dg health anti diarrheal anti gas

Product NDC
55910-383
11-digit product format
559100383
Labeler code
55910
Product ID
55910-383_5cec42ac-7fba-4078-9304-90172a851312
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Dolgencorp, LLC
Application
ANDA209837
Marketing category
ANDA
Marketing start
2018-10-09
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
dg health 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
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
55910-383-53dg health anti diarrheal anti gas12 in 1 CARTONTABLET125
55910-383-53dg health anti diarrheal anti gas1 in 1 BLISTER PACKTABLET15
55910-383-62dg health anti diarrheal anti gas1 in 1 BLISTER PACKTABLET15
55910-383-62dg health anti diarrheal anti gas24 in 1 CARTONTABLET245
55910-383-89dg health anti diarrheal anti gas1 in 1 BLISTER PACKTABLET15
55910-383-89dg health anti diarrheal anti gas18 in 1 CARTONTABLET185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-383DG HEALTH ANTI DIARRHEAL ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [DOLGENCORP, LLC]5Current NDC, Legacy NDC, 6 package rows20240724_09798231-39cd-49b2-9be5-ea51e52f0a6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN09798231-39cd-49b2-9be5-ea51e52f0a6d5
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD09798231-39cd-49b2-9be5-ea51e52f0a6d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-383-535591003835312 BLISTER PACK in 1 CARTON (55910-383-53) / 1 TABLET in 1 BLISTER PACK12 blister pack2018-10-090000-00-00NoNoCurrent
55910-383-625591003836224 BLISTER PACK in 1 CARTON (55910-383-62) / 1 TABLET in 1 BLISTER PACK24 blister pack2022-04-070000-00-00NoNoCurrent
55910-383-895591003838918 BLISTER PACK in 1 CARTON (55910-383-89) / 1 TABLET in 1 BLISTER PACK18 blister pack2018-10-090000-00-00NoNoCurrent