discontinued —
Loperamide Hydrochloride 2 mg 73581-0175-24 YYBA 24 tablets — — FDA listed —
Anti-Diarrheal 2 mgthis 41226-0797-22 Kroger 6 tablets — — FDA listed —
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

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

🔬 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 Anti-Diarrheal (this brand).

Top reported reactions

Diarrhoea1,762
Nausea1,042
Fatigue822
Constipation655
Vomiting642
Pyrexia608
Abdominal Pain535

Age at onset

Neonate1
Infant1
Child13
Adolescent28
Adult1,457
Elderly1,226

Reporter sex

13,298 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization5,237
Life-threatening846
Disabling259
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 887 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
41226-0797-22 You're viewing this 2 BLISTER PACK in 1 CARTON (41226-797-22) / 6 TABLET, FILM COATED in 1 BLISTER PACK 2026-09-18 Active
41226-0797-24 4 BLISTER PACK in 1 CARTON (41226-797-24) / 6 TABLET, FILM COATED in 1 BLISTER PACK 2026-09-18 Active

Pack size FAQ

What quantity is in NDC 41226-0797-22?
NDC 41226-0797-22 is listed by the FDA — 2 blister pack in 1 carton / 6 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Anti-Diarrheal Loperamide Hydrochloride 2 mg Tablet, Film Coated?
Bill NDC 41226-0797-22 — the 11-digit billing format is 41226079722. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 41226-797-22, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 41226-0797-22, written without dashes as 41226079722. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 41226-0797-22, the first segment (41226) is the labeler code FDA assigned to Kroger; the middle segment (0797) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (22) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Kroger. 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 1 other package presentation of this same product, including 6 tablets (41226-0797-24). 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?
Kroger 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.

📄 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.
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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