antidiarrheal multi symptom relief

Product NDC
56062-511
11-digit product format
560620511
Labeler code
56062
Product ID
56062-511_37b3e1b3-2c85-45ae-959d-9d33c5c9d685
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Publix Super Markets Inc
Application
ANDA209837
Marketing category
ANDA
Marketing start
2020-08-03
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
antidiarrheal 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
56062-511-62antidiarrheal multi symptom relief24 in 1 CARTONTABLET242
56062-511-62antidiarrheal multi symptom relief1 in 1 BLISTER PACKTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-511ANTIDIARRHEAL MULTI SYMPTOM RELIEF (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [PUBLIX SUPER MARKETS INC]2Current NDC, Legacy NDC, 2 package rows20200818_addb2c44-bab0-430a-8305-281f30a66d87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSNaddb2c44-bab0-430a-8305-281f30a66d872
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCDaddb2c44-bab0-430a-8305-281f30a66d872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
56062-511-625606205116224 BLISTER PACK in 1 CARTON (56062-511-62) / 1 TABLET in 1 BLISTER PACK24 blister pack2020-08-030000-00-00NoNoCurrent