Anti-Diarrheal/Anti-Gas Multi-Symptom Relief

Product NDC
79903-116
11-digit product format
799030116
Labeler code
79903
Product ID
79903-116_f6ae2fa7-3ea7-4643-8bce-75b3a4f2558f
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride 2mg, Simethicone 125mg
Dosage form
TABLET
Route
ORAL
Labeler
Wal-Mart Stores, Inc.
Application
ANDA214541
Marketing category
ANDA
Marketing start
2022-07-15
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
92RU3N3Y1ODIMETHICONE9006-65-9DIMETHICONE
77TI35393CLOPERAMIDE HYDROCHLORIDE34552-83-5LOPERAMIDE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-116-33799030116334 BLISTER PACK in 1 CARTON (79903-116-33) / 6 TABLET in 1 BLISTER PACK4 blister pack2022-07-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Equate Anti-diarrheal/ Anti-gas Multi-Symptom ReliefWal-Mart Stores, Inc.2025-01-09Human OTC Drug Label2