CareOne Diarrhea Control

Product NDC
41520-841
11-digit product format
415200841
Labeler code
41520
Product ID
41520-841_073b5ad8-c4b0-4a3b-bf58-c4b6ab14af0a
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Sales Company
Application
ANDA091292
Marketing category
ANDA
Marketing start
2016-11-23
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
CareOne Diarrhea Control
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
41520-841-26CareOne Diarrhea Control120 mL in 1 BOTTLESUSPENSION1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-841CAREONE DIARRHEA CONTROL (LOPERAMIDE HYDROCHLORIDE) SUSPENSION [AMERICAN SALES COMPANY]4Current NDC, Legacy NDC, 1 package rows20200407_95ba9c92-77f5-4344-a4f3-78eda9ebc823.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN95ba9c92-77f5-4344-a4f3-78eda9ebc8235
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD95ba9c92-77f5-4344-a4f3-78eda9ebc8235
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY95ba9c92-77f5-4344-a4f3-78eda9ebc8235
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY95ba9c92-77f5-4344-a4f3-78eda9ebc8235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-841-2641520084126120 mL in 1 BOTTLE (41520-841-26) 120 ml2016-11-230000-00-00NoNoCurrent