IMODIUM

Manufacturer: Kenvue Brands LLC
Effective date: 2026-08-25
Label type: HUMAN OTC DRUG LABEL
Version: 24
Source: daily-update
Hydrated at: 2026-09-01 13:02:46

Label at a glance#

ProductIMODIUM Multi-Symptom Relief

Active ingredientLOPERAMIDE HYDROCHLORIDE, DIMETHICONE

Label structure9 sections

Indications and uses

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

Dosage and administration

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 caplet...

Storage and handling

each caplet contains: calcium 165 mg, sodium 3 mg store between 20-25°C (68-77°F). Protect from light. do not use if blister unit is torn or broken

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-895-3665

PhoneLabel contact215-273-8755

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)	Purposes
Loperamide HCl 2 mg	Anti-diarrheal
Simethicone 125 mg	Anti-gas

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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
if you have difficulty swallowing

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.
you have difficulty swallowing the caplet

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

each caplet contains: calcium 165 mg, sodium 3 mg
store between 20-25°C (68-77°F). Protect from light.
do not use if blister unit is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

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

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

NDC 50580-338-52

Imodium ^®

Multi-Symptom Relief

Loperamide HCl, 2 mg /Simethicone, 125 mg Antidiarrheal/Anti-gas

Relieves symptoms
of diarrhea plus

Cramps & Pressure
Bloating
Gas

24 Caplets*

*capsule-shaped tablets

Actual Size

immodium-1.jpg

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0300450212627	GTIN-13: 0300450212627 EAN-13: 0300450212627 GTIN-12: 300450212627 UPC-A: 300450212627 GTIN storage (14 digits): 00300450212627	immodium-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
10f838ef-a72b-645d-80f8-e2255205c3b1	Product name	6	20240805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-338-12	EA - Each	50580-338	98056e1f-993f-4dd8-a5dd-b63528eda74c	1	2013-07-02
50580-338-18	EA - Each	50580-338	a8d1002b-0f8b-42fc-acf9-b8ace53acdcf	1	2013-07-02
50580-338-30	EA - Each	50580-338	c686b314-ade6-4385-b915-3c115c5d9a21	1	2013-07-02
50580-338-42	EA - Each	50580-338	5d616fac-b4ee-4f71-9679-b2a20b4ef3ae	1	2013-07-02
50580-338-61	EA - Each	50580-338	d9877b44-8edd-4c7a-a250-52835559fbd3	1	2020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	6
Loperamide Hydrochloride	ACTIVE INGREDIENT	77TI35393C	6
Dimethicone	ACTIVE MOIETY	92RU3N3Y1O	6
Loperamide	ACTIVE MOIETY	6X9OC3H4II	6
acesulfame potassium	INACTIVE INGREDIENT	23OV73Q5G9	6
calcium phosphate, dibasic, dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	6
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	6
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	6
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	6

Products#

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

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

IMODIUM Multi-Symptom Relief
loperamide hydrochloride and dimethicone
LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE
DIMETHICONE
CROSCARMELLOSE SODIUM
ACESULFAME POTASSIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MICROCRYSTALLINE CELLULOSE
STEARIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-338	50580-338-12, 50580-338-18, 50580-338-42, 50580-338-30, 50580-338-60, 50580-338-61, 50580-338-64, 50580-338-06, 50580-338-07, 50580-338-52, 50580-338-51, 50580-338-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LOPERAMIDE HYDROCHLORIDE	77TI35393C	ACTIB
DIMETHICONE	92RU3N3Y1O	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
STEARIC ACID	4ELV7Z65AP	IACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
23	2026-01-23	full-release	2026-06-01 01:35:40

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 65 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL	111 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL	111 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
calcium phosphate, dibasic, dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL	111 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
calcium phosphate, dibasic, dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL	111 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
calcium phosphate, dibasic, dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
calcium phosphate, dibasic, dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL	111 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL	111 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
calcium phosphate, dibasic, dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
calcium phosphate, dibasic, dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL	111 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL	111 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
calcium phosphate, dibasic, dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL	111 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL	111 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL	111 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
calcium phosphate, dibasic, dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
acesulfame potassium	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET / ORAL	111 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
calcium phosphate, dibasic, dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
calcium phosphate, dibasic, dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
croscarmellose sodium	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / ORAL	736 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
calcium phosphate, dibasic, dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
calcium phosphate, dibasic, dihydrate	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL	2442 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL	6184 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates

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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET / ORAL		RLD, RS	2000-11-30

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021140-001	IMODIUM MULTI-SYMPTOM RELIEF	2MG;125MG	TABLET / ORAL	RLD, RS	2000-11-30	`f41ea6bd6efb…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IMODIUM Multi-Symptom Relief	LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE	Kenvue Brands LLC	ecb91e47-2b0c-47c8-9256-4623d8bc825e	2026-08-25	Warnings	Exact identifier ndc (package): 50580-338-60 ndc (package): 50580-338-51 ndc (package): 50580-338-12 ndc (package): 50580-338-42 ndc (package): 50580-338-61 ndc (package): 50580-338-50 ndc (package): 50580-338-07 ndc (package): 50580-338-64 ndc (package): 50580-338-18 ndc (package): 50580-338-06 ndc (package): 50580-338-30 ndc (package): 50580-338-52 ndc (product): 50580-338 ndc11 (package): 50580033860 ndc11 (package): 50580033806 ndc11 (package): 50580033850 ndc11 (package): 50580033807 ndc11 (package): 50580033852 ndc11 (package): 50580033812 ndc11 (package): 50580033861 ndc11 (package): 50580033818 ndc11 (package): 50580033864 ndc11 (package): 50580033851 ndc11 (package): 50580033830 ndc11 (package): 50580033842 spl id: 598d9530-ac42-e032-e063-6394a90a1edc spl set id: ecb91e47-2b0c-47c8-9256-4623d8bc825e

Reported adverse events (FAERS/openFDA)#

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