Loperamide Hydrochloride and Simethicone 125 mg; 2 mg Tablet, 100-count
by IMO-GEN LABS LLC · 100 TABLET in 1 BOTTLE (84441-713-10)
NDC 84441-0713-10
🏷️ FDA NDC (as labeled)
84441-713-10
billing pads the product segment with a zero
OTC
Generic
On market
Non-controlled
🗂️ Data synced Jul 24, 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)
84441-713-10
Product NDC
84441-713
11-digit billing NDC
84441071310
RxCUI
978001
UNII
92RU3N3Y1O, 77TI35393C
UPC
0860010278123
Application #
ANDA211438
SPL Set ID
41d6dba5-e411-c8d2-e063-6294a90ae8fa
Physiologic effect
Skin Barrier Activity
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-10-23
Route
ORAL
Dosage form
TABLET
Substance
DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 84441-713-10 — 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 → 84441-0713-10. 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.
🏭 Manufacturer & labeler
LabelerIMO-GEN LABS LLC
Application holderHETERO LABS LTD UNIT V
FDA applicationANDA211438 (ANDA)
Labeler code84441
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio2 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
Patient education
Supplement & herbal interactions
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.
💬 Questions about Loperamide Hydrochloride and Simethicone?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeCapsule
ImprintH;L21
Size17 mm
ScoringScored — splits in 2
FlavorVanilla
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 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 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 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 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.
5 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesacesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor
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 system | Per each | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| good sense anti diarrheal anti gas 2 mg/1; 125 mg 00113-0087-53 | L. | 12 tablets | $0.287 | — | Availability likely | — |
| good neighbor pharmacy anti diarrheal anti gas 2 mg/1; 125 mg 46122-0620-62 | Amerisource | 24 tablets | $0.287 | — | Availability likely | — |
| foster and thrive anti diarrheal anti gas 2 mg/1; 125 mg 70677-1105-01 | Strategic | 12 tablets | $0.287 | — | 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 mg 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 mgthis 84441-0713-10 | IMO-GEN | 100 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
🏛️
2025
On the market since
Oct 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.
🔬 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 Loperamide Hydrochloride and Simethicone — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 17%
Female · 83%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 84441-0713-10 You're viewing this | 100 TABLET in 1 BOTTLE (84441-713-10) | 2025-10-23 | Active |
🧭 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 84441-713-10, 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: 84441-0713-10, written without dashes as 84441071310. 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 84441-0713-10, the first segment (84441) is the labeler code FDA assigned to IMO-GEN LABS LLC; the middle segment (0713) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 IMO-GEN LABS LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
IMO-GEN LABS LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
📄 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
🎯 Indications and Usage ▾
USE(S) relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
⏱️ Dosage and Administration ▾
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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9-11 years (60-95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6-8 years (48-59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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 ▾
WARNINGS Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride HEART ALERT Taking more than directed can cause serious heart problems or death. DO NOT USE • if you have bloody or black stool • if you have difficulty swallowing ASK A DOCTOR BEFORE USE IF YOU HAVE • fever • mucus in the stool • a history of liver disease • a history of abnormal heart rhythm 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 tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. STOP USE AND ASK A 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 tablet If pregnant or breast-feeding , ask a health professional before use. 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.
(1-800-222-1222)
HEART ALERT Taking more than directed can cause serious heart problems or death.
🧪 Active Ingredient ▾
ACTIVE INGREDIENT(S) (in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 125 mg
🧪 Inactive Ingredients ▾
INACTIVE INGREDIENTS acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor
🎯 Purpose ▾
PURPOSES Anti-diarrheal Anti-gas
No label section mentions that — try another word, or open the full label on DailyMed below.
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.