FDA.reportPublic FDA data

anti diarrheal plus anti gas

Product NDC
41250-375
11-digit product format
412500375
Labeler code
41250
Product ID
41250-375_ea6fe67a-827f-48ec-a1f7-9c619b04d8c4
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA209837
Marketing category
ANDA
Marketing start
2018-10-16
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 plus 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
41250-375-55anti diarrheal plus anti gas42 in 1 BOTTLETABLET425
41250-375-55anti diarrheal plus anti gas1 in 1 CARTONTABLET15
41250-375-62anti diarrheal plus anti gas1 in 1 BLISTER PACKTABLET15
41250-375-62anti diarrheal plus anti gas24 in 1 CARTONTABLET245
41250-375-65anti diarrheal plus anti gas30 in 1 BOTTLETABLET305
41250-375-65anti diarrheal plus anti gas1 in 1 CARTONTABLET15
41250-375-89anti diarrheal plus anti gas18 in 1 CARTONTABLET185
41250-375-89anti diarrheal plus anti gas1 in 1 BLISTER PACKTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-375ANTI DIARRHEAL PLUS ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [MEIJER DISTRIBUTION INC]5Current NDC, Legacy NDC, 8 package rows20240713_e2c9a752-618a-4e34-89a5-671aab4013ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSNe2c9a752-618a-4e34-89a5-671aab4013ac5
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCDe2c9a752-618a-4e34-89a5-671aab4013ac5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-375-55412500375551 BOTTLE in 1 CARTON (41250-375-55) > 42 TABLET in 1 BOTTLE1 bottle2018-10-160000-00-00NoNoCurrent
41250-375-624125003756224 BLISTER PACK in 1 CARTON (41250-375-62) / 1 TABLET in 1 BLISTER PACK24 blister pack2020-02-030000-00-00NoNoCurrent
41250-375-65412500375651 BOTTLE in 1 CARTON (41250-375-65) > 30 TABLET in 1 BOTTLE1 bottle2018-10-160000-00-00NoNoCurrent
41250-375-894125003758918 BLISTER PACK in 1 CARTON (41250-375-89) / 1 TABLET in 1 BLISTER PACK18 blister pack2018-10-160000-00-00NoNoCurrent