anti diarrheal anti gas

Product NDC
11822-1003
11-digit product format
118221003
Labeler code
11822
Product ID
11822-1003_fba8aafb-b3cc-47e3-bb57-596831aee9f2
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA209837
Marketing category
ANDA
Marketing start
2019-01-03
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
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-1003-1118221003011 BOTTLE in 1 CARTON (11822-1003-1) > 42 TABLET in 1 BOTTLE1 bottle2019-01-030000-00-00NoNoCurrent
11822-1003-21182210030212 BLISTER PACK in 1 CARTON (11822-1003-2) / 1 TABLET in 1 BLISTER PACK12 blister pack2019-01-030000-00-00NoNoCurrent
11822-1003-31182210030324 BLISTER PACK in 1 CARTON (11822-1003-3) / 1 TABLET in 1 BLISTER PACK24 blister pack2020-02-240000-00-00NoNoCurrent