FDA.reportPublic FDA data

Good Sense anti diarrheal

Manufacturer
Northwind Health Company, LLC
Effective date
2026-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:35:08

Label at a glance#

ProductGood Sense anti diarrheal
Active ingredientLOPERAMIDE HYDROCHLORIDE
Label structure9 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. 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; 1/2 caplet after each subsequent...

Storage and handling

store at 20°-25°C (68°-77°F) see end panel for lot number and expiration date

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Loperamide HCl 2 mg

Purpose

OTC - PURPOSE SECTION

Anti-diarrheal

Use

INDICATIONS & USAGE SECTION

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

WARNINGS SECTION

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

Heart alert: Taking more than directed can cause serious heart problems or death

Do not use

OTC - DO NOT USE SECTION

if you have bloody or black stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  1. fever
  2. mucus in the stool
  3. a history of liver disease
  4. a history of abnormal heart rhythm

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. Loperamide may interact with certain prescription drugs.

When using this product

OTC - WHEN USING SECTION

tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 (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.

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; 1/2 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; 1/2 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

  1. store at 20°-25°C (68°-77°F)
  2. see end panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous lactose, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-663-54

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
978010loperamide HCl 2 MG Oral TabletPSN2
978010loperamide hydrochloride 2 MG Oral TabletSCD2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00351655663547(21)000000000000000(17)000000(10)0000000000GTIN-14: 00351655663547
GTIN-12: 351655663547
UPC-A: 351655663547
EAN-13: 0351655663547
GTIN storage (14 digits): 00351655663547		51655-663-54 - Rev A 03-21 NHC.jpg
Data codeCode 128000000000051655-663-54 - Rev A 03-21 NHC.jpg

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-663-54Good Sense anti diarrheal15 in 1 BAGTABLET, FILM COATED152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0224-53EA - Each0113-022482f37fcd-535a-4658-ae9d-02adb360891a12012-07-24
0113-0224-62EA - Each0113-02245fc913a4-4865-4137-9e4b-9fe452f8de5912016-09-02
0113-0224-89EA - Each0113-02246379b962-3cbe-4ac9-a7de-c1304f605d8512012-07-24
0113-0224-91EA - Each0113-02244b818f88-0e14-405e-9562-867abab5243b12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51655-66351655-663-54
0113-0224

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
LOPERAMIDE HYDROCHLORIDE77TI35393CACTIB

Source Document#

Source XML

Orange Book application contexts#

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 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
A075232-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06

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 22:38:342026-08A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0684e616aacf4f…
2026-08-18 06:07:402026-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063f01610625f2…
2019-09-15 20:21 UTC2019-09A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075232-001LOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2000-01-06f41ea6bd6efb…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDEL. Perrigo Company9c1d811d-f8d0-418c-aaf7-7b6477deea202026-05-20WarningsExact identifier
ndc (product): 0113-0224
Good Sense anti diarrhealLOPERAMIDE HYDROCHLORIDENorthwind Health Company, LLCdb47cc0a-e301-0310-e053-2a95a90a7f5d2026-01-01WarningsExact identifier
ndc (package): 51655-663-54
ndc (product): 51655-663
ndc11 (package): 51655066354
spl id: 4950ae3a-d3c7-b948-e063-6394a90afa44
spl set id: db47cc0a-e301-0310-e053-2a95a90a7f5d

Reported adverse events (FAERS/openFDA)#

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