Good Sense Anti Diarrheal Anti Gas

Product NDC
0113-1087
11-digit product format
001131087
Labeler code
0113
Product ID
0113-1087_ccd55b11-1c5f-4854-ba98-98193943f509
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide hydrochloride, simethicone
Dosage form
TABLET
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA209837
Marketing category
ANDA
Marketing start
2019-01-29
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
Good Sense 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
0113-1087-89Good Sense Anti Diarrheal Anti Gas18 in 1 CARTONTABLET182
0113-1087-89Good Sense Anti Diarrheal Anti Gas1 in 1 BLISTER PACKTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-1087-89EA - Each0113-10871c4da606-4930-4fe7-86ff-52e401b730dd12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1087GOOD SENSE ANTI DIARRHEAL ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [L. PERRIGO COMPANY]2Current NDC, Legacy NDC, 2 package rows20240715_fcfd0b64-6876-4e6f-8a7b-ca1da9e03f00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSNfcfd0b64-6876-4e6f-8a7b-ca1da9e03f002
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCDfcfd0b64-6876-4e6f-8a7b-ca1da9e03f002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-1087-890011310878918 BLISTER PACK in 1 CARTON (0113-1087-89) / 1 TABLET in 1 BLISTER PACK18 blister pack2019-01-290000-00-00NoNoCurrent