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Loperamide Hydrochloride 2 mg Tablet, 12-count — NDC 63868-0338-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Loperamide Hydrochloride 2 mg Tablet, 12-count — NDC 63868-338-12 (Billing 63868-0338-12)

by Chain Drug Marketing Association Inc. · 12 TABLET in 1 BLISTER PACK

This is a package of 12 tablets of Loperamide Hydrochloride 2 mg Tablet from Chain Drug Marketing Association Inc., marketed since Feb 1993 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 63868-0338-12
🏷️ FDA NDC (as labeled) 63868-338-12 billing pads the product segment with a zero
This package
Contains12-count Pack sizes3 compare ↓
Main listing for product 63868-338 · Also comes in: 24 tablets 63868-338-24 60 tablets 63868-338-60
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

NDC database record

One package, one record: these facts belong to NDC 63868-338-12 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63868 labeler · 338 product · 12 package
Package marketed since
Feb 1, 1993
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
12 EA per package
Barcode (UPC-A, from the NDC)
3 6386833812 9
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63868-338-12
Product NDC 63868-338
11-digit billing NDC 63868033812
NCPDP billing unit EA — each (per item)
RxCUI 978010
UNII 77TI35393C
Application # ANDA074091
SPL Set ID 237b845b-0f02-410d-9750-c95123e6142d
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 1993-02-01
Route ORAL
Dosage form TABLET
Substance LOPERAMIDE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 47100020100305
GPI class QC Anti-Diarrheal
GCN Seq No 013672
GCN 08550
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 QC ANTI-DIARRHEAL 2 MG CAPLET
FDB brand name Anti-Diarrheal
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 013672
  • GCN: 08550
  • GPI-14 (Medi-Span): 47100020100305
  • HICL (First Databank): 001236
  • AHFS class code: 56:08.00.00
  • RxCUI (RxNorm): 978010
Why two NDCs? The FDA registers this code as 63868-338-12 — 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 → 63868-0338-12. 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

Label name QC ANTI-DIARRHEAL 2 MG CAPLET Ingredient Loperamide Hcl
📖 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 ↗
📗 Our plain-language guide HelloPharmacist
  • It controls the symptoms of diarrhea, including travelers' diarrhea in over-the-counter products. Prescription-labeled capsules are also used for chronic diarrhea in adults with in...
  • Take it by mouth, usually after loose stools, following the label chart for your age and weight. Drink lots of clear fluids so you don't get dehydrated. With liquids, shake well an...
  • No. Taking more than directed can cause serious, even fatal, heart rhythm problems. If diarrhea lasts more than 2 days or gets worse, stop and call your doctor.
  • Can I take extra if the diarrhea isn't stopping?
📖 Read our full Loperamide guide →

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.

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: 24 tablets 60 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63868-0338-12 You're viewing this Main listing 12 TABLET in 1 BLISTER PACK 1993-02-01 — Active
63868-0338-24 63868-338-24 24 TABLET in 1 BLISTER PACK 1993-02-01 — Active
63868-0338-60 63868-338-60 60 TABLET in 1 BOTTLE 1993-02-01 — Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 12-count package — 12 tablet in 1 blister pack.
How does this package differ from NDC 63868-0338-24?
Both are Loperamide Hydrochloride 2 mg Tablet — the drug itself is identical. This page's package is the 12-count one, while NDC 63868-0338-24 is the 24 tablets package.
What NDC number is used to bill for this package of Loperamide Hydrochloride 2 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense anti diarrheal 2 mg 00113-0224-53 L. 1 tablet $0.130 — Availability likely —
anti diarrheal 2 mg 00113-2224-62 L. 1 tablet $0.130 — Availability likely —
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 —
leader anti diarrheal 2 mg 70000-0589-01 Cardinal 1 tablet $0.130 — Availability likely —
foster and thrive anti diarrheal 2 mg 70677-1106-01 Strategic 1 tablet $0.130 — Availability likely —
Anti Diarrheal 2 mg 83324-0064-12 Chain 12 tablets $0.130 — Availability likely —
Anti Diarrheal 2 mg 63868-0559-12 CHAIN 12 tablets $0.147 — FDA listed —
injoy diarrhea relief 2 mg 00113-6004-62 L. 1 tablet — — FDA listed —
Anti-Diarrheal 2 mg 00363-0375-02 Walgreen 12 tablets — — FDA listed —
anti diarrheal 2 mg 00363-1010-53 Walgreen 1 tablet — — FDA listed —
Up and Up anti diarrheal 2 mg 11673-0224-02 Target 24 tablets — — Discontinued —
Anti-Diarrheal 2 mg 11822-0375-03 Rite 12 tablets — — FDA listed —
Anti-Diarrheal 2 mg 21130-0375-08 Better 24 tablets — — FDA listed —
Loperamide Hydrochloride 2mg 2 mg 25000-0001-83 MARKSANS 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 29485-9286-02 Lil' 25 tablets — — FDA listed —
Anti-Diarrheal 2 mg 30142-0775-02 Kroger 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 35418-0123-12 Zee 12 tablets — — FDA listed —
topcare anti diarrheal 2 mg 36800-0224-53 Topco 1 tablet — — FDA listed —
Anti-Diarrheal 2 mg 37808-0375-08 H 24 tablets — — FDA listed —
Anti Diarrheal 2 mg 37808-0552-23 H 72 tablets — — Discontinued —
Anti-diarrheal 2 mg 37835-0131-01 BI-MART 100 tablets — — FDA listed —
Anti-Diarrheal 2 mg 41163-0375-02 United 12 tablets — — FDA listed —
anti diarrheal 2 mg 41250-0224-53 Meijer 1 tablet — — FDA listed —
CareOne Diarrhea Control 2 mg 41520-0813-53 American 1 tablet — — 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 —
MEDIQUE Diamode 2 mg 47682-0400-46 Unifirst 1 tablet — — FDA listed —
Anti Diarrheal 2 mg 49035-0375-08 Wal-Mart 24 tablets — — FDA listed —
Imodium A-D 2 mg 50580-0317-01 Kenvue 6 tablets — — FDA listed —
Anti-Diarrheal 2 mg 50844-0259-02 L.N.K. 12 tablets — — FDA listed —
Anti-diarrheal 2 mg 50844-0375-02 L.N.K. 12 tablets — — FDA listed —
Loperamide HCl 2 mg 50844-0735-02 L.N.K. 12 tablets — — FDA listed —
Good Sense anti diarrheal 2 mg 51655-0663-54 Northwind 15 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 51660-0123-06 Ohm 6 tablets — — FDA listed —
Anti-Diarrheal 2 mg 53117-0248-86 First 6 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 53329-0664-57 Medline 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 53943-0123-12 Discount 12 tablets — — FDA listed —
Anti-Diarrheal 2 mg 53943-0375-02 Discount 12 tablets — — FDA listed —
Anti Diarrheal 2 mg 55301-0375-02 ARMY 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 55315-0123-06 Fred's 6 tablets — — FDA listed —
Anti-Diarrheal 2 mg 55319-0375-08 Family 24 tablets — — FDA listed —
dg health anti diarrheal 2 mg 55910-0224-23 Dolgencorp, 72 tablets — — Discontinued —
Anti-Diarrheal 2 mg 55910-0375-08 DOLGENCORP, 24 tablets — — FDA listed —
anti diarrheal 2 mg 56062-0224-53 Publix 1 tablet — — FDA listed —
Anti-Diarrheal 2 mg 57896-0381-13 Geri-Care 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 58602-0701-01 Aurohealth 6 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 58602-0870-76 Aurohealth 24 tablets — — FDA listed —
anti diarrheal 2 mg 59779-0700-53 CVS 1 tablet — — FDA listed —
anti diarrheal 2 mg 59779-0960-62 CVS 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 63187-0462-12 Proficient 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mgthis 63868-0338-12 Chain 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 63941-0123-12 Valu 12 tablets — — FDA listed —
Anti-Diarrheal 2 mg 63941-0375-02 Valu 12 tablets — — FDA listed —
Anti-Diarrheal 2 mg 66424-0725-24 SDA 24 tablets — — FDA listed —
Anti-Diarrheal, 24/7 Life by 7-Eleven 2 mg 66715-4644-04 Lil' 12 tablets — — FDA listed —
Anti-Diarrheal, Circle K 2 mg 66715-5529-02 Lil' 4 tablets — — FDA listed —
Anti-Diarrheal, Caseys 4good 2 mg 66715-6359-02 Lil' 4 tablets — — FDA listed —
Anti-Diarrheal, CVP HEALTH 2 mg 66715-6559-02 Lil' 4 tablets — — FDA listed —
Lil Drug Store Anti-Diarrheal 2 mg 66715-9859-02 Lil' 2 tablets — — FDA listed —
Anti-Diarrheal 2 mg 67091-0335-18 WinCo 12 tablets — — FDA listed —
anti diarrheal 2 mg 67296-1472-07 Redpharm 24 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 —
Anti-diarrheal 2 mg 68016-0301-06 Chain 6 tablets — — Discontinued —
berkley and jensen anti diarrheal 2 mg 68391-0224-01 BJWC 96 tablets — — Discontinued —
Loperamide Hydrochloride 2 mg 68788-8393-02 Preferred 24 tablets — — FDA listed —
Good Sense anti diarrheal 2 mg 68788-8750-02 Preferred 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 68998-0123-24 Marc 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 69168-0248-86 Allegiant 6 tablets — — FDA listed —
Leader Anti Diarrheal 2 mg 70000-0225-01 Cardinal 1 tablet — — Discontinued —
Good Sense anti diarrheal 2 mg 71205-0079-12 Proficient 1 tablet — — FDA listed —
MEDIQUE Diamode 2 mg 71205-0316-01 Proficient 1 tablet — — FDA listed —
basic care loperamide hydrochloride 2 mg 72288-0224-62 Amazon.com 1 tablet — — FDA listed —
Amazon Basic Care Loperamide Hydrochloride 2 mg 72288-0225-76 Amazon.com 24 tablets — — FDA listed —
WELMATE Anti Diarrheal Loperamide HCl 2 mg 73581-0101-24 YYBA 24 tablets — — FDA listed —
Anti Diarrheal 2 mg 73581-0171-24 Yyba 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 80136-0063-11 Heartland 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 80513-0375-08 Advanced 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 80513-0401-24 Advanced 24 tablets — — FDA listed —
Amazon Basic Care Loperamide Hydrochloride 2 mg 82804-0295-06 Proficient 6 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 —
MEDIQUE Diamode 2 mg 85766-0120-01 Sportpharm 1 tablet — — FDA listed —
Loperamide Hydrochloride 2 mg 85766-0154-06 Sportpharm 6 tablets — — FDA listed —
Anti-Diarrheal 2 mg 85828-0248-93 Grocery 12 tablets — — FDA listed —
Loperamide Hydrochloride 2 mg 73581-0175-24 YYBA 24 tablets — — FDA listed —
Anti-Diarrheal 2 mg 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

🏛️
1993
On the market since
Feb 1993
📍
2026
Currently FDA-listed
33 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.

What it looks like

Color green
ShapeCapsule
Imprint123
Size9 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.

🧪 Avoiding an ingredient? See Loperamide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • 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 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • 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 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 Z82Y2C65EA
    Hydrogenated cottonseed oil is a solid fat made by adding hydrogen to cottonseed oil. It's used in medicines as a binder and lubricant to help hold ingredients together and make tablets easier to compress and release.
  • 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 SMD1X3XO9M
    Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

The official label also statesanhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

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

LabelerChain Drug Marketing Association Inc.
Application holderOHM LABORATORIES INC
FDA applicationANDA074091 (ANDA)
Labeler code63868
First marketedFeb 1993
Product typeHuman Otc Drug
Portfolio72 products on file

More NDCs from Chain Drug Marketing Association Inc. labeler code 63868

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 ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

Use controls symptoms of diarrhea, including Travelers' Diarrhea

⏱️ Dosage and Administration 134 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. 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 168 words ▾

Warnings Allergy alert Do not use 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 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 38 words ▾

Other information store between 20° – 25°C (68° – 77°F) see side panel for lot number and expiration date TAMPER EVIDENT: THIS PRODUCT IS PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

🧪 Active Ingredient 10 words ▾

Active ingredient (in each caplet) Loperamide Hydrochloride USP, 2 mg

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

🎯 Purpose 2 words ▾

Purpose Anti-diarrheal

📄 Do Not Use 10 words ▾

Do not use if you have bloody or black stool

📄 Ask a Doctor Before Use If 24 words ▾

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 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 31 words ▾

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 10 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).

📄 Questions or Comments 12 words ▾

Questions? Call toll-free Monday-Friday 8:30 am to 5 pm EST at 1800-406-7984.

📄 Package Label / Principal Display Panel 62 words ▾

PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton QUALITY ® CHOICE NDC 63868-338-12 *Compare to Active Ingredient in IMODIUM ® A-D See New Warnings and Directions Loperamide Hydrochloride Tablets USP, 2 mg Anti-Diarrheal Controls The Symptoms of Diarrhea 12 Caplets* Each caplet (*capsule-shaped tablet) contains Loperamide Hydrochloride USP, 2 mg PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton

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 Chain Drug Marketing Association Inc.. 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 2 other package presentations of this same product, including 24 tablets (63868-0338-24), 60 tablets (63868-0338-60). 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?
Chain Drug Marketing Association 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.
← 63868-0334-15 · CHAIN 63868-0339-12 · QUALITY →
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.