Anti-Diarrheal/Anti-Gas Caplets

Product NDC
73581-178
11-digit product format
735810178
Labeler code
73581
Product ID
73581-178_3cb7329c-a47c-5d2f-e063-6394a90a053d
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride 2mg, Simethicone 125mg
Dosage form
TABLET
Route
ORAL
Labeler
YYBA CORP
Application
ANDA213484
Marketing category
ANDA
Marketing start
2021-09-10
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
Anti-Diarrheal/Anti-Gas Caplets
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
73581-178-24Anti-Diarrheal/Anti-Gas Caplets4 in 1 CARTONTABLET41
73581-178-24Anti-Diarrheal/Anti-Gas Caplets6 in 1 BLISTER PACKTABLET61

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN46f5c653-eec2-4729-8aaa-79f2e188eac31
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD46f5c653-eec2-4729-8aaa-79f2e188eac31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73581-178-24735810178244 BLISTER PACK in 1 CARTON (73581-178-24) / 6 TABLET in 1 BLISTER PACK4 blister pack2025-07-24NoNoCurrent