FDA.reportPublic FDA data

Loperamide Hydrochloride and Simethicone

Product NDC
58602-815
11-digit product format
586020815
Labeler code
58602
Product ID
58602-815_f2788da1-1ef1-4db9-8271-e786cc2ddd9e
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride and Simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA211059
Marketing category
ANDA
Marketing start
2020-12-14
Substance
DIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Active strength
125; 2 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Loperamide Hydrochloride and Simethicone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 mg/1
LOPERAMIDE HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii92RU3N3Y1O, 77TI35393C
Rxcui978001

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
58602-815-74Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET65
58602-815-74Loperamide Hydrochloride and Simethicone1 in 1 CARTONTABLET15
58602-815-75Loperamide Hydrochloride and Simethicone2 in 1 CARTONTABLET25
58602-815-75Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET65
58602-815-76Loperamide Hydrochloride and Simethicone4 in 1 CARTONTABLET45
58602-815-76Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET65
58602-815-80Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET65
58602-815-80Loperamide Hydrochloride and Simethicone3 in 1 CARTONTABLET35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-815-76EA - Each58602-8154cc4aa75-9dab-4aa4-9d33-3fec19413c7012021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-815LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET [AUROHEALTH LLC]5Current NDC, Legacy NDC, 8 package rows20250112_9dd3a6d6-9fff-45b3-8e76-57bf5ee2e07f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN9dd3a6d6-9fff-45b3-8e76-57bf5ee2e07f5
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD9dd3a6d6-9fff-45b3-8e76-57bf5ee2e07f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-815-74586020815741 BLISTER PACK in 1 CARTON (58602-815-74) / 6 TABLET in 1 BLISTER PACK1 blister pack2020-12-140000-00-00NoNoCurrent
58602-815-75586020815752 BLISTER PACK in 1 CARTON (58602-815-75) / 6 TABLET in 1 BLISTER PACK2 blister pack2020-12-140000-00-00NoNoCurrent
58602-815-76586020815764 BLISTER PACK in 1 CARTON (58602-815-76) / 6 TABLET in 1 BLISTER PACK4 blister pack2020-12-140000-00-00NoNoCurrent
58602-815-80586020815803 BLISTER PACK in 1 CARTON (58602-815-80) / 6 TABLET in 1 BLISTER PACK3 blister pack2020-12-140000-00-00NoNoCurrent