Imodium

Manufacturer: Kenvue Brands LLC
Effective date: 2025-09-23
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 01:14:51

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 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 st...

Storage and handling

each 30 mL contains: sodium 16 mg store between 20-25°C (68-77°F) do not use if outer neck band imprinted with "Imodium®" or inner neck band imprinted with "Sealed For Your Safety" is broken or missing

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

Active ingredient (in each 7.5 mL)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 1 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

controls symptoms of diarrhea, including Travelers' Diarrhea

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

OTC - DO NOT USE SECTION

Do not use if you have bloody or black stool

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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

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 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 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

Other information

STORAGE AND HANDLING SECTION

each 30 mL contains: sodium 16 mg
store between 20-25°C (68-77°F)
do not use if outer neck band imprinted with "Imodium®" or inner neck band imprinted with "Sealed For Your Safety" is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

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 50580-134-08

Imodium ^®
A-D

Loperamide HCl Oral Solution

Anti-Diarrheal
1 mg per 7.5 mL

Anti-Diarrheal
Oral Solution

Controls the symptoms

of diarrhea

8 fl oz
(240 mL)

Mint Flavor

imodium-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1250693	Imodium A-D 1 MG in 7.5 mL Oral Suspension	PSN	10
1250685	loperamide HCl 1 MG in 7.5 mL Oral Suspension	PSN	10
1250693	loperamide hydrochloride 0.133 MG/ML Oral Suspension [Imodium]	SBD	10
1250685	loperamide hydrochloride 0.133 MG/ML Oral Suspension	SCD	10
1250693	Imodium 0.133 MG/ML Oral Suspension	SY	10
1250693	Imodium A-D 1 MG per 7.5 ML Oral Suspension	SY	10
1250685	loperamide HCl 1 MG per 7.5 ML Oral Solution	SY	10
1250685	loperamide hydrochloride 1 MG per 7.5 ML Oral Suspension	SY	10

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LOPERAMIDE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-134-04	ImodiumA-D	120 mL in 1 BOTTLE	SOLUTION	120	10
50580-134-08	ImodiumA-D	240 mL in 1 BOTTLE	SOLUTION	240	10
50580-134-44	ImodiumA-D	120 mL in 1 BOTTLE	SOLUTION	120	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-134-04	ML - Milliliter	50580-134	bfdfb816-6cb3-44da-8e3a-011ee1011bfe	1	2012-07-24
50580-134-08	ML - Milliliter	50580-134	0dd4bb36-574a-42f4-90f0-a567f747976a	1	2012-07-24
50580-134-44	ML - Milliliter	50580-134	87ed0291-7636-44f0-88c9-325ba3d85b84	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Loperamide Hydrochloride	ACTIVE INGREDIENT	77TI35393C	3
Loperamide	ACTIVE MOIETY	6X9OC3H4II	3
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	3
carboxymethylcellulose sodium, unspecified form	INACTIVE INGREDIENT	K679OBS311	3
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	3
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	3
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	3
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	3
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	3
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	3
water	INACTIVE INGREDIENT	059QF0KO0R	3
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	3

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Imodium A-D
Loperamide Hydrochloride
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
CARAMEL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GLYCERIN
MICROCRYSTALLINE CELLULOSE
PROPYLENE GLYCOL
SODIUM BENZOATE
SUCRALOSE
TITANIUM DIOXIDE
WATER
XANTHAN GUM
LOPERAMIDE
ANHYDROUS CITRIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-134	50580-134-04, 50580-134-44, 50580-134-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	K679OBS311	IACT
CARAMEL	T9D99G2B1R	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GLYCERIN	PDC6A3C0OX	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT
XANTHAN GUM	TTV12P4NEE	IACT
LOPERAMIDE HYDROCHLORIDE	77TI35393C	ACTIB
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT

Source Document#

Source XML

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 4 · 224 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii+route 100 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / ORAL		3900 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii+route 100 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii+route 88 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE / ORAL		29520 mg	Exact identifier — unii+route 100 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii+route 88 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii+route 88 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii+route 100 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii+route 100 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route 88 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, DELAYED RELEASE PARTICLES / ORAL		580 mg	Exact identifier — unii+route 100 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii+route 100 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route 88 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii+route 88 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii+route 88 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii+route 88 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii+route 100 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii+route 88 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii+route 88 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route 88 equally ranked IID candidates
D&C yellow no. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / ORAL		8 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii+route 100 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii+route 88 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 88 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii+route 88 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii+route 88 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii+route 100 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1576 mg	Exact identifier — unii+route 100 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, EXTENDED RELEASE / ORAL		1246 mg	Exact identifier — unii+route 100 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route 88 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii+route 88 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii+route 100 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, COATED PELLETS / ORAL		456 mg	Exact identifier — unii+route 100 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route 88 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii+route 100 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii+route 100 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii+route 100 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii+route 100 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii+route 88 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C blue no. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / ORAL	1.13 mg/15ml		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii+route 88 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FOR SUSPENSION / ORAL		20100 mg	Exact identifier — unii+route 100 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii+route 88 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii+route 100 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii+route 100 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route 100 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii+route 88 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii+route 100 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii+route 100 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii+route 88 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii+route 88 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route+dosage form 4 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019487-001	IMODIUM A-D	LOPERAMIDE HYDROCHLORIDE	1MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	1988-03-01
N019487-002	IMODIUM A-D	LOPERAMIDE HYDROCHLORIDE	1MG/7.5ML	SOLUTION / ORAL		RLD, RS	2004-07-08

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 · 86 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	N019487-001	IMODIUM A-D	1MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1988-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019487-002	IMODIUM A-D	1MG/7.5ML	SOLUTION / ORAL	RLD, RS	2004-07-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019487-001	IMODIUM A-D	1MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	1988-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019487-002	IMODIUM A-D	1MG/7.5ML	SOLUTION / ORAL	RLD, RS	2004-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD	1988-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019487-002	IMODIUM A-D	1MG/7.5ML	SOLUTION / ORAL	RLD, RS	2004-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD	1988-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019487-002	IMODIUM A-D	1MG/7.5ML	SOLUTION / ORAL	RLD, RS	2004-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD	1988-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019487-001	IMODIUM A-D	1MG/5ML	SOLUTION / ORAL	RLD, RS	1988-03-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019487-002	IMODIUM A-D	1MG/7.5ML	SUSPENSION / ORAL	RLD, RS	2004-07-08	`74a2ff9319b5…`

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 A-D	LOPERAMIDE HYDROCHLORIDE	Kenvue Brands LLC	76a976d5-8bee-4158-a94d-7fbfc5544fd4	2025-09-23	Warnings	Exact identifier ndc (package): 50580-134-04 ndc (package): 50580-134-08 ndc (package): 50580-134-44 ndc (product): 50580-134 ndc11 (package): 50580013408 ndc11 (package): 50580013404 ndc11 (package): 50580013444 spl id: 3f73b325-ad6b-8e65-e063-6394a90a361e spl set id: 76a976d5-8bee-4158-a94d-7fbfc5544fd4

Reported adverse events (FAERS/openFDA)#

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