FDA.reportPublic FDA data

dg health anti diarrheal

Product NDC
55910-224
11-digit product format
559100224
Labeler code
55910
Product ID
55910-224_2f5c1f21-2718-402e-9675-4468f35c21ba
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dolgencorp, LLC
Application
ANDA075232
Marketing category
ANDA
Marketing start
2009-12-28
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

Additional Listing Data#

Finished product
Yes
Brand name base
dg health anti diarrheal
Listing expiration
2026-12-31

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
55910-224-23dg health anti diarrheal72 in 1 BOTTLETABLET, FILM COATED7212
55910-224-23dg health anti diarrheal1 in 1 CARTONTABLET, FILM COATED112
55910-224-53dg health anti diarrheal12 in 1 CARTONTABLET, FILM COATED1212
55910-224-53dg health anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED112
55910-224-62dg health anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED112
55910-224-62dg health anti diarrheal24 in 1 CARTONTABLET, FILM COATED2412
55910-224-67dg health anti diarrheal1 in 1 CARTONTABLET, FILM COATED112
55910-224-67dg health anti diarrheal48 in 1 BOTTLETABLET, FILM COATED4812
55910-224-72dg health anti diarrheal60 in 1 BOTTLETABLET, FILM COATED6012
55910-224-72dg health anti diarrheal1 in 1 CARTONTABLET, FILM COATED112
55910-224-91dg health anti diarrheal6 in 1 CARTONTABLET, FILM COATED612
55910-224-91dg health anti diarrheal1 in 1 BLISTER PACKTABLET, FILM COATED112

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOPERAMIDE HYDROCHLORIDEACTIVE INGREDIENT77TI35393CDG HEALTH ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [DOLGENCORP, LLC]2
LOPERAMIDEACTIVE MOIETY6X9OC3H4IIDG HEALTH ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [DOLGENCORP, LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDG HEALTH ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [DOLGENCORP, LLC]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDG HEALTH ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [DOLGENCORP, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDG HEALTH ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [DOLGENCORP, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODG HEALTH ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [DOLGENCORP, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DG HEALTH ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [DOLGENCORP, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [DOLGENCORP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-224DG HEALTH ANTI DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) TABLET, FILM COATED [DOLGENCORP, LLC]12Current NDC, Legacy NDC, 12 package rows20241113_cac9e7e9-fb3a-497e-866d-347530ba4dfd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978010loperamide HCl 2 MG Oral TabletPSNcac9e7e9-fb3a-497e-866d-347530ba4dfd12
978010loperamide hydrochloride 2 MG Oral TabletSCDcac9e7e9-fb3a-497e-866d-347530ba4dfd12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-224-23559100224231 BOTTLE in 1 CARTON (55910-224-23) > 72 TABLET, FILM COATED in 1 BOTTLE1 bottle2012-09-110000-00-00NoNoCurrent
55910-224-535591002245312 BLISTER PACK in 1 CARTON (55910-224-53) / 1 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2020-07-060000-00-00NoNoCurrent
55910-224-625591002246224 BLISTER PACK in 1 CARTON (55910-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACK24 blister pack2020-02-140000-00-00NoNoCurrent
55910-224-67559100224671 BOTTLE in 1 CARTON (55910-224-67) > 48 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-12-280000-00-00NoNoCurrent
55910-224-72559100224721 BOTTLE in 1 CARTON (55910-224-72) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-05-020000-00-00NoNoCurrent
55910-224-91559100224916 BLISTER PACK in 1 CARTON (55910-224-91) > 1 TABLET, FILM COATED in 1 BLISTER PACK6 blister pack2020-07-080000-00-00NoNoCurrent