FDA.reportPublic FDA data

Loperamide Hydrochloride and Simethicone

Product NDC
21130-222
11-digit product format
211300222
Labeler code
21130
Product ID
21130-222_d9e5ddb4-1b09-440f-82af-b3dd59ef3ec0
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide Hydrochloride and Simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Better Living Brands, LLC
Application
ANDA211059
Marketing category
ANDA
Marketing start
2023-07-21
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
Loperamide Hydrochloride and Simethicone
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
21130-222-24Loperamide Hydrochloride and Simethicone4 in 1 CARTONTABLET43
21130-222-24Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63
21130-222-76Loperamide Hydrochloride and Simethicone6 in 1 BLISTER PACKTABLET63
21130-222-76Loperamide Hydrochloride and Simethicone3 in 1 CARTONTABLET33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-222LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLET [BETTER LIVING BRANDS, LLC]3Current NDC, 4 package rows20250112_fad9a144-6d1e-be06-e053-6394a90a870c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSNfad9a144-6d1e-be06-e053-6394a90a870c3
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCDfad9a144-6d1e-be06-e053-6394a90a870c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-222-24211300222244 BLISTER PACK in 1 CARTON (21130-222-24) / 6 TABLET in 1 BLISTER PACK4 blister pack2023-07-21NoNoCurrent
21130-222-76211300222763 BLISTER PACK in 1 CARTON (21130-222-76) / 6 TABLET in 1 BLISTER PACK3 blister pack2023-07-21NoNoCurrent