anti diarrheal and anti gas

Product NDC
69842-644
11-digit product format
698420644
Labeler code
69842
Product ID
69842-644_927820f7-afd0-4433-9202-86729b523a61
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA209837
Marketing category
ANDA
Marketing start
2019-08-06
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 and anti gas
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
69842-644-53anti diarrheal and anti gas12 in 1 CARTONTABLET124
69842-644-53anti diarrheal and anti gas1 in 1 BLISTER PACKTABLET14
69842-644-62anti diarrheal and anti gas1 in 1 BLISTER PACKTABLET14
69842-644-62anti diarrheal and anti gas24 in 1 CARTONTABLET244

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-644ANTI DIARRHEAL AND ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [CVS PHARMACY]4Current NDC, Legacy NDC, 4 package rows20240724_065699b5-217e-432f-a253-cea2d3f62233.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN065699b5-217e-432f-a253-cea2d3f622334
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD065699b5-217e-432f-a253-cea2d3f622334

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-644-536984206445312 BLISTER PACK in 1 CARTON (69842-644-53) / 1 TABLET in 1 BLISTER PACK12 blister pack2022-10-250000-00-00NoNoCurrent
69842-644-626984206446224 BLISTER PACK in 1 CARTON (69842-644-62) / 1 TABLET in 1 BLISTER PACK24 blister pack2019-08-060000-00-00NoNoCurrent