Loperamide Hydrochloride

Manufacturer: Akorn | Akorn Operating Company LLC
Effective date: 2022-03-14
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 22:06:08

Label at a glance#

ProductLoperamide Hydrochloride

Active ingredientLOPERAMIDE HYDROCHLORIDE

Label structure9 sections

Indications and uses

• controls the symptoms of diarrhea, including Traveler's Diarrhea

Dosage and administration

• drink plenty of clear fluid to help prevent dehydration caused by diarrhea • find right dose on chart. If possible, use weight to dose; otherwise use age. • Use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. • TSP = teaspoonful = milliliter adults and children 12 years and older 4 teaspoonfuls (20 mL) after the first loose stool movement; 2 teaspoonf...

Contacts and useful links#

PhoneLabel contact1-800-262-9010

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful)

Loperamide HCl 1 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Uses

INDICATIONS & USAGE SECTION

controls the symptoms of diarrhea, including Traveler's 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

Ask a doctor before use if you have

fever
mucus in your stool
a history of liver disease

Ask doctor or pharmacist before use if you are taking antibiotics

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 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

drink plenty of clear fluid to help prevent dehydration caused by diarrhea
find right dose on chart. If possible, use weight to dose; otherwise use age.
Use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
TSP = teaspoonful = milliliter

adults and children 12 years and older	4 teaspoonfuls (20 mL) after the first loose stool movement; 2 teaspoonfuls (10 mL) after each subsequent loose stool; but no more than 8 teaspoonfuls (40 mL) a day
children 9-11 years (60-95 lbs)	2 teaspoonfuls (10 mL) after the first loose stool movement; 1 teaspoonfuls (5 mL) after each subsequent loose stool; but no more than 6 teaspoonfuls (30 mL) a day
children 6-8 years (48-59 lbs)	2teaspoonfuls (10 mL) after the first loose stool movement; 1 teaspoonfuls (5 mL) after each subsequent loose stool; but no more than 4 teaspoonfuls (20 mL) a day
children 2-5 years (34 to 47 lbs)	ask a doctor
children under 2 years (up to 33 lbs)	do not use

Other information

SPL UNCLASSIFIED SECTION

Each 20 mL contains: sodium 3.2 mg
avoid excess heat
store at room temperature, 15° - 30°C (59° - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol (0.5%), benzoic acid, cherry flavor, glycerin, mint flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose. Citric acid may be used to adjust pH

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-262-9010

Mon. - Thurs. 9:00 am - 4:30 pm EST,

Fri. 9:00 am - 2:30 pm EST

Serious side effects associated with use of this product may be reported to this number.

Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701

Rev. 618:07 05/18

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx Choice

NDC 50383-618-04

See New Warnings and Directions

Loperamide Hydrochloride Oral Solution

1 mg/5 mL

Anti-Diarrheal

Controls the Symptoms of Diarrhea, including Traveler’s Diarrheal

Each teaspoonful (5 mL) contains: Loperamide Hydrochloride 1 mg

Contains Alcohol 0.5%

Convenient dosage cup enclosed.

4 fl oz (118 mL)

Cherry Mint Flavor

HI-TECH PHARMACAL CO., INC.

Amityville, NY 11701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50383-618-04	ML - Milliliter	50383-618	8b63b39a-50bc-4955-a19f-2bf658aab638	1	2012-07-24
50383-618-05	ML - Milliliter	50383-618	cebec501-71fb-4138-b911-b4abaea5d479	1	2013-10-17
50383-618-06	ML - Milliliter	50383-618	4aff43b9-f08c-42f0-891d-7d579728476b	1	2013-08-02
50383-618-10	ML - Milliliter	50383-618	87fa7eba-05a0-4c90-b62a-deeca64cc69a	1	2013-10-17
50383-618-11	ML - Milliliter	50383-618	fdcbc23c-0d0d-4c51-9133-220296523bcb	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LOPERAMIDE HYDROCHLORIDE	ACTIVE INGREDIENT	77TI35393C	3
LOPERAMIDE	ACTIVE MOIETY	6X9OC3H4II	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	3
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	3
CHERRY	INACTIVE INGREDIENT	BUC5I9595W	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	3
MINT	INACTIVE INGREDIENT	FV98Z8GITP	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Loperamide Hydrochloride
LOPERAMIDE
ALCOHOL
ANHYDROUS CITRIC ACID
BENZOIC ACID
CHERRY
GLYCERIN
MINT
PROPYLENE GLYCOL
SODIUM BENZOATE
SORBITOL
SUCROSE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50383-618	50383-618-04, 50383-618-05, 50383-618-06, 50383-618-10, 50383-618-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LOPERAMIDE HYDROCHLORIDE	77TI35393C	ACTIB
ALCOHOL	3K9958V90M	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
BENZOIC ACID	8SKN0B0MIM	IACT
CHERRY	BUC5I9595W	IACT
GLYCERIN	PDC6A3C0OX	IACT
MINT	FV98Z8GITP	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SORBITOL	506T60A25R	IACT
SUCROSE	C151H8M554	IACT
WATER	059QF0KO0R	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 8 · 428 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LOZENGE / TRANSMUCOSAL		44 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	INJECTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 23 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / SUBCUTANEOUS		101 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / ORAL		2590 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	ELIXIR / ORAL		90 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	PASTE / ORAL		26 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / TOPICAL	4.35 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		35 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET / BUCCAL		30 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SOLUTION / ORAL		123 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 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 44.

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
A074352-001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL			1995-11-17

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074352-001	LOPERAMIDE HYDROCHLORIDE	1MG/5ML	SOLUTION / ORAL	1995-11-17	`3a93d1ddd44b…`

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
e57ce11d-a796-46cb-90ad-a39a92152c93			3a624112-2903-43fb-9c6b-a9a4fc03da9c	2022-05-25	Warnings	Exact identifier spl set id: 3a624112-2903-43fb-9c6b-a9a4fc03da9c

Reported adverse events (FAERS/openFDA)#

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