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CareOne Diarrhea and Gas Control loperamide hydrochloride, simethicone 2 mg; 125 mg Tablet, 12-count — NDC 41520-0772-53 package photo

CareOne Diarrhea and Gas Control loperamide hydrochloride, simethicone 2 mg; 125 mg Tablet, 12-count

by American Sales Company · 12 BLISTER PACK in 1 CARTON (41520-772-53) / 1 TABLET in 1 BLISTER PACK
NDC 41520-0772-53
🏷️ FDA NDC (as labeled) 41520-772-53 billing pads the product segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced Aug 27, 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

🆔 Identity & classification

FDA NDC (as labeled) 41520-772-53
Product NDC 41520-772
11-digit billing NDC 41520077253
RxCUI 978001
UNII 77TI35393C, 92RU3N3Y1O
Application # ANDA209837
SPL Set ID dfa3db5a-cef6-4ed5-b9f1-a20b6d1657b3
Physiologic effect Skin Barrier Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-01-31
Route ORAL
Dosage form TABLET
Substance LOPERAMIDE HYDROCHLORIDE; DIMETHICONE
Why two NDCs? The FDA registers this code as 41520-772-53 — 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 → 41520-0772-53. 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

LabelerAmerican Sales Company
Application holderPERRIGO R AND D CO
FDA applicationANDA209837 (ANDA)
Labeler code41520
First marketedJan 2019
Product typeHuman Otc Drug
Portfolio100 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

📖 What it is MedlinePlus · NLM

Nonprescription (over-the-counter) loperamide is used to control acute diarrhea (loose stools that come on suddenly and usually lasts less than 2 weeks), including travelers' diarrhea. Prescription loperamide is also used to control acute diarrhea and also ongoing diarrhea associated with inflammatory bowel disease (IBD; condition in which the lining of all or part of the intestine is swollen, irritated, or has sores). Prescription loperamide is also used to reduce the amount of fluid in people with ileostomies (surgery to create an opening for waste to leave the body through the abdomen). Lop...

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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
ShapeOval
ImprintL0R1;2;125
Size17 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 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 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • 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 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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.

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

The official label also statesacesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin, microcrystalline cellulose, natural and artificial flavor, propylene glycol, 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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 mgthis 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 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

🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 years 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 CareOne Diarrhea and Gas Control (this brand).

Top reported reactions

Cerebrovascular Accident1

Reporter sex

1 reports
Male · 100%

Serious outcomes

Hospitalization1
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 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
41520-0772-53 You're viewing this 12 BLISTER PACK in 1 CARTON (41520-772-53) / 1 TABLET in 1 BLISTER PACK 2019-01-31 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 41520-772-53, 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: 41520-0772-53, written without dashes as 41520077253. 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 41520-0772-53, the first segment (41520) is the labeler code FDA assigned to American Sales Company; the middle segment (0772) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (53) 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 American Sales Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
American Sales Company 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 15 words ▾

Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

⏱️ Dosage and Administration 163 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 189 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 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 caplet 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)

📦 Storage and Handling 41 words ▾

Other information • each caplet contains: calcium 165 mg, sodium 3 mg • store between 20 ° -25 ° C (68 ° -77 ° F). Protect from light. • do not use if printed foil under cap is broken or torn

🧪 Active Ingredient 12 words ▾

Active ingredients (in each caplet) Loperamide HCl 2 mg Simethicone 125 mg

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, maltodextrin, microcrystalline cellulose, natural and artificial flavor, propylene glycol, stearic acid

🎯 Purpose 3 words ▾

Purposes Anti-diarrheal Anti-gas

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 41520-0769-34 · American 41520-0778-62 · American →
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.