FDA.reportPublic FDA data

Imodium A-D

Manufacturer
Kenvue Brands LLC
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:28:06

Label at a glance#

ProductImodium A-D
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

drink plenty of clear fluids to help prevent dehydration caused by diarrhea not for use in children under 12 years of age adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Storage and handling

store at 20°-25°C (68°-77°F). Protect from light. avoid excessive heat above 40°C (104°F) do not use if blister unit is torn or broken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 2 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

WARNINGS SECTION

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
  • in children under 12 years of age

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.

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Heart alert

SPL UNCLASSIFIED SECTION

Taking more than directed can cause serious heart problems or death

Do not use

OTC - DO NOT USE SECTION

  • if you have bloody or black stool
  • in children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

OTC - WHEN USING SECTION

When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms get worse
  • diarrhea lasts for more than 2 days
  • you get abdominal swelling or bulging. These may be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • not for use in children under 12 years of age
  • adults and children 12 years and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F). Protect from light.
  • avoid excessive heat above 40°C (104°F)
  • do not use if blister unit is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxyanisole, edible ink, FD&C blue no. 1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-367-02

Imodium ®

A-D

Loperamide HCl, 2mg/Anti-Diarrheal

Soft Gelatin Capsules

Anti-Diarrheal
Softgels

Controls the symptoms
of diarrhea

Suitable for adults and

children 12 years and over

24 Softgels*

Actual Size

*each liquid-filled capsule contains 2 mg loperamide HCl

imodium-01imodium-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978009Imodium 2 MG Oral CapsulePSN10
978006loperamide HCl 2 MG Oral CapsulePSN10
978009loperamide hydrochloride 2 MG Oral Capsule [Imodium]SBD10
978006loperamide hydrochloride 2 MG Oral CapsuleSCD10
978009Imodium 2 MG Oral CapsuleSY10

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LOPERAMIDE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130300450137241GTIN-13: 0300450137241
EAN-13: 0300450137241
GTIN-12: 300450137241
UPC-A: 300450137241
GTIN storage (14 digits): 00300450137241		Imdodium-01.jpg
Data codeCode 128126044Imdodium-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-367-01Imodium A-D1 in 1 CARTONCAPSULE, LIQUID FILLED110
50580-367-01Imodium A-D12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
50580-367-02Imodium A-D12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1210
50580-367-02Imodium A-D2 in 1 CARTONCAPSULE, LIQUID FILLED210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-367-01EA - Each50580-3677fb643da-a81a-4130-9c1c-65c3a40deecd12019-05-02
50580-367-02EA - Each50580-36792d6ba5b-5582-4f90-9293-f54a53fade4512017-03-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-36750580-367-01, 50580-367-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
WATER059QF0KO0RIACT
LOPERAMIDE HYDROCHLORIDE77TI35393CACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021855-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04
N021855-002LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04c2088c7a36db…
2026-10-15 13:18:302026-09N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04c2088c7a36db…
2026-09-14 22:38:342026-08N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0484e616aacf4f…
2026-09-14 22:38:342026-08N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0484e616aacf4f…
2026-08-18 06:07:402026-07N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04caaa826d4ba7…
2026-08-18 06:07:402026-07N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021855-001LOPERAMIDE HYDROCHLORIDE1MGCAPSULE / ORALRLD2005-08-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021855-002LOPERAMIDE HYDROCHLORIDE2MGCAPSULE / ORALRLD, RS2005-08-044b0b4de00fa7…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Imodium A-DLOPERAMIDE HYDROCHLORIDEKenvue Brands LLC31bfcbb4-c58c-4edc-ac68-356a448b75072025-12-22WarningsExact identifier
ndc (package): 50580-367-01
ndc (package): 50580-367-02
ndc (product): 50580-367
ndc11 (package): 50580036702
ndc11 (package): 50580036701
spl id: 460d0a84-5c0c-b974-e063-6294a90ab761
spl set id: 31bfcbb4-c58c-4edc-ac68-356a448b7507

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.