Loperamide Hydrochloride

Manufacturer
Atlantic Biologicals Corps
Effective date
2019-10-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:00:51

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

use enclosed dosage cup to accurately measure dosage as noted below drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and older 4 teaspoonfuls (1 dosage cup) after the first loose bowel movement; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose bowel movement; ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful)

Loperamide HCl 1 mg

Purpose

OTC - PURPOSE SECTION

Antidiarrheal

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

if you have bloody or black stool Do not use

Ask a doctor before use if you have

  • high fever (greater than 101°F)
  • mucus present in your stool
  • a history of liver disease

taking antibiotics Ask doctor or pharmacist before use if you are

diarrhea lasts for more than 2 days Stop use and ask a doctor if

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

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

  • use enclosed dosage cup to accurately measure dosage as noted below
  • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
adults and children 12 years and older4 teaspoonfuls (1 dosage cup) after the first loose bowel movement; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose bowel movement; but no more than 8 teaspoonfuls a day
children 9-11 years (60-95 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 6 teaspoonfuls a day
children 6-8 years (48-59 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 4 teaspoonfuls a day
children under 6 years (up to 47 lbs)ask a doctor (not intended for use in children under 6 years old)

Other information

SPL UNCLASSIFIED SECTION

  • 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. 618:05 4/12

LOPERAMIDE HYDROCHLORIDE SOLUTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
977986loperamide HCl 1 MG in 5 mL Oral SolutionPSN5
977986loperamide hydrochloride 0.2 MG/ML Oral SolutionSCD5
977986loperamide hydrochloride 1 MG per 5 ML Oral SolutionSY5
977986loperamide hydrochloride 2 MG per 10 ML Oral SolutionSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0618-12021-01-29C16284748780-1ba0f9c33-47fd-a910-e053-dadaa90a0b85Drug Facts
17856-0618-52021-01-29C16284748780-1ba0f9c33-47fd-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0618-1Loperamide Hydrochloride10 mL in 1 CUPSOLUTION105
17856-0618-5Loperamide Hydrochloride5 mL in 1 CUPSOLUTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0618LOPERAMIDE HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORPS]5Legacy NDC, 2 package rows20191017_b0596b9c-326d-4795-b0a5-38c858af7a77.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-618-04ML - Milliliter50383-6188b63b39a-50bc-4955-a19f-2bf658aab63812012-07-24
50383-618-05ML - Milliliter50383-618cebec501-71fb-4138-b911-b4abaea5d47912013-10-17
50383-618-06ML - Milliliter50383-6184aff43b9-f08c-42f0-891d-7d579728476b12013-08-02
50383-618-10ML - Milliliter50383-61887fa7eba-05a0-4c90-b62a-deeca64cc69a12013-10-17
50383-618-11ML - Milliliter50383-618fdcbc23c-0d0d-4c51-9133-220296523bcb12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393C4
LOPERAMIDEACTIVE MOIETY6X9OC3H4II4
ALCOHOLINACTIVE INGREDIENT3K9958V90M4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL4
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM4
CHERRYINACTIVE INGREDIENTBUC5I9595W4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
MINTINACTIVE INGREDIENTFV98Z8GITP4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU4
SORBITOLINACTIVE INGREDIENT506T60A25R4
SUCROSEINACTIVE INGREDIENTC151H8M5544
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-061817856-0618-1, 17856-0618-5
50383-618

Ingredients#

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

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

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 ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRA-ARTICULAR45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL48 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii candidate
44 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM, AUGMENTED / TOPICAL15 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / BUCCAL30 mgExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLPOWDER, FOR SUSPENSION / ORAL570 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RAEROSOL, FOAM / TOPICAL4.95 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMCREAM / TOPICAL6 mgExact identifier — unii candidate
23 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, EXTENDED RELEASE / ORAL9 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
SUCROSESUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMELIXIR / ORAL90 mgExact identifier — unii candidate
23 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / ORALNAExact 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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074352-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-1784e616aacf4f…
2026-08-18 06:07:402026-07A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-173f01610625f2…
2019-09-15 20:21 UTC2019-09A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074352-001LOPERAMIDE HYDROCHLORIDE1MG/5MLSOLUTION / ORAL1995-11-17f41ea6bd6efb…

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
5a00eb66-d425-467c-a2d8-6e82a701348bb0596b9c-326d-4795-b0a5-38c858af7a772019-10-16WarningsExact identifier
spl id: 5a00eb66-d425-467c-a2d8-6e82a701348b
spl set id: b0596b9c-326d-4795-b0a5-38c858af7a77

Reported adverse events (FAERS/openFDA)#

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