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

Additional Listing Data#

Finished product
Yes
Brand name base
Anti-Diarrheal/Anti-Gas Multi-Symptom Relief
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
79903-116-33Anti-Diarrheal/Anti-Gas Multi-Symptom Relief6 in 1 BLISTER PACKTABLET62
79903-116-33Anti-Diarrheal/Anti-Gas Multi-Symptom Relief4 in 1 CARTONTABLET42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79903-116ANTI-DIARRHEAL/ANTI-GAS MULTI-SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MG) TABLET [WAL-MART STORES, INC.]2Current NDC, Legacy NDC, 2 package rows20250112_a4d5dd69-22cf-4d00-b539-133886c09e37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSNa4d5dd69-22cf-4d00-b539-133886c09e372
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCDa4d5dd69-22cf-4d00-b539-133886c09e372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79903-116-33799030116334 BLISTER PACK in 1 CARTON (79903-116-33) / 6 TABLET in 1 BLISTER PACK4 blister pack2022-07-150000-00-00NoNoCurrent