FDA.reportPublic FDA data

Good Sense antidiarrheal

Product NDC
0113-1645
11-digit product format
001131645
Labeler code
0113
Product ID
0113-1645_e0ecb853-b59b-4fe3-808a-6736d896d53d
Type
HUMAN OTC DRUG
Nonproprietary name
loperamide HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
L. Perrigo Company
Application
ANDA091292
Marketing category
ANDA
Marketing start
2018-05-21
Substance
LOPERAMIDE HYDROCHLORIDE
Active strength
1 mg/7.5mL
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
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 antidiarrheal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOPERAMIDE HYDROCHLORIDE1 mg/7.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii77TI35393C
Rxcui1250685

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-1645-26Good Sense antidiarrheal120 mL in 1 BOTTLESOLUTION1204
0113-1645-34Good Sense antidiarrheal240 mL in 1 BOTTLESOLUTION2404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-1645-26ML - Milliliter0113-164552ad8745-ad04-4f5f-a4f7-e3079d01614c12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-1645GOOD SENSE ANTIDIARRHEAL (LOPERAMIDE HCL) SOLUTION [L. PERRIGO COMPANY]3Current NDC, Legacy NDC, 2 package rows20250416_9928de7e-c148-4a19-a946-d4af911c2631.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN9928de7e-c148-4a19-a946-d4af911c26314
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSNae8237f0-95a6-4163-b476-25c0509ef1514
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD9928de7e-c148-4a19-a946-d4af911c26314
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCDae8237f0-95a6-4163-b476-25c0509ef1514
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY9928de7e-c148-4a19-a946-d4af911c26314
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSYae8237f0-95a6-4163-b476-25c0509ef1514
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY9928de7e-c148-4a19-a946-d4af911c26314
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSYae8237f0-95a6-4163-b476-25c0509ef1514
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN0d1eb0dc-991b-4e54-bae1-3660bddc62432
1250685loperamide HCl 1 MG in 7.5 mL Oral SuspensionPSN672ca656-6abb-42d4-8dbc-9f3428c350582
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD0d1eb0dc-991b-4e54-bae1-3660bddc62432
1250685loperamide hydrochloride 0.133 MG/ML Oral SuspensionSCD672ca656-6abb-42d4-8dbc-9f3428c350582
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY0d1eb0dc-991b-4e54-bae1-3660bddc62432
1250685loperamide HCl 1 MG per 7.5 ML Oral SolutionSY672ca656-6abb-42d4-8dbc-9f3428c350582
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY0d1eb0dc-991b-4e54-bae1-3660bddc62432
1250685loperamide hydrochloride 1 MG per 7.5 ML Oral SuspensionSY672ca656-6abb-42d4-8dbc-9f3428c350582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-1645-2600113164526120 mL in 1 BOTTLE (0113-1645-26) 120 ml2018-05-210000-00-00NoNoCurrent
0113-1645-3400113164534240 mL in 1 BOTTLE (0113-1645-34) 240 ml2025-08-14NoNoCurrent