FDA.reportPublic FDA data

Loperamide HCl and Simethicone

Product NDC
51660-069
11-digit product format
516600069
Labeler code
51660
Product ID
51660-069_86ddd92a-920c-40b8-b0bd-29bfb3b38bfc
Type
HUMAN OTC DRUG
Nonproprietary name
Loperamide HCl and Simethicone
Dosage form
TABLET
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA077500
Marketing category
ANDA
Marketing start
2022-01-13
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 HCl 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
51660-069-06Loperamide HCl and Simethicone6 in 1 BLISTER PACKTABLET63
51660-069-12Loperamide HCl and Simethicone2 in 1 CARTONTABLET23
51660-069-12Loperamide HCl and Simethicone6 in 1 BLISTER PACKTABLET63
51660-069-18Loperamide HCl and Simethicone6 in 1 BLISTER PACKTABLET63
51660-069-18Loperamide HCl and Simethicone3 in 1 CARTONTABLET33
51660-069-24Loperamide HCl and Simethicone6 in 1 BLISTER PACKTABLET63
51660-069-24Loperamide HCl and Simethicone4 in 1 CARTONTABLET43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-069LOPERAMIDE HCL AND SIMETHICONE TABLET [OHM LABORATORIES INC.]3Current NDC, Legacy NDC, 7 package rows20220908_06f99f59-e702-49f1-bb1d-e7cf58c54c30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978001loperamide HCl 2 MG / simethicone 125 MG Oral TabletPSN06f99f59-e702-49f1-bb1d-e7cf58c54c303
978001loperamide hydrochloride 2 MG / simethicone 125 MG Oral TabletSCD06f99f59-e702-49f1-bb1d-e7cf58c54c303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-069-06516600069066 TABLET in 1 BLISTER PACK (51660-069-06) 6 tablet2022-01-130000-00-00NoNoCurrent
51660-069-12516600069122 BLISTER PACK in 1 CARTON (51660-069-12) / 6 TABLET in 1 BLISTER PACK2 blister pack2022-01-130000-00-00NoNoCurrent
51660-069-18516600069183 BLISTER PACK in 1 CARTON (51660-069-18) / 6 TABLET in 1 BLISTER PACK3 blister pack2022-01-130000-00-00NoNoCurrent
51660-069-24516600069244 BLISTER PACK in 1 CARTON (51660-069-24) / 6 TABLET in 1 BLISTER PACK4 blister pack2022-01-130000-00-00NoNoCurrent