HomeNDC LookupIngredientsLoperamide Hcl › 70000-0417-01
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(from DailyMed)

leader anti diarrheal loperamide HCl 1 mg/7.5mL Solution, 120 mL

by Cardinal Health 110, LLC. dba Leader · 120 mL in 1 BOTTLE (70000-0417-1)
NDC 70000-0417-01
🏷️ FDA NDC (as labeled) 70000-0417-1 billing pads the package 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) 70000-0417-1
Product NDC 70000-0417
11-digit billing NDC 70000041701
NCPDP billing unit ML — per mL (volume)
RxCUI 1250685
UNII 77TI35393C
UPC 0096295135428
Application # ANDA091292
SPL Set ID c27e6fbd-8822-4784-9d24-497ae78e54f4
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 2018-07-16
Route ORAL
Dosage form SOLUTION
Substance LOPERAMIDE HYDROCHLORIDE
GPI-14 47100020102005
GPI class Anti-Diarrheal
GCN Seq No 059430
GCN 25065
HICL code 001236
Ingredient (HICL) Loperamide Hcl
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 56:08.00.00
AHFS class Antidiarrhea Agents
FDB label name ANTI-DIARRHEAL 1 MG/7.5 ML SOL
FDB brand name Anti-Diarrheal
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0417-1 — 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 → 70000-0417-01. 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

LabelerCardinal Health 110, LLC. dba Leader
Application holderPERRIGO R AND D CO
FDA applicationANDA091292 (ANDA)
Labeler code70000
First marketedJul 2018
Product typeHuman Otc Drug
Portfolio162 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

Label name ANTI-DIARRHEAL 1 MG/7.5 ML SOL Ingredient Loperamide Hcl
📗 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.

🧪 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 XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesanhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

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 DailyMedingredient 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 mLPer package
Retail pharmacies payNADAC · weekly $0.027 $3.18 / 120 ml
Medicaid paysCMS SDUD · 12 mo $0.0853 $10.24 / 120 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.027 $0.025
▲ Up 6% over the last 24 months.
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 antidiarrheal 1 mg/7.5mL 00113-1645-26 L. 120 ml $0.026 Availability likely
loperamide hydrochloride 1 mg/7.5mL 00904-6836-20 Major 120 ml $0.026 Availability likely
good neighbor pharmacy loperamide hydrochloride 1 mg/7.5mL 46122-0544-26 Amerisource 120 ml $0.026 Availability likely
leader anti diarrheal 1 mg/7.5mLthis 70000-0417-01 Cardinal 120 ml $0.026 Availability likely
leader anti diarrheal 1 mg/7.5mL 70000-0418-01 Cardinal 120 ml $0.026 Availability likely
foster and thrive anti-diarrheal 1 mg/7.5mL 70677-1107-01 Strategic 1 bottle $0.026 Availability likely
Anti Diarrheal 1 mg/7.5mL 00363-2022-26 Walgreen 120 ml FDA listed
Up and Up anti diarrheal 1 mg/7.5mL 11673-0900-34 Target 240 ml FDA listed
loperamide hydrochloride 1 mg/7.5mL 11822-5519-01 Rite 120 ml Discontinued
loperamide hydrochloride 1 mg/7.5mL 17856-6836-01 ATLANTIC 72 cups FDA listed
anti-diarrheal 1 mg/7.5mL 21130-0381-34 Safeway 240 ml FDA listed
signature care anti diarrheal 1 mg/7.5mL 21130-0440-34 Safeway 1 bottle Discontinued
anti diarrheal 1 mg/7.5mL 30142-0514-34 Kroger 236 ml FDA listed
topcare loperamide hydrochloride 1 mg/7.5mL 36800-0583-26 Topco 120 ml FDA listed
anti diarrheal 1 mg/7.5mL 37808-0449-34 H 240 ml FDA listed
equaline loperamide hydrochloride 1 mg/7.5mL 41163-0210-26 United 120 ml FDA listed
loperamide hydrochloride 1 mg/7.5mL 41250-0813-26 Meijer 120 ml FDA listed
CareOne Diarrhea Control 1 mg/7.5mL 41520-0841-26 American 120 ml FDA listed
Equate Loperamide Hydrochloride 1 mg/7.5mL 49035-0451-34 Wal-Mart 240 ml FDA listed
equate diarrhea control 1 mg/7.5mL 49035-0695-26 Wal-Mart 118 ml FDA listed
Imodium A-D 1 mg/7.5mL 50580-0134-04 Kenvue 120 ml FDA listed
Loperamide Hydrochloride 1 mg/7.5mL 55910-0155-55 DOLGENCORP 120 ml FDA listed
DG Health Anti Diarrheal 1 mg/7.5mL 55910-0867-26 Dolgencorp 118 ml FDA listed
Loperamide Hydrochloride 1 mg/7.5mL 68094-0029-62 Precision 10 cups FDA listed
Loperamide Hydrochloride 1 mg/7.5mL 68094-0129-62 Precision 10 cups FDA listed
loperamide hydrochloride 1 mg/7.5mL 68788-7842-01 Preferred 120 ml FDA listed
Good Sense antidiarrheal 1 mg/7.5mL 68788-8796-01 Preferred 120 ml FDA listed
loperamide hydrochloride oral 1 mg/7.5mL 69452-0405-55 BIONPHARMA 120 ml FDA listed
Loperamide hydrochloride 1 mg/7.5mL 69842-0191-26 CVS 120 ml FDA listed
basic care loperamide hydrochloride 1 mg/7.5mL 72288-0645-34 Amazon.com 240 ml FDA listed
basic care loperamide hydrochloride 1 mg/7.5mL 72288-0758-26 Amazon.com 120 ml FDA listed
Loperamide Hydrochloride 1 mg/7.5mL 81033-0067-34 Kesin 30 cups FDA listed
Loperamide Hydrochloride 1 mg/7.5mL 72288-0048-34 Amazon.com 240 ml 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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70000-0417-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.1K
Units reimbursed last 4 qtrs
124.3K
Gross reimbursed last 4 qtrs
$10.6K
Avg / prescription
$9.82
Avg / unit
$0.0853
Latest quarter Q4 2025
193Rx
Medicaid pays / mL
$0.0853
gross reimbursed
vs
NADAC / mL
$0.0265
acquisition cost
=
Spread
+$0.0588
+222% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
58% FFS 42% MCO
Fee-for-service · 624 Rx Managed care · 456 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 17,425 units · 174 per 100k residents MI New York: 46,115 units · 236 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 13,243 units · 143 per 100k residents NJ Massachusetts: no data reported MA California: 22,424 units · 57.5 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 1,620 units · 35.8 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 1,320 units · 44.9 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 22,191 units · 72.8 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
35.8236
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 236 /100k
2 Michigan 174 /100k
3 New Jersey 143 /100k
4 Texas 72.8 /100k
5 California 57.5 /100k
6 Kansas 44.9 /100k
7 Kentucky 35.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Loperamide (matched by generic name) — the program that covers self-administered drugs. 10 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Loperamide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.64M
Claims incl. refills
241.9K
Beneficiaries
170.9K
Spend / beneficiary
$21.31
Spend / claim
$15.06
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 leader anti diarrheal (this brand).

Top reported reactions

Diarrhoea403
Nausea183
Vomiting162
Fatigue151
Dehydration137
Pyrexia125
Death115

Age at onset

Adolescent1
Adult39
Elderly44

Reporter sex

2,408 reports
Male · 50%
Female · 50%
Unknown · 0%

Serious outcomes

Hospitalization1,250
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 110 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
70000-0417-01 You're viewing this 120 mL in 1 BOTTLE (70000-0417-1) 2018-07-16 Active

📄 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 8 words

Use controls symptoms of diarrhea, including Travelers’ Diarrhea

⏱️ Dosage and Administration 165 words

Directions • drink plenty of clear fluids to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise use age. • shake well before using • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. • mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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 175 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 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.

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 19 words

Other information • each 30 mL contains: sodium 15 mg • store between 20-25 ° C (68-77 ° F)

🧪 Active Ingredient 10 words

Active ingredient (in each 7.5 mL) Loperamide HCl 1 mg

🧪 Inactive Ingredients 35 words

Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

🎯 Purpose 2 words

Purpose Anti-diarrheal

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.