Anti-Diarrheal

Product NDC
55910-176
11-digit product format
559100176
Labeler code
55910
Product ID
55910-176_e08f6085-d26e-518a-e053-2995a90a0495
Type
HUMAN OTC DRUG
Nonproprietary name
LOPERAMIDE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
DOLGENCORP, LLC
Application
NDA021855
Marketing category
NDA
Marketing start
2018-08-17
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
Anti-Diarrheal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui978006

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
55910-176-08Anti-Diarrheal1 in 1 CARTONCAPSULE, LIQUID FILLED14
55910-176-08Anti-Diarrheal12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
55910-176-12Anti-Diarrheal12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
55910-176-12Anti-Diarrheal2 in 1 CARTONCAPSULE, LIQUID FILLED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-176ANTI-DIARRHEAL (LOPERAMIDE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [DOLGENCORP, LLC]4Current NDC, Legacy NDC, 4 package rows20220604_d1fd9a92-9d96-4921-b789-c1f710ee2351.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978006loperamide HCl 2 MG Oral CapsulePSNd1fd9a92-9d96-4921-b789-c1f710ee23514
978006loperamide hydrochloride 2 MG Oral CapsuleSCDd1fd9a92-9d96-4921-b789-c1f710ee23514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-176-08559100176081 BLISTER PACK in 1 CARTON (55910-176-08) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2022-06-030000-00-00NoNoCurrent
55910-176-12559100176122 BLISTER PACK in 1 CARTON (55910-176-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2018-08-170000-00-00NoNoCurrent