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Over-the-counter medicine

Dimethicone and loperamide Brand names: Imodium

Dimethicone and loperamide (Imodium) is an over-the-counter medicine. FDA's NDC Directory lists it from 33 generic labelers, and pharmacies paid $0.286 per unit (Gs anti-diarrheal-antigas cplt) in the October 7, 2026 NADAC survey.

  • Generic listed
  • Over the counter

Check it at the source: the dimethicone and loperamide FDA label on DailyMed (effective August 25, 2026); every dimethicone and loperamide label on DailyMed.

Highlights of the record

FDA label of August 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage

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

Forms and strengths

  • 2 mg / 125 mg
  • 125 mg / 2 mg

Tablet.

On the market

Generic approvals
No generic approved
Labelers listed (NDC)
34 of which 33 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
$0.286 per unit Gs anti-diarrheal-antigas cplt
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
31,902 through July 30, 2026

What is dimethicone and loperamide used for?

From the label: indications and usage

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

Conditions named in the indications of dimethicone and loperamide's FDA labels, with every medicine labeled for each:

From other dimethicone and loperamide labels

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

FDA pharmacologic class: Opioid Agonist.

Source: FDA drug label (IMODIUM Multi-Symptom Relief), Kenvue Brands LLC, effective August 25, 2026 (SPL set ecb91e47-2b0c-47c8-9256-4623d8bc825e), via openFDA; the full label on DailyMed

Is there a generic for dimethicone and loperamide (Imodium)?

No generic dimethicone and loperamide is approved (Drugs@FDA, October 8, 2026).

FDA's NDC Directory lists dimethicone and loperamide from 33 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for dimethicone and loperamide (Imodium)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.286 per unit (Gs anti-diarrheal-antigas cplt), about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Gs anti-diarrheal-antigas cplt (generic)
$0.307
$0.264
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Ft anti-diarrheal-antigas cpltGeneric$0.286 per unitn/a-0.9%
Gnp anti-diarrheal-gas cpltGeneric$0.286 per unitn/a-0.9%
Gs anti-diarrheal-antigas cpltGeneric$0.286 per unitn/a-0.9%
Loperamide-simeth 2-125 mg tabletGeneric$0.286 per tablet$8.57-0.9%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What do FAERS reports show for dimethicone and loperamide?

The FDA Adverse Event Reporting System holds 31,902 reports that list dimethicone and loperamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,527 are coded as a death and 11,229 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Diarrhoea (named in the label)6,494
  • Drug Ineffective (a use or a product term, not a reaction)3,149
  • Nausea3,103
  • Fatigue2,620
  • Off Label Use (a use or a product term, not a reaction)2,258
  • Vomiting2,126
  • Constipation1,778
  • Weight Decreased1,520

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as dimethicone and loperamide?

9 other medicines are given the same way (oral) and in the same FDA class as dimethicone and loperamide or labeled mainly for the same use (diarrhea), the same class first. Diarrhea lists all 16 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
Bismuth subsalicylateDiarrheanone listed$0.0817 per tablet 262 mg tablet chewableNo current entry
CiprofloxacinDiarrhea46 labelers$0.123 per tablet 500 mg tabletNo current entry
Atropine and diphenoxylateDiarrhea19 labelers$0.139 per tablet 2.5-0.025 mg tabletNo current entry
NitazoxanideDiarrhea4 labelers$82.20 per tablet 500 mg tabletNo current entry
RifaximinDiarrheanone listedn/aNo current entry
Atropine and difenoxinDiarrheanone listed$6.91 per tablet 1-0.025 mg tabletNo current entry
OctreotideDiarrheanone listedn/aNo current entry
TelotristatDiarrheanone listedn/aNo current entry

Every medicine labeled for the same conditions as dimethicone and loperamide

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to dimethicone and loperamide
9 medicines for the same use
Other opioids
the pharmacologic class, with prices and generics
Dimethicone and loperamide side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other