FDA.reportPublic FDA data

good sense anti diarrheal anti gas

Product NDC
0113-0087
11-digit product format
001130087
Labeler code
0113
Product ID
0113-0087_7fbd19ec-7b82-4f11-95f0-28801a9c64b4
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
2018-10-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
good sense anti diarrheal anti gas
Listing expiration
2027-12-31

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
0113-0087-53good sense anti diarrheal anti gas1 in 1 BLISTER PACKTABLET15
0113-0087-53good sense anti diarrheal anti gas12 in 1 CARTONTABLET125
0113-0087-62good sense anti diarrheal anti gas24 in 1 CARTONTABLET245
0113-0087-62good sense anti diarrheal anti gas1 in 1 BLISTER PACKTABLET15
0113-0087-65good sense anti diarrheal anti gas30 in 1 BOTTLETABLET305
0113-0087-65good sense anti diarrheal anti gas1 in 1 CARTONTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0087-53EA - Each0113-0087c4c0edab-92a0-4ad8-b865-742611bf77ee12021-07-15
0113-0087-65EA - Each0113-0087d88b3db6-254a-4c4e-bf46-672b79422aba12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0087GOOD SENSE ANTI DIARRHEAL ANTI GAS (LOPERAMIDE HYDROCHLORIDE, SIMETHICONE) TABLET [L. PERRIGO COMPANY]4Current NDC, Legacy NDC, 6 package rows20240711_2cda08a8-3f5e-430c-84a3-d29b97d647af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN2cda08a8-3f5e-430c-84a3-d29b97d647af5
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD2cda08a8-3f5e-430c-84a3-d29b97d647af5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0087-530011300875312 BLISTER PACK in 1 CARTON (0113-0087-53) / 1 TABLET in 1 BLISTER PACK12 blister pack2018-10-110000-00-00NoNoCurrent
0113-0087-620011300876224 BLISTER PACK in 1 CARTON (0113-0087-62) / 1 TABLET in 1 BLISTER PACK24 blister pack2019-06-100000-00-00NoNoCurrent
0113-0087-65001130087651 BOTTLE in 1 CARTON (0113-0087-65) > 30 TABLET in 1 BOTTLE1 bottle2018-10-160000-00-00NoNoCurrent