DG Health Anti Diarrheal

Product NDC
55910-867
11-digit product format
559100867
Labeler code
55910
Product ID
55910-867_2c3f24e0-1183-4389-b504-5c8ac8ec1081
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Dolgencorp Inc
Application
ANDA091292
Marketing category
ANDA
Marketing start
2022-07-27
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
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 HYDROCHLORIDE1 mg/7.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui1250685

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
55910-867-26DG Health Anti Diarrheal118 mL in 1 BOTTLESOLUTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-867DG HEALTH ANTI DIARRHEAL (LOPERAMIDE HCL) SOLUTION [DOLGENCORP INC]2Current NDC, Legacy NDC, 1 package rows20250416_46e3046f-0aea-4848-b5ab-bac4ff0c7f2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN46e3046f-0aea-4848-b5ab-bac4ff0c7f2e2
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD46e3046f-0aea-4848-b5ab-bac4ff0c7f2e2
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY46e3046f-0aea-4848-b5ab-bac4ff0c7f2e2
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY46e3046f-0aea-4848-b5ab-bac4ff0c7f2e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-867-2655910086726118 mL in 1 BOTTLE (55910-867-26) 118 ml2022-07-270000-00-00NoNoCurrent