Anti-Diarrheal

Product NDC
55319-375
11-digit product format
553190375
Labeler code
55319
Product ID
55319-375_b2a60e21-e02e-4899-b1d5-c4697e3a3a63
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl
Dosage form
TABLET
Route
ORAL
Labeler
Family Dollar Services Inc
Application
ANDA076497
Marketing category
ANDA
Marketing start
2005-05-03
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076497-001LOPERAMIDE HYDROCHLORIDELOPERAMIDE HYDROCHLORIDE2MGTABLET / ORAL2003-06-10

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-DiarrhealLOPERAMIDE HCLFamily Dollar Services Inc769e7182-fa11-4645-8fca-657253f28d9c2026-05-27WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings 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 the stool a history of liver disease a history of abnormal heart rhythm Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs. 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 for 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Anti-Diarrheal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978010

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
55319-375-08Anti-Diarrheal4 in 1 CARTONTABLET424
55319-375-08Anti-Diarrheal6 in 1 BLISTER PACKTABLET624
55319-375-12Anti-Diarrheal2 in 1 CARTONTABLET224
55319-375-12Anti-Diarrheal6 in 1 BLISTER PACKTABLET624

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR]4
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-375ANTI-DIARRHEAL (LOPERAMIDE HCL) TABLET [FAMILY DOLLAR SERVICES INC]24Current NDC, Legacy NDC, 4 package rows20250529_769e7182-fa11-4645-8fca-657253f28d9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSN769e7182-fa11-4645-8fca-657253f28d9c25
978010loperamide hydrochloride 2 MG Oral TabletSCD769e7182-fa11-4645-8fca-657253f28d9c25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-375-08553190375084 BLISTER PACK in 1 CARTON (55319-375-08) / 6 TABLET in 1 BLISTER PACK4 blister pack2005-05-030000-00-00NoNoCurrent
55319-375-12553190375122 BLISTER PACK in 1 CARTON (55319-375-12) / 6 TABLET in 1 BLISTER PACK2 blister pack2005-05-030000-00-00NoNoCurrent